PRINTER'S NO. 940
No. 851 Session of 1971
INTRODUCED BY MR. BERKES, MRS. CRAWFORD, MRS. ANDERSON, MESSRS.
GREENFIELD, SCANLON, MILLER, SAVITT, J. H. HAMILTON,
GALLAGHER, KNEPPER, BRAIG, R. W. WILT, MELTON, FEE,
MRS. KELLY, MESSRS. BELLOMINI, DeMEDIO, HASKELL, DOMBROWSKI,
RITTER, BLAIR, D. S. HAYES, O'PAKE, PIEVSKY, FINEMAN,
ENGLEHART, IRVIS, MRS. FAWCETT, MESSRS. O'BRIEN, KURY,
WANSACZ, MALADY, COMER, DAGER, H. S. PARKER, STONE, B. L.
PARKER, PEZAK, SHERMAN, BARBER, J. JOHNSON, DOYLE, KELLY,
E. B. DAVIS, FRANK, LUTTY, HUTCHINSON, ARTHURS, CROWLEY,
RAPPAPORT, RIEGER, KOWALYSHYN, MRS. TOLL, MESSRS. SCIRICA,
BERSON, WOJDAK, SCHMITT, ZELLER, MEHOLCHICK, MANDERINO,
HOVIS, EARLY, McMONAGLE, BENNETT, KLEPPER, DREIBELBIS,
PERRY, MORRIS, YAHNER, KLUNK, GLEESON, STEMMLER, NEEDHAM,
D. M. DAVIS, MEBUS, F. M. ALLEN, ZORD, HALVERSON, WRIGHT,
PIPER, WISE, HETRICK, PRENDERGAST, GELFAND, LAUDADIO,
BONETTO, SHELHAMER, KOLTER, R. O. DAVIS, HOPKINS,
WEIDNER AND LETTERMAN, MAY 3, 1971
REFERRED TO COMMITTEE ON HEALTH AND WELFARE, MAY 3, 1971
AN ACT
1 Relating to the manufacture, sale and possession of drugs,
2 devices and cosmetics; conferring powers on the courts and
3 the secretary and Department of Health and a newly created
4 Pennsylvania Drug, Device and Cosmetic Board; establishing
5 schedules of controlled drugs and dangerous substances;
6 providing penalties; requiring registration of persons
7 engaged in the drug trade and for the revocation or
8 suspension of certain licenses and registrations; and
9 repealing an act.
10 The General Assembly of the Commonwealth of Pennsylvania
11 hereby enacts as follows:
12 Section 1. Short Title.--This act shall be known and may be
13 cited as "The Drug, Device and Cosmetic Act of 1971."
14 Section 2. Definitions.--As used in this act:
1 (1) "Drug" means (i) articles recognized in the official
2 United States Pharmacopoeia, official Homeopathic Pharmacopoeia
3 of the United States, or official National Formulary, or any
4 supplement to any of them; and (ii) articles intended for use in
5 the diagnosis, cure, mitigation, treatment or prevention of
6 disease in man or other animals; and (iii) articles (other than
7 food) intended to affect the structure or any function of the
8 body of man or other animals; and (iv) articles intended for use
9 as a component of any article specified in clause (i), (ii) or
10 (iii), but not including devices or their components, parts or
11 accessories: Provided, That the drug provisions of this act
12 shall not apply to medicated feed intended for and used
13 exclusively as food for animals other than man: And provided
14 further, That the drug provisions as provided in this act shall
15 not apply to such vitamins, minerals and chemicals when used in
16 the processing and manufacture of foods and non-alcoholic
17 beverages specifically permitted under existing State and
18 Federal statutes as food and color additives. The term shall
19 include substances controlled by the secretary under the
20 provisions of sections 3 and 4 of this act.
21 (2) "Device" means instruments, apparatus and contrivances,
22 including their components, parts and accessories, intended (i)
23 for use in the diagnosis, cure, mitigation, treatment or
24 prevention of disease of man or other animals; or (ii) to affect
25 the structure or any function of the body of man or other
26 animals.
27 (3) "Cosmetic" means (i) articles intended to be rubbed,
28 poured, sprinkled or sprayed on, introduced into or otherwise
29 applied to the human body or any part thereof for cleansing,
30 beautifying, promoting attractiveness or altering the
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1 appearance, and (ii) articles intended for use as a component of
2 any such articles, except that such term shall not include soap.
3 (4) "Administer" means to transfer or deliver a controlled
4 drug or dangerous substance by a practitioner or his authorized
5 agent, in his presence, to an ultimate user or human research
6 subject by injection, or for inhalation or ingestion, or by any
7 other means involving the actual use of the drug.
8 (5) "Advertisement" means any representation, disseminated
9 in any manner or by any means other than by labeling, for the
10 purpose of inducing or which is likely to induce, directly or
11 indirectly, the purchase and/or use of a drug, device or
12 cosmetic.
13 (6) "Board" means the Pennsylvania Drug, Device and Cosmetic
14 Board.
15 (7) "Color additive" means a material which is a dye,
16 pigment or other substance made by a process of synthesis or
17 similar artifice, or extracted, isolated or otherwise derived,
18 with or without intermediate or final change of identity, from a
19 vegetable, animal, mineral or other source, and, when added or
20 applied to a drug or cosmetic or to the human body, is capable,
21 alone or through reaction with another substance, of imparting
22 color thereto, except that such term does not include any
23 material which the appropriate authority, pursuant to the
24 Federal act, determines is used or intended to be used solely
25 for a purpose or purposes other than coloring. The term "color"
26 includes black, white and intermediate grays.
27 (8) "Council" means the Governor's Council on Drug,
28 Narcotics and Alcohol Abuse.
29 (9) "Contaminated with filth" means consisting, in whole or
30 in part, of any decomposed, putrid or filthy substance, or
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1 prepared, packed or held under any unsanitary condition or
2 exposed whereby the article or product concerned may have become
3 contaminated with filth, dirt, dust or any foreign material, or
4 in any manner rendered injurious to health.
5 (10) "Contraband" means any controlled drug or dangerous
6 substance possessed by a person not authorized by law to possess
7 such drug or substance, or obtained or held in a manner contrary
8 to the provisions of this act.
9 (11) "Control" means to add, remove, or change the placement
10 of a drug, substance, or immediate precursor under the
11 provisions of sections 3 and 4 of this act.
12 (12) "Controlled dangerous substance" means a drug,
13 substance or immediate precursor in the schedules set forth in
14 section 4.
15 (13) "Controlled drug" includes:
16 (i) Any "narcotic drug" means any of the following, whether
17 produced directly or indirectly by extraction from substances of
18 vegetable origin, or independently by means of chemical
19 synthesis or by a combination of extraction and chemical
20 synthesis: (A) opium and coca leaves, (B) any opiate having an
21 addiction-forming or addiction-sustaining capacity similar to
22 morphine, (C) any compound, manufacture, salt, derivative, or
23 preparation of opium or coca leaves or any opiate, and (D) any
24 substance, and any compound, manufacture, salt, derivative, or
25 preparation thereof, which is chemically identical with any of
26 the substances referred to in (A), (B), or (C); except that it
27 shall not include decocainized coca leaves, or extracts of coca
28 leaves which do not contain cocaine or ecgonine;
29 (ii) "Marihuana" means all parts of the plant Cannabis,
30 sativa L., whether growing or not; the seeds thereof; the resin
19710H0851B0940 - 4 -
1 extracted from any part of such plant; and every compound,
2 manufacture, salt, derivative, mixture, or preparation of such
3 plant, its seeds, or resin; but shall not include the mature
4 stalks of such plant, fiber produced from such stalks, oil or
5 cake made from the seeds of such plant, any other compound,
6 manufacture, salt, derivative, mixture, or preparation of such
7 mature stalks (except the resin extracted therefrom), fiber,
8 oil, or cake, or the sterilized seeds of such plant which is
9 incapable of germination; and
10 (iii) "Depressant or stimulant drug" means: (A) a drug which
11 contains any quantity of barbituric acid or any of the salts of
12 barbituric acid; or any derivative of barbituric acid which has
13 been designated by the United States Secretary of Health,
14 Education, and Welfare as habit forming under subsection (d) of
15 section 502 of the "Federal Food, Drug, and Cosmetic Act" (52
16 Stat. 1050; 21 U.S.C. 352 (d)); (B) a drug which contains any
17 quantity of amphetamine or any of its optical isomers; or any
18 salt of amphetamine or any salt of any optical isomer of
19 amphetamine; or any substance which the secretary, after
20 investigation, has found to be, and by regulation designated as,
21 habit forming because of its stimulant effect on the central
22 nervous system; or (C) lysergic acid diethylamide or any other
23 drug which contains any quantity of a substance which the
24 secretary, after investigation, has found to have, and by
25 regulation designates as having, a potential for abuse because
26 of its depressant or stimulant effect on the central nervous
27 system or its hallucinogenic effect; but the term "controlled
28 drug" shall not include any drug specifically exempted by a
29 regulation promulgated by the secretary as not dangerous to the
30 public health and welfare. Except as otherwise provided herein,
19710H0851B0940 - 5 -
1 the term shall include dangerous substances controlled by the
2 secretary under sections 3 and 4 of this act.
3 (14) "Controlled paraphernalia" includes:
4 (i) a hypodermic syringe, needle or other instrument or
5 implement or combination thereof adapted for the administration
6 of controlled substances by intravenous injections or otherwise
7 under circumstances, including but not limited to, the close
8 proximity to other controlled paraphernalia, which reasonably
9 indicate an intention to use or possess such controlled
10 paraphernalia for purposes of unlawfully administering any
11 controlled substance;
12 (ii) diluents, dilutants or adulterants, including but not
13 limited to, any of the following: quinine hydrochloride,
14 mannitol, mannite, lactose or dextrose, adapted for the dilution
15 of controlled substances under circumstances, including, but not
16 limited to, the close proximity to other controlled
17 paraphernalia, which reasonably indicate an intention to use or
18 possess such controlled paraphernalia for purposes of unlawfully
19 diluting or processing any controlled substance; and
20 (iii) gelatin capsules, glassine envelopes or any other
21 material suitable for the packaging of individual quantities of
22 controlled substances under circumstances, including but not
23 limited to, the close proximity to other controlled
24 paraphernalia, which reasonably indicate an intention to use or
25 possess any such item for the unlawful manufacture, distribution
26 or dispensing of any such controlled substance.
27 (15) "Counterfeit drug" means a drug or controlled dangerous
28 substance which, or the container or labeling of which, without
29 authorization, bears the trademark, trade name, or other
30 identifying mark, imprint, number, or device, or any likeness
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1 thereof, of a manufacturer, distributor, or dispenser other than
2 the person or persons who in fact manufactured, distributed, or
3 dispensed such substance and which thereby falsely purports or
4 is represented to be the product of, or to have been distributed
5 by, such other manufacturer, distributor, or dispenser.
6 (16) "Dispense" means to transfer or deliver a drug or
7 controlled dangerous substance to an ultimate user or human
8 research subject by, or pursuant to the lawful order of, a
9 practitioner.
10 (17) The term "immediate container" does not include package
11 liners.
12 (18) "Immediate precursor" means a substance which the board
13 has found to be and by regulation designates as being the
14 principal compound commonly used or produced primarily for use,
15 and which is an immediate chemical intermediary used or likely
16 to be used in the manufacture of a controlled dangerous
17 substance, the control of which is necessary to prevent,
18 curtail, or limit such manufacture.
19 (19) "Label" means a display of written, printed or graphic
20 matter upon the immediate container of any article, and a
21 requirement made by or under authority of this act that any
22 word, statement or other information appearing on the label
23 shall not be considered to be complied with unless such word
24 statement or other information also appears on the outside
25 container or wrapper, if any there be, of the retail package of
26 such article or is easily legible through the outside container
27 or wrapper.
28 (20) "Labeling" means all labels and other written, printed,
29 or graphic matter (i) upon an article or any of its containers
30 or wrappers, or (ii) accompanying such article.
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1 (21) "Manufacture" means the production, preparation,
2 propagation, compounding, or processing of a drug or controlled
3 dangerous substance, either directly or indirectly by extraction
4 from substances of natural origin, or independently by means of
5 chemical synthesis or by a combination of extraction and
6 chemical synthesis. "Manufacturer" also includes any person who
7 packages, repackages, or labels any container of any drug or
8 controlled dangerous substance, except practitioners who
9 dispense or compound prescription order for delivery to the
10 ultimate consumer.
11 (22) "New drug" means (i) any drug the composition of which
12 is such that such drug is not generally recognized among experts
13 qualified by scientific training and experience to evaluate the
14 safety and effectiveness of drugs as safe and effective for use
15 under the conditions prescribed, recommended or suggested in the
16 labeling thereof; or (ii) any drug the composition of which is
17 such that such drug, as a result of investigations to determine
18 its safety and effectiveness for use under such conditions, has
19 become so recognized, but which has not, otherwise than in such
20 investigations, been used to a material extent or for a material
21 time under such conditions.
22 (23) "Nonproprietary drug" means any drug containing any
23 quantity of any narcotic drug, a drug containing biologicals or
24 substances of glandular origin (except intestinal enzymes and
25 all liver products), drugs which are administered
26 hypodermically, intramuscularly or intravenously, but not any
27 such drugs which are prepackaged with complete dosage
28 instructions in the labeling limiting their use to the care or
29 treatment of poultry and livestock.
30 (24) "Official compendium" means the official United States
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1 Pharmacopoeia, official Homeopathic Pharmacopoeia of the United
2 States, official National Formulary or any supplement to any of
3 them.
4 (25) "Opiate" means any substance having an addiction-
5 forming or addiction-sustaining liability similar to morphine or
6 being capable of conversion into a drug having such addiction-
7 forming or addiction-sustaining liability.
8 (26) "Opium poppy" means the plant of the species Papaver
9 somniferum L., except the seeds thereof.
10 (27) "Person" means any individual, partnership,
11 corporation, association, trust, or other institution or entity.
12 (28) "Poppy straw" means all parts, except the seeds, of the
13 opium poppy, after mowing.
14 (29) "Possess" means to exercise dominion or control over a
15 drug or controlled dangerous substance.
16 (30) "Practitioner" means a physician, including an intern
17 and resident, dentist, veterinarian, scientific investigator,
18 pharmacist, pharmacy, hospital, clinic, or other person
19 licensed, registered, or otherwise authorized or allowed by the
20 Commonwealth of Pennsylvania to distribute, dispense, conduct
21 research with respect to or administer a drug or controlled
22 dangerous substance in the course of professional practice or
23 research.
24 (31) "Production" includes the manufacture, planting,
25 cultivation, growing, or harvesting of a controlled dangerous
26 substance.
27 (32) "Registrant" means any person registered under the laws
28 of this Commonwealth to manufacture, dispense, administer or
29 sell drugs.
30 (33) "Secretary" means the Secretary of Health of the
19710H0851B0940 - 9 -
1 Commonwealth of Pennsylvania.
2 (34) "Ultimate user" means any person who possesses a drug
3 or controlled dangerous substance for his own use or for the use
4 of a member of his household or for administration to an animal
5 owned by him or by a member of his household.
6 (35) "Wholesaler" means any person engaged in the activities
7 of jobber, dealer, repackager or wholesaler, selling,
8 repackaging or otherwise distributing any drug or controlled
9 dangerous substance for resale or redistribution which he has
10 not himself prepared, produced or compounded.
11 Section 3. Authority to Control.--(a) The secretary shall
12 control all substances enumerated in section 4 of this act and
13 may, upon his own motion or on the petition of any interested
14 party add, delete, or reschedule a substance as a controlled
15 dangerous substance. Before so doing, the secretary shall
16 request the advice in writing from the Governor's Council on
17 Drug, Narcotics and Alcohol Abuse whether a substance should be
18 added, deleted, or rescheduled as a controlled dangerous
19 substance. Such advice shall be rendered to the secretary within
20 a reasonable time. The secretary shall consider with respect to
21 each substance hereafter controlled:
22 (1) Its actual or relative potential for abuse;
23 (2) Scientific evidence of its pharmacological effect, if
24 known;
25 (3) State of current scientific knowledge regarding the
26 substance;
27 (4) Its history and current pattern of abuse;
28 (5) The scope, duration, and significance of abuse;
29 (6) What, if any, risk there is to the public health;
30 (7) Its psychic or physiological dependence liability;
19710H0851B0940 - 10 -
1 (8) Whether the substance is controlled under Federal law;
2 and
3 (9) Whether the substance is an immediate precursor of a
4 substance already controlled under this section. After
5 considering the above factors, the secretary shall make findings
6 with respect thereto and shall issue an order controlling the
7 substance if he finds that the substance has a potential for
8 abuse.
9 (b) If the secretary designates a substance as an immediate
10 precursor, substances which are precursors of the controlled
11 precursor shall not be subject to control solely because they
12 are precursors of the controlled precursor.
13 (c) When, for the purpose of greater protection of the
14 public, at the time a new drug application is submitted to the
15 board for any drug having a stimulant, depressant, or
16 hallucinogenic effect on the central nervous system, it appears
17 that such drug has an abuse potential such information shall be
18 submitted to review by the Scientific Advisory Committee of the
19 Board prior to their advising the secretary whether or not to
20 control such drug under this act.
21 (d) The secretary shall not remove any Schedule I substance
22 of section 4 of this act to Schedules III, IV or V of such
23 section, nor shall he delete such substances from the controls
24 of this act unless specifically authorized by the General
25 Assembly to do so.
26 Section 4. Schedules of Controlled Substances.--The
27 following schedules include the controlled dangerous substances
28 listed or to be listed by whatever official name, common or
29 usual name, chemical name, or trade name designated.
30 (1) Schedule I--In determining that a substance comes within
19710H0851B0940 - 11 -
1 this schedule, the secretary shall find: a high potential for
2 abuse, no currently accepted medical use in the United States,
3 and a lack of accepted safety for use under medical supervision.
4 The following controlled dangerous substances are included in
5 this schedule:
6 (i) Any of the following opiates, including their isomers,
7 esters, ethers, salts, and salts of isomers, esters, and ethers,
8 unless specifically excepted, whenever the existence of such
9 isomers, esters, ethers and salts is possible within the
10 specific chemical designation:
11 1. Acetylmethadol.
12 2. Allylprodine.
13 3. Alphacteylmethadol.
14 4. Alphameprodine.
15 5. Alphamethadol.
16 6. Benzethidine.
17 7. Betacetylmethadol.
18 8. Betameprodine.
19 9. Betamethadol.
20 10. Betaprodine.
21 11. Clonitazene.
22 12. Dextromoramide.
23 13. Dextrorphan (except its methylether).
24 14. Diampromide.
25 15. Diethyliambutene.
26 16. Dimenoxadol.
27 17. Dimepheptanol.
28 18. Dimethyliambutene.
29 19. Dioxaphetyl butyrate.
30 20. Dipipanone.
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1 21. Ethylmethylthiambutene.
2 22. Etonitazene.
3 23. Etoxeridine.
4 24. Furethidine.
5 25. Hydroxypethidine.
6 26. Ketobemidone.
7 27. Levomoramide.
8 28. Levophenacylmorphan.
9 29. Morpheridine.
10 30. Noracymethadol.
11 31. Norlevorphanol.
12 32. Normethadone.
13 33. Norpipanone.
14 34. Phenadoxone.
15 35. Phenampromide.
16 36. Phenomorphan.
17 37. Phenoperidine.
18 38. Piritramide.
19 39. Proheptazine.
20 40. Properidine.
21 41. Racemoramide.
22 42. Trimeperidine.
23 (ii) Any of the following opium derivatives, their salts,
24 isomers and salts of isomers, unless specifically excepted,
25 whenever the existence of such salts, isomers and salts of
26 isomers is possible within the specific chemical designation:
27 1. Acetorphine.
28 2. Acetyldihydrocodeine.
29 3. Benzylmorphine.
30 4. Codeine Methylbromide.
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1 5. Codeine-N-Oxide.
2 6. Cyprenorphine.
3 7. Desomorphine.
4 8. Dihydromorphine.
5 9. Etorphine.
6 10. Heroin.
7 11. Hydromorphinol.
8 12. Methyldesorphine.
9 13. Methylhydromorphine.
10 14. Morphine methylbromide.
11 15. Morphine methylsulfonate.
12 16. Morphine-N-Oxide.
13 17. Myrophine.
14 18. Nicocodeine.
15 19. Nicomorphine.
16 20. Normorphine.
17 21. Pholcodine.
18 22. Thebacon.
19 (iii) Any material, compound, mixture, or preparation which
20 contains any quantity of the following hallucinogenic
21 substances, their salts, isomers, and salts of isomers, unless
22 specifically excepted, whenever the existence of such salts,
23 isomers, and salts of isomers is possible within the specific
24 chemical designation:
25 1. 3,4-methylenedioxy amphetamine.
26 2. 5-methoxy-3,4-methylenedioxy amphetamine.
27 3. 3,4,5-trimethoxy amphetamine.
28 4. Bufotenine.
29 5. Diethyltryptamine.
30 6. Dimethyltryptamine.
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1 7. 4-methyl-2,5-dimethoxyamphetamine.
2 8. Ibogaine.
3 9. Lysergic acid diethylamide.
4 10. Marihuana.
5 11. Mescaline.
6 12. Peyote.
7 13. N-ethyl-3-piperidyl benzilate.
8 14. N-methyl-3-piperidyl benzilate.
9 15. Psilocybin.
10 16. Psilocyn.
11 17. Tetrahydrocannabinois.
12 (2) Schedule II--In determining that a substance comes
13 within this schedule, the secretary shall find: a high potential
14 for abuse, currently accepted medical use in the United States,
15 or currently accepted medical use with severe restrictions, and
16 abuse may lead to severe psychic or physical dependence. The
17 following controlled dangerous substances are included in this
18 schedule:
19 (i) Any of the following substances except those narcotic
20 drugs specifically excepted or listed in other schedules,
21 whether produced directly or indirectly by extraction from
22 substances of vegetable origin, or independently by means of
23 chemical synthesis, or by combination of extraction and chemical
24 synthesis:
25 1. Opium and opiate, and any salt, compound, derivative, or
26 preparation of opium or opiate.
27 2. Any salt, compound, derivative, or preparation thereof
28 which is chemically equivalent or identical with any of the
29 substances referred to in subclause 1, except that these
30 substances shall not include the isoquinoline alkaloids of
19710H0851B0940 - 15 -
1 opium.
2 3. Opium poppy and poppy straw.
3 4. Coca leaves and any salt, compound, derivative, or
4 preparation of coca leaves, and any salt, compound, derivative,
5 or preparation thereof which is chemically equivalent or
6 identical with any of these substances, except that the
7 substances shall not include decocainized coca leaves or
8 extraction of coca leaves, which extractions do not contain
9 cocaine or ecgonine.
10 (ii) Any of the following opiates, including their isomers,
11 esters, ethers, salts, and salts of isomers, esters and ethers,
12 unless specifically excepted, whenever the existence of such
13 isomers, esters, ethers and salts is possible within the
14 specific chemical designation:
15 1. Alphaprodine.
16 2. Anileridine.
17 3. Bezitramide.
18 4. Dihydrocodeine.
19 5. Diphenoxylate.
20 6. Fentanyl.
21 7. Isomethadone.
22 8. Levomethorphan.
23 9. Levorphanol.
24 10. Metazocine.
25 11. Methadone.
26 12. Methadone-Intermediate, 4-cyano-2-dimethylamino-4,4-
27 diphenyl butane.
28 13. Moramide-Intermediate, 2-methyl-3-morpholino-1, 1-
29 diphenyl-propane-carboxylic acid.
30 14. Pethidine.
19710H0851B0940 - 16 -
1 15. Pethidine-Intermediate-A, 4-cyano-1-methyl-4-
2 phenylpiperidine.
3 16. Pethidine-Intermediate-B, ethyl-4-phenylpiperidine-4-
4 carboxylate.
5 17. Pethidine-Intermediate-C, 1-methyl-4-phenylpiperidine-4-
6 carboxylic acid.
7 18. Phenazocine.
8 19. Piminodine.
9 20. Racemethorphan.
10 21. Racemorphan.
11 (iii) Unless specifically excepted or unless listed in
12 another schedule, any injectable liquid which contains any
13 quantity of methamphetamine, including its salts, isomers, and
14 salts of isomers.
15 (iv) The phrase "opiates" as used in section 4 of this act
16 and elsewhere throughout the act shall not include the
17 dextrorotatory isomer of 3-methoxy-n-methylmorphinan and its
18 salts, but does include its racemic and levorotatory forms.
19 (3) Schedule III--In determining that a substance comes
20 within this schedule, the secretary shall find: a potential for
21 abuse less than the substances listed in Schedules I and II;
22 well documented and currently accepted medical use in the United
23 States; and abuse may lead to moderate or low physical
24 dependence or high psychological dependence. The following
25 classes of controlled dangerous substances are included in this
26 schedule:
27 (i) Any material, compound, mixture, or preparation unless
28 specifically excepted or unless listed in another schedule which
29 contains any quantity of the following substances having a
30 potential for abuse associated with a stimulant effect on the
19710H0851B0940 - 17 -
1 central nervous system:
2 1. Amphetamine, its salts, optical isomers, and salts of its
3 optical isomers.
4 2. Phenmetrazine and its salts.
5 3. Any substance which contains any quantity of
6 methamphetamine, including its salts, isomers, and salts of
7 isomers.
8 4. Methylphenidate.
9 (ii) Any material, compound, mixture, or preparation unless
10 specifically excepted or unless listed in another schedule which
11 contains any quantity of the following substances having a
12 potential for abuse associated with a depressant effect on the
13 central nervous system:
14 1. Any substance which contains any quantity of a derivative
15 of barbituric acid, or any salt of a derivative of barbituric
16 acid.
17 2. Chorhexadol.
18 3. Glutethimide.
19 4. Lysergic acid.
20 5. Lysergic acid amide.
21 6. Methyprylon.
22 7. Phencyclidine.
23 8. Sulfondiethylmethane.
24 9. Sulfonethylmethane.
25 10. Sulfonmethane.
26 (iii) Nalorphine.
27 (iv) Any material, compound, mixture, or preparation
28 containing limited quantities of any of the following narcotic
29 drugs, or any salts thereof, except those narcotic drugs
30 specifically excepted or listed in other schedules:
19710H0851B0940 - 18 -
1 1. Not more than one and eighty one-hundredths grams of
2 codeine per one hundred milliliters or not more than ninety
3 milligrams per dosage unit, with an equal or greater quantity of
4 an isoquinoline alkaloid of opium.
5 2. Not more than one and eighty one-hundredths grams of
6 codeine per one hundred milliliters or not more than ninety
7 milligrams per dosage unit, with one or more active, nonnarcotic
8 ingredients in recognized therapeutic amounts.
9 3. Not more than three hundred milligrams of
10 dihydrocodeinone per one hundred milliliters or not more than
11 fifteen milligrams per dosage unit, with a fourfold or greater
12 quantity of an isoquinoline alkaloid of opium.
13 4. Not more than three hundred milligrams of
14 dihydrocodeinone per one hundred milliliters or not more than
15 fifteen milligrams per dosage unit, with one or more active,
16 nonnarcotic ingredients in recognized therapeutic amounts.
17 5. Not more than one and eighty one-hundredths grams of
18 dihydrocodeine per one hundred milliliters or not more than
19 ninety milligrams per dosage unit, with one or more active,
20 nonnarcotic ingredients in recognized therapeutic amounts.
21 6. Not more than three hundred milligrams of ethylmorphine
22 per one hundred milliliters or not more than fifteen milligrams
23 per dosage unit, with one or more active, nonnarcotic
24 ingredients in recognized therapeutic amounts.
25 7. Not more than five hundred milligrams of opium per one
26 hundred milliliters or per one hundred grams, or not more than
27 twenty-five milligrams per dosage unit, with one or more active,
28 nonnarcotic ingredients in recognized therapeutic amounts.
29 8. Not more than fifty milligrams of morphine per one
30 hundred milliliters or per one hundred grams with one or more
19710H0851B0940 - 19 -
1 active, nonnarcotic ingredients in recognized therapeutic
2 amounts.
3 (v) The secretary may by regulation except any compound,
4 mixture, or preparation containing any drug or controlled
5 dangerous substance listed in subclauses (i) and (ii) of this
6 schedule above from the application of those provisions of this
7 act covering controlled drugs, if the compound, mixture, or
8 preparation contains one or more active medicinal ingredients
9 not having a stimulant or depressant effect on the central
10 nervous system: Provided, That such admixtures shall be included
11 therein in such combinations, quantity, proportion, or
12 concentration as to vitiate the potential for abuse of the
13 substances which do have a stimulant or depressant effect on the
14 central nervous system.
15 (vi) The secretary shall by regulation exempt any
16 nonnarcotic substance from the control under this act if such
17 substance may, under the provisions of the Federal Food, Drug,
18 and Cosmetic Act (21 U.S.C. 301 et seq.), be lawfully sold over
19 the counter without a prescription.
20 (4) Schedule IV--Any material, compound, mixture, or
21 preparation, unless specifically excepted or unless listed in
22 another schedule, which contains any quantity of the following
23 substances having a potential for abuse associated with a
24 depressant effect on the central nervous system:
25 1. Barbital.
26 2. Chloral betaine.
27 3. Chloral hydrate.
28 4. Ethchlorvynol.
29 5. Ethinamate.
30 6. Methohexital.
19710H0851B0940 - 20 -
1 7. Meprobamate.
2 8. Methylphenobarbital.
3 9. Paraldehyde.
4 10. Petrichloral.
5 11. Phenobarbital.
6 (5) Schedule V--In determining that a substance comes within
7 this schedule, the secretary shall find: a low potential for
8 abuse relative to the substances listed in Schedule IV;
9 currently accepted medical use in the United States; and limited
10 physical dependence and/or psychological dependence liability
11 relative to the substances listed in Schedule IV. The following
12 controlled dangerous substances are included in this schedule:
13 (i) Any compound, mixture, or preparation containing limited
14 quantities of any of the following narcotic drugs, which shall
15 include one or more nonnarcotic active medicinal ingredients in
16 sufficient proportion to confer upon the compound, mixture, or
17 preparation, valuable medicinal qualities other than those
18 possessed by the narcotic drug alone:
19 1. Not more than two hundred milligrams of codeine per one
20 hundred milliliter or per one hundred grams.
21 2. Not more than one hundred milligrams of dihydrocodeine
22 per one hundred milliliters or per one hundred grams.
23 3. Not more than fifty milligrams of ethylmorphine per one
24 hundred milliliters or per one hundred grams.
25 4. Not more than two and five-tenths milligrams of
26 diphenoxylate and not less than twenty-five micrograms of
27 atropine sulfate per dosage unit.
28 5. Not more than one hundred milligrams of opium per one
29 hundred milliliters or per one hundred grams, or not more than
30 five milligrams per dosage unit.
19710H0851B0940 - 21 -
1 Section 5. Exempt Substances and Drugs.--(a) In accordance
2 with the provisions of section 3, the secretary, after
3 consultation and upon the recommendation of the board, may, by
4 regulation, exempt, from the provisions of this act relating to
5 controlled dangerous substances or drugs to such extent as he
6 determines to be consistent with the public welfare, substances
7 and drugs found by the secretary:
8 (1) Either to possess no addiction-forming or addiction-
9 sustaining liability or not to possess an addiction-forming or
10 addiction-sustaining liability sufficient to warrant imposition
11 of all of the requirements of this act; and
12 (2) Not to permit recovery of a controlled dangerous
13 substance or drug having such an addiction-forming or addiction-
14 sustaining liability with such relative technical simplicity and
15 degree of yield as to create a risk of improper use.
16 (b) In exercising the authority granted in subsection (a),
17 the secretary, by regulations and without special findings,
18 shall, unless cogent reasons require otherwise in the interest
19 of public health, grant exempt status to such substances and
20 drugs as are determined to be exempt under the Federal narcotic
21 law and regulations and the Federal law and regulations
22 pertaining to controlled drugs and dangerous substances.
23 (c) If the secretary shall subsequently determine that any
24 exempt substance or drug does possess a degree of addiction
25 liability that results in abusive use, he shall, by regulation,
26 remove such substance or drug from exempt status effective on a
27 date fixed by the regulation.
28 Section 6. Registration.--(a) No person shall operate within
29 this Commonwealth as a manufacturer, wholesaler or retailer of
30 drugs or devices nor sell, offer for sale nor solicit the
19710H0851B0940 - 22 -
1 purchase of drugs or devices nor hold drugs or devices for sale
2 or resale until such person has registered under this act with
3 the secretary.
4 (1) Any manufacturer or wholesaler not operating an
5 establishment within this Commonwealth, but employing sales
6 representatives or detailmen within this Commonwealth, shall
7 either register as a manufacturer, or wholesaler as the case may
8 be, or file, in lieu of registration, with the secretary the
9 names and addresses of such representatives and detailmen, and
10 shall promptly inform the secretary of any changes in said list.
11 (2) Separate registration with the secretary shall be
12 required for each place at which such person carries on
13 activities as a manufacturer, wholesaler or retailer within this
14 Commonwealth. The certificate evidencing such registration shall
15 be conspicuously displayed and shall not be transferable.
16 (3) Certificates of registration issued by the State Board
17 of Pharmacy or under the law preceding this act to manufacturers
18 shall continue to be valid for the period issued and, upon
19 expiration, shall be renewed in the manner provided for renewal
20 of certificates of registration issued pursuant to this section.
21 Nothing contained herein shall be construed to require the
22 registration hereunder of pharmacists registered by the Board of
23 Pharmacy nor pharmacies licensed by said board, nor to require
24 the separate registration of agents or employes of persons
25 registered pursuant to the provisions of this section, or of
26 sales representatives or detailmen of manufacturers or
27 wholesalers nor operating an establishment within this
28 Commonwealth whose names and addresses are on file with the
29 secretary: Provided, however, That all persons registered
30 pursuant to this section, whether located within this
19710H0851B0940 - 23 -
1 Commonwealth or not, shall be deemed to have accepted and shall
2 be subject to all provisions of this act.
3 (b) No person shall operate as a manufacturer of drugs or
4 devices unless such drugs or devices are manufactured under the
5 supervision of a registered pharmacist, chemist or other person
6 possessing at least five years' experience in the manufacture of
7 drugs or devices or such other person approved by the secretary
8 as qualified by scientific or technical training or experience
9 to perform such duties of supervision as may be necessary to
10 protect the public health and safety.
11 (c) Each application for registration as a manufacturer
12 shall be accompanied by a fee of one hundred dollars ($100).
13 Each application for registration as a wholesaler shall be
14 accompanied by a fee of twenty-five dollars ($25). Each
15 application for registration as a retailer shall be accompanied
16 by a fee of two dollars ($2). Applications shall be on forms
17 prescribed by the secretary. Registration certificates shall be
18 renewed annually and applications therefor shall be accompanied
19 by the same fee as for initial applications.
20 (d) Registration shall become effective at noon on the
21 sixtieth day after application therefor is filed: Provided,
22 however, That the secretary shall have authority to issue a
23 registration certificate or to issue an order denying such
24 registration pursuant to subsection (e) hereof at any time prior
25 to the expiration of such sixty day period. Renewal of
26 registration shall be effective upon application.
27 (e) The secretary may refuse the initial registration (i) of
28 any person who has made false representation in the application
29 for registration, or of any person or agent or employe of any
30 person who manufactures drugs or devices other than under the
19710H0851B0940 - 24 -
1 supervision of a registered pharmacist, chemist or other person
2 possessing at least five years' experience in the manufacture of
3 said drugs or devices, or such person approved by the secretary
4 as provided herein, or who fails to comply with the standards of
5 sanitation, equipment, materials or supplies promulgated
6 pursuant to the provisions of this act, until such person has
7 filed a proper application and is in compliance with this
8 section and with said standards of sanitation, equipment,
9 materials and supplies; and (ii) in addition to the foregoing,
10 of any manufacturer or wholesaler, (A) who has been convicted of
11 a violation of any law of this Commonwealth or of the United
12 States relating to the sale, use or possession of narcotic drugs
13 if such refusal shall be necessary for the protection of the
14 public health and safety, or (B) who knowingly employs in any
15 capacity connected with the preparation, handling or sale of
16 narcotic drugs any person convicted of a violation of the laws
17 of this Commonwealth or of the United States relating to the
18 sale, use or possession of narcotics, unless prior consent shall
19 have been obtained from the secretary.
20 (f) In addition to all other penalties provided for
21 violations of this act, the secretary may, after notice and
22 hearing pursuant to the Administrative Agency Law as amended,
23 (i) in the case of a manufacturer registered hereunder, prohibit
24 the sale in Pennsylvania of any drugs or devices involved in any
25 violation of this act which he commits with knowledge or reason
26 to know of said violation, (ii) suspend or revoke the
27 registration of any manufacturer if said registrant, (A) makes
28 any sale in Pennsylvania of any drug or device whose sale has
29 been prohibited under the preceding clause, or (B) is convicted
30 of a violation of any law of this Commonwealth or of the United
19710H0851B0940 - 25 -
1 States relating to the sale, use or possession of drugs or
2 controlled substances if such suspension or revocation shall be
3 necessary for the protection of the public health and safety,
4 (C) knowingly employs in any capacity connected with the
5 preparation, handling or sale of drugs or controlled substances
6 any person convicted of a violation of the laws of this
7 Commonwealth or of the United States relating to the sale, use
8 or possession of drugs or controlled substances unless prior
9 consent shall have been obtained from the secretary, (iii) in
10 the case of a wholesaler registered hereunder, suspend or revoke
11 his registration for any violation of this act which he commits
12 with knowledge or reason to know of said violation if such
13 suspension or revocation shall be necessary for the protection
14 of the public health and safety.
15 (g) If the secretary takes any action refusing registration
16 or disciplining any registrant under subsections (e) and (f),
17 the aggrieved party may, within fifteen days after the date upon
18 which a copy of the order is delivered to the address indicated
19 on the application or the registration certificate, whichever is
20 applicable, petition the board for review. The board shall,
21 within thirty days, grant a hearing and, as soon thereafter as
22 practicable, adopt, modify or reject the action of the
23 secretary. Any action by the board shall be deemed an
24 adjudication to which the provisions of the Administrative
25 Agency Law, as amended, shall be applicable.
26 Section 7. Adulteration.--A drug or device or cosmetic shall
27 be deemed to be adulterated:
28 (1) (i) If it consists, in whole or in part, of any filthy,
29 putrid or decomposed substance; (ii) if it has been prepared,
30 packed or held under conditions whereby it may have been
19710H0851B0940 - 26 -
1 contaminated with filth, or whereby it may have been rendered
2 injurious to health; (iii) if its container is composed, in
3 whole or in part, of any poisonous or deleterious substance
4 which may render the contents injurious to health; (iv) if it
5 has been exposed to conditions of fire, water or extreme
6 temperature, which may have rendered it injurious to health; (v)
7 if (A) it bears or contains for purposes of coloring only a
8 color additive, unless it be a hair dye which is unsafe within
9 the meaning of section 9 of this act, or (B) it is a color
10 additive the intended use of which in or on drugs, devices or
11 cosmetics is for purposes of coloring only and is unsafe, unless
12 it be a hair dye within the meaning of section 9 of this act.
13 (2) If it purports to be or is represented as a drug, the
14 name of which is recognized in an official compendium and its
15 strength differs from or its quality or purity falls below the
16 standards set forth in such compendium. Such determination as to
17 strength, quality or purity, shall be made in accordance with
18 the tests or methods of assay set forth in such compendium, or
19 in the absence of or inadequacy of such tests or methods of
20 assay those prescribed under the authority of the Federal act.
21 No drug defined in an official compendium shall be deemed to be
22 adulterated under this subsection because it differs from the
23 standard of strength, quality or purity therefor set forth in
24 such compendium, if its difference in strength, quality or
25 purity from such standard is plainly stated on its label.
26 Whenever a drug is recognized in both the United States
27 Pharmacopoeia and the Homeopathic Pharmacopoeia of the United
28 States, it shall be subject to the requirements of the United
29 States Pharmacopoeia unless it is labeled and offered for sale
30 as a homeopathic drug, in which case, it shall be subject to the
19710H0851B0940 - 27 -
1 provisions of the Homeopathic Pharmacopoeia of the United States
2 and not to those of the United States Pharmacopoeia.
3 (3) If it is a color additive and is to be used or is
4 recommended for use as a hair dye and it is not exempt under
5 section 9 unless its label bears the following legend
6 conspicuously displayed thereon: "Caution. This product contains
7 ingredients which may cause skin irritation on certain
8 individuals and a preliminary test according to accompanying
9 directions should first be made. This product must not be used
10 for dyeing the eyelashes or eyebrows, to do so may cause
11 blindness," and the labeling bears adequate directions for such
12 preliminary testing. For the purpose of this paragraph, the term
13 "hair dye" shall not include eyelash dyes or eyebrow dyes.
14 (4) If it is not subject to the provisions of clause (2) of
15 this section and its strength differs from or its purity or
16 quality falls below that which it purports or is represented to
17 possess.
18 (5) If it is a drug and any substance has been (i) mixed or
19 packed therewith so as to reduce its quality or strength, or
20 (ii) substituted wholly or in part therefor.
21 Section 8. Misbranding.--A drug or device or cosmetic shall
22 be deemed to be misbranded:
23 (1) If its labeling is false or misleading in any
24 particular.
25 (2) If in package form unless it bears a label containing
26 (i) the name and place of business of the manufacturer, packer
27 or distributor, and (ii) an accurate statement of the quantity
28 of the contents in terms of weight measure or numerical count:
29 Provided, That under subclause (ii) of this clause, reasonable
30 variations shall be permitted and exemptions as to small
19710H0851B0940 - 28 -
1 packages shall be established by regulations.
2 (3) If any word, statement or other information required by
3 or under authority of this act to appear on the label, or
4 labeling is not prominently placed thereon with such
5 conspicuousness (as compared with other words, statements,
6 designs or devices in the labeling), and in such terms as to
7 render it likely to be read and understood by the ordinary
8 individual under customary conditions of purchase and use.
9 (4) If it is for use by man and is a narcotic, depressant or
10 stimulant drug designated as habit-forming, unless its label
11 bears the name and quantity or proportion of such substance or
12 derivative and if required by applicable Federal law or
13 regulations, in juxtaposition therewith the statement "Warning.
14 May Be Habit-Forming."
15 (5) If it is a drug and is not designated solely by a name
16 recognized in an official compendium, unless its label bears (i)
17 the common or usual name of the drug, if such there be, and (ii)
18 in case it is fabricated from two or more ingredients, the
19 common or usual name of each active ingredient including the
20 kind and quantity or proportion of any alcohol and also
21 including whether active or not, the name and quantity or
22 proportion of any bromides, ether, chloroform, acetanilid,
23 acetphenetidin, amidopyrine, antipyrine, atropine, hyoscine,
24 hyoscyamine, arsenic, digitalis, glucosides, mercury, ouabain,
25 strophanthin, strychnine, thyroid or any derivative or
26 preparation of any such substances contained therein: Provided,
27 That to the extent that compliance with the requirements of
28 subclause (ii) of this clause is impracticable, exemptions shall
29 be established by regulations.
30 (6) Unless its labeling bears (i) adequate directions for
19710H0851B0940 - 29 -
1 use, and (ii) such adequate warnings against use in those
2 pathological conditions or by children where its use may be
3 dangerous to health or against unsafe dosage or methods or
4 duration of administration or application in such manner and
5 form as are necessary for the protection of users: Provided,
6 That where any requirement of subclause (i) of this clause as
7 applied to any drug or device is not necessary for the
8 protection of the public health, regulations shall be
9 promulgated exempting such drug or device or cosmetic from such
10 requirements.
11 (7) If it purports to be a drug, the name of which is
12 recognized in an official compendium, unless it is packaged and
13 labeled as prescribed therein: Provided, That the method of
14 packing may be modified with a consent of the secretary.
15 Whenever a drug is recognized in both the United States
16 Pharmacopoeia and the Homeopathic Pharmacopoeia of the United
17 States, it shall be subject to the requirements of the United
18 States Pharmacopoeia with respect to packaging and labeling,
19 unless it is labeled and offered for sale as a homeopathic drug,
20 in which case, it shall be subject to the provisions of the
21 Homeopathic Pharmacopoeia of the United States and not to those
22 of the United States Pharmacopoeia.
23 (8) If it has been found by the secretary to be a drug
24 liable to deterioration unless it is packaged in such form and
25 manner and its label bears a statement specifying such
26 precautions against deterioration as the secretary shall by
27 regulation require as necessary for the protection of public
28 health. No such regulation shall be established for any drug
29 recognized in an official compendium, or for any drug which
30 regulations specifying precautions against deterioration have
19710H0851B0940 - 30 -
1 been promulgated by the Secretary of Health, Education and
2 Welfare under the Federal act.
3 (9) If it is offered for sale or sold under the name of
4 another drug, device or cosmetic or brand of drug, device or
5 cosmetic, or if it is manufactured, packaged, labeled or sold in
6 such manner as to give rise to a reasonable probability that the
7 purchaser will be led to believe he is purchasing such drug,
8 device or cosmetic as another drug, device or cosmetic or as the
9 product of another manufacturer.
10 (10) If it is dangerous to health when used in the dosage or
11 with the frequency or duration prescribed, recommended or
12 suggested in the labeling thereof.
13 (11) A drug dispensed by filling or refilling a written or
14 oral prescription issued by a person licensed by law to
15 administer or prescribe such drug (except a drug sold in the
16 course of the conduct of a business of selling drugs pursuant to
17 diagnosis by mail) shall be exempt from the requirements of this
18 section, except clauses (1) and (9) if such drug bears a label
19 containing the name and place of business of the dispenser, the
20 serial number and date of such prescription, the name and
21 address of the person prescribing such drug, the name and
22 address of the patient and such directions for use and
23 cautionary statements, if any, contained in such prescription.
24 (12) If it is a cosmetic and its container is so made,
25 formed or filled as to be misleading.
26 Section 9. Color Additives.--A color additive shall be
27 deemed unsafe unless there is in effect with respect to such
28 additive a regulation issued pursuant to the Federal act
29 permitting such use and unless such additive and use thereof
30 conforms in all respects to the requirements of the Federal act
19710H0851B0940 - 31 -
1 and regulations issued pursuant thereto.
2 Section 10. New Drugs.--(a) No person shall sell, deliver,
3 offer for sale, hold for sale, or give away, any new drug unless
4 (i) an application with respect thereto has been approved under
5 the appropriate Federal act, or (ii) when not subject to the
6 Federal act unless such drug has been tested and has not been
7 found to be unsafe or ineffective for use under the conditions
8 prescribed, recommended or suggested in the labeling thereof,
9 and prior to selling or offering for sale such drug, there has
10 been filed with the secretary an application, setting forth full
11 reports of investigations which have been made to show whether
12 or not such drug is safe and effective for use, a full list of
13 the articles used as components of such drug, a full statement
14 of the composition of such drug, a full description of the
15 methods used in and the facilities and controls used for the
16 manufacture, processing and packing of such drug, such samples
17 of such drug and of the articles used as components thereof as
18 the secretary may require, and specimens of the labeling
19 proposed to be used for such drug.
20 (b) An application provided for in subsection (a) (ii) shall
21 be submitted to the board for its recommendations but such
22 application shall become effective on the sixtieth day after the
23 filing thereof except that if the secretary finds, after due
24 notice to the applicant and giving him an opportunity for a
25 hearing, that the drug is not safe and effective for use under
26 the conditions prescribed, recommended or suggested in the
27 proposed labeling thereof, he shall prior to the effective date
28 of the application issue an order refusing to permit the
29 application to become effective.
30 (c) This section shall not apply:
19710H0851B0940 - 32 -
1 (1) To a drug intended solely for investigational use by
2 experts qualified by scientific training and experience to
3 investigate the safety in drugs, provided the drug is plainly
4 labeled "For investigational use only," or words of similar
5 import, and provided such investigator furnishes a statement to
6 the secretary showing that he has adequate facilities for such
7 investigation;
8 (2) To a drug sold in this State at any time prior to
9 enactment of this act or introduced into interstate commerce at
10 any time prior to the enactment of the Federal act; or
11 (3) To any drug which is licensed under the animal virus
12 serum and toxin law of March 4, 1913 (21 U.S.C. 151, et seq.) or
13 under the Public Health Service Act of July 1, 1944 (42 U.S.C.
14 201, et seq.).
15 (d) An order refusing to permit an application under this
16 section to become effective may be revoked by the secretary.
17 Section 11. Professional Prescription, Administration, and
18 Dispensing.--(a) A pharmacist may dispense a controlled
19 dangerous substance or drug to an individual only upon the
20 written prescription of a practitioner, except that in emergency
21 situations as prescribed by the secretary, such drug may be
22 dispensed upon oral prescription, provided that a written
23 memorandum signed by the practitioner is subsequently
24 substituted for the oral prescription. The form of the
25 prescription shall be specified by the secretary.
26 (b) No prescription for a controlled dangerous substance or
27 drug may be filled more than one month after the date on which
28 the prescription was issued. No prescription for a narcotic drug
29 may be refilled, and no prescription for any other controlled
30 dangerous substance or drug may be refilled more than five
19710H0851B0940 - 33 -
1 times.
2 (c) A physician or dentist may prescribe, administer, or
3 dispense a controlled dangerous substance or drug only (i) in
4 good faith in the course of his professional practice, (ii)
5 within the scope of the patient relationship, and (iii) in
6 accordance with treatment principles accepted by a responsible
7 segment of the medical profession. A physician or dentist may
8 cause a controlled dangerous substance or drug to be
9 administered by a professional assistant under his direction and
10 supervision.
11 (d) A veterinarian may prescribe, administer, or dispense a
12 controlled dangerous substance or drug only (i) in good faith in
13 the course of his professional practice, and (ii) not for use by
14 a human being. He may cause a controlled dangerous substance or
15 drug to be administered by a professional assistant under his
16 direction and supervision.
17 (e) Any narcotic drug dispensed by a pharmacist pursuant to
18 a written prescription shall bear a label showing (i) the
19 pharmacist's own name, address, and any registration number
20 obtained pursuant to any applicable Federal laws, (ii) the name
21 and address of the patient, or, if the patient is an animal, the
22 name and address of the owner of the animal and the species of
23 the animal, (iii) the name, address, and any registration number
24 required to be obtained pursuant to any applicable Federal laws,
25 of the practitioner by whom the prescription was written, and
26 (iv) such directions as may be stated on the prescription.
27 Section 12. Records of Distribution of Controlled Dangerous
28 Substances and Drugs.--(a) Every person who sells or otherwise
29 distributes controlled dangerous substances or drugs, shall keep
30 records of all purchases or other receipt and sales or other
19710H0851B0940 - 34 -
1 distribution of such drugs for two years from the date of
2 purchase or sale. Such records shall include the name and
3 address of the person from whom purchased or otherwise received
4 or to whom sold or otherwise distributed, the date of purchase
5 or receipt or sale or distribution, and the quantity involved.
6 (b) Every practitioner licensed by law to administer,
7 dispense or distribute narcotic drugs shall keep a record of all
8 such substances and drugs, administered, dispensed or
9 distributed by him, showing the amount administered, dispensed
10 or distributed, the date, the name and address of the patient,
11 and in the case of a veterinarian, the name and address of the
12 owners of the animal to whom such drugs are dispensed or
13 distributed. Such record shall be kept for two years from the
14 date of administering, dispensing or distributing such drug and
15 shall be open for inspection by the proper authorities.
16 Section 13. Lawful Acts.--The following acts are lawful
17 within the Commonwealth:
18 (1) The possession, control, dealing in, dispensing,
19 selling, delivery, distribution, prescription, trafficking in,
20 or giving of, any controlled drug in the regular course of a
21 business, profession, employment, occupation or duties of (i)
22 manufacturers of drugs, (ii) persons engaged in the wholesale
23 drug trade, (iii) importers or exporters of drugs, (iv)
24 registered pharmacists in any licensed pharmacy, (v) bona fide
25 owners of pharmacies or drugstores, (vi) practitioners licensed
26 by law to administer, prescribe or dispense such drugs, (vii)
27 persons in the employ of the United States or of this
28 Commonwealth or of any county, municipality or township of this
29 Commonwealth and having such drugs in their possession by reason
30 of their official duties, (viii) warehousemen or common carriers
19710H0851B0940 - 35 -
1 engaged bona fide in handling or transporting drugs, (ix) nurses
2 under the supervision of a physician, (x) persons in charge of a
3 laboratory where such drugs are used for the purpose of medical
4 or scientific investigation, teaching or analysis and not for
5 further distribution, (xi) captains or proper officers of ships,
6 upon which no regular physician is employed, for the actual
7 medical needs of the officers and crew of their own ships only,
8 (xii) persons in the bona fide employ of any of the persons
9 above enumerated, (xiii) the provisions of this clause
10 pertaining to possession shall also apply to, in addition to the
11 foregoing, (A) persons having said drugs in their possession for
12 their own personal use only: Provided, That they have obtained
13 the same in good faith, for their own use, from a practitioner
14 licensed to prescribe or dispense such drugs, or in pursuance of
15 a prescription given them by a practitioner licensed to
16 prescribe such drugs, (B) persons having said drugs in their
17 possession for the use of an animal belonging to them: Provided,
18 That they have obtained the same in good faith, from a duly
19 licensed veterinarian, for the use of such animal, or in
20 pursuance of a prescription given by a duly licensed
21 veterinarian.
22 (2) The sale, dispensation, distribution or gift by any
23 manufacturer, producer, importer or person engaged in the
24 wholesale drug trade of any controlled dangerous substance or
25 drug in pursuance of a written order signed by the person
26 authorized by law to possess, sell, dispense or prescribe such
27 drugs to whom such drug is sold, dispensed, distributed or
28 given. "Written order" hereunder shall include bills of lading,
29 invoices, receipts or written memorandums signed by the person
30 authorized by law to receive such drugs, showing the names and
19710H0851B0940 - 36 -
1 quantities of drugs purchased.
2 (3) The sale, dispensation, distribution or gift by any
3 registered pharmacist in any licensed pharmacy of any controlled
4 dangerous substance or drug to (i) a practitioner licensed by
5 law to administer, dispense or prescribe such drug, (ii) a bona
6 fide hospital, dispensary, asylum, sanatorium or public
7 institution, (iii) an individual in pursuance of a written
8 prescription, or an oral prescription subject to the
9 requirements hereinafter set forth, issued by a practitioner
10 licensed by law to prescribe such drug, which prescription shall
11 be dated as of the day on which signed and shall be signed by
12 the practitioner who issued the same, (iv) a person in charge of
13 a laboratory where such drugs are used in medical or scientific
14 investigation, teaching or analysis and not for sale or further
15 distribution, (v) the captain or proper officer of a ship upon
16 which no regular physician is employed for the actual medical
17 needs of the officers and crew of such ship only, (vi) a person
18 in the employ of the United States or of this Commonwealth or of
19 any county, municipality or township thereof, purchasing or
20 receiving the same in his official capacity.
21 (4) Using, taking, administering to the person or causing to
22 be administered to the person, or administering to any other
23 person or causing to be administered to any other person, any
24 controlled dangerous substance or drug under the advice and
25 direction and with the consent of a practitioner licensed by law
26 to prescribe or administer such drugs to human beings.
27 Section 14. Prohibited Acts; Penalties.--(a) The following
28 commercial type acts and the causing thereof within the
29 Commonwealth are hereby prohibited:
30 (1) The manufacture, sale or delivery, holding, offering for
19710H0851B0940 - 37 -
1 sale, or possession of any drug, device or cosmetic that is
2 adulterated or misbranded.
3 (2) The adulteration or misbranding of any drug, device or
4 cosmetic.
5 (3) The receipt in commerce of any drug, device or cosmetic
6 that is adulterated or misbranded and the delivery or proffered
7 delivery thereof for pay or otherwise.
8 (4) The sale, delivery for sale, holding for sale or
9 offering for sale of any article in violation of section 10.
10 (5) The dissemination or publication of any false or
11 materially misleading advertisement.
12 (6) The removal or disposal of a detained or embargoed
13 article in violation of section 25, whether or not such article
14 is in fact adulterated or misbranded.
15 (7) The adulteration, mutilation, destruction, obliteration
16 or removal of the whole or any part of the labeling of, or the
17 doing of any other act with respect to a drug, device or
18 cosmetic, if such act is done while such article is held for
19 sale and results in such article being adulterated or
20 misbranded.
21 (8) Forging, counterfeiting, simulating or falsely
22 representing, or without proper authority using any mark, stamp,
23 tag, label or other identification device authorized or required
24 by regulation promulgated under the provisions of this act.
25 (9) Placing or causing to be placed upon any drug or
26 pharmaceutical preparation, or upon the container of any drug or
27 pharmaceutical preparation, with intent to defraud, the
28 trademark, trade name or other identifying mark, imprint or
29 device of another, or any likeness of any of the foregoing.
30 (10) Selling, dispensing, disposing of or causing to be
19710H0851B0940 - 38 -
1 sold, dispensed or disposed of, or keeping in possession,
2 control or custody, or concealing any drug or pharmaceutical
3 preparation or any container of any drug or pharmaceutical
4 preparation with knowledge that the trademark, trade name or
5 other identifying mark, imprint or device of another, or any
6 likeness of any of the foregoing, has been placed thereon in a
7 manner prohibited by clause (9) hereof.
8 (11) Making, selling, disposing of or causing to be made,
9 sold, or disposed of, or keeping in possession, control or
10 custody, or concealing with intent to defraud, any punch, die,
11 plate, stone or other thing designed to print, imprint or
12 reproduce the trademark, trade name or other identifying mark,
13 imprint or device of another or any likeness of any of the
14 foregoing upon any drug, pharmaceutical preparation, or
15 container thereof.
16 (12) The use on the labeling of any drug, or in any
17 advertisement relating to such drug, of any representation or
18 suggestion that any application with respect to such drug is
19 effective under section 10 or that such drug complies with the
20 provisions of such section.
21 (13) The use of any statement or representation in
22 advertising or promoting the retail sale of any drug that the
23 seller of such drug is registered under this act.
24 (14) The sale at retail of a nonproprietary drug except by a
25 registered pharmacist in a licensed pharmacy or by a
26 practitioner.
27 (15) The operation of a drug manufacturing, wholesaling or
28 retailing establishment, except by registered pharmacists in a
29 licensed pharmacy, without conforming with such standards
30 respecting sanitation, materials, equipment and supplies as the
19710H0851B0940 - 39 -
1 secretary, after consultation with the board, may establish by
2 regulation for the protection of the public health and safety.
3 (16) Except in emergency situations and pursuant to
4 regulations of the secretary, the sale, dispensation,
5 distribution or gift by any registered pharmacist or operator of
6 a licensed pharmacy of any controlled dangerous substance or
7 drug, except in pursuance of a written order signed by the
8 person to whom such drugs are sold, dispensed, distributed or
9 given as provided for in section 11, when such drugs are sold,
10 dispensed, distributed or given to an individual in pursuance of
11 a prescription. Such prescription shall be regarded as the
12 written order herein required and no further written order shall
13 be necessary. Such orders shall be kept and preserved for a
14 period of two years. Where there is no initial written order in
15 an emergency situation, said order shall be verified by a
16 written memorandum signed by the vendee.
17 (17) The sale, dispensation, distribution, prescription or
18 gift by any practitioner otherwise authorized by law so to do of
19 any controlled drug or dangerous substance to any person known
20 to such practitioner to be a drug dependent person, unless said
21 drug is prescribed, administered, dispensed or given, for the
22 cure or treatment of some malady other than the drug habit,
23 except that a controlled drug such as methadone may be permitted
24 by such regulations for the treatment of the drug habit pursuant
25 to regulations providing for such use.
26 (18) The administration, dispensation, delivery, gift or
27 prescription by any practitioner otherwise authorized by law so
28 to do of any controlled dangerous substance or drug except after
29 a physical examination of the person or animal for whom said
30 drugs are intended, said examination to be made at the time said
19710H0851B0940 - 40 -
1 prescription is issued or at the time said drug is administered,
2 dispensed, given away or delivered by said practitioner, or
3 except where the practitioner is satisfied by evidence that the
4 person is not a drug dependent person. No veterinarian shall
5 sell, dispense, distribute, give or prescribe any narcotic drug
6 for the use of a human being.
7 (19) The sale at retail or dispensing of any controlled drug
8 or dangerous substance to any person, except to one authorized
9 by law to sell, dispense, prescribe or possess such drugs or
10 substances, unless upon the written or oral prescription of a
11 person licensed by law to prescribe such drug and unless
12 compounded or dispensed by a registered pharmacist or under the
13 immediate personal supervision of a registered pharmacist, or
14 the refilling of a written or oral prescription for a drug,
15 unless such refilling is authorized by the prescriber either in
16 the original written prescription or by written confirmation of
17 the original oral prescription. The provisions of this
18 subsection shall not apply to a practitioner licensed to
19 prescribe or dispense such drugs, who keeps a record of the
20 amount of such drugs purchased and a dispensing record showing
21 the date, name, and quantity of the drug dispensed and the name
22 and address of the patient, as required by this act.
23 (20) The dispensing of any controlled drug or dangerous
24 substance by a pharmacist without affixing to the container in
25 which the drug is sold or dispensed a label bearing the name and
26 address of such pharmacist, the name and address of the patient,
27 the date compounded and the consecutive number of the
28 prescription under which it is recorded in his prescription
29 files, together with the name of the practitioner prescribing
30 it.
19710H0851B0940 - 41 -
1 (21) The dispensing of a controlled drug or dangerous
2 substance by a practitioner otherwise authorized by law so to do
3 without affixing to the container in which the drug is sold or
4 dispensed a label bearing the name and address of the
5 practitioner, the date dispensed, the name and address of the
6 patient and the directions for the use of the drug by the
7 patient.
8 (22) The selling or possession by a pharmacy or wholesaler
9 of any drug or controlled dangerous substance defined herein
10 unless the container bears a label, securely attached thereto,
11 stating conspicuously the specific name of the drug and the
12 proportion or amount thereof. Such label shall not be necessary
13 when the drug is dispensed by a pharmacist upon a prescription
14 or dispensed by a practitioner authorized by law to dispense
15 such drugs to his own patients and the container is labeled in
16 the manner prescribed in this act.
17 (23) The purchase or receipt in commerce by any person of
18 any drugs or devices from any person not authorized by law to
19 sell, distribute, dispense or otherwise deal in such drugs or
20 devices.
21 (24) The using by any person to his own advantage or
22 revealing other than to the secretary or officers or employes of
23 the Department of Health or to the council or to the board or to
24 courts or a hearing examiner when relevant to proceedings under
25 this act any information acquired under authority of this act
26 concerning any method or process which as a trade secret is
27 entitled to protection. Such information obtained under the
28 authority of this act shall not be admitted in evidence in any
29 proceeding before any court of the Commonwealth except in
30 proceedings under this act.
19710H0851B0940 - 42 -
1 Any person who violates any of the provisions of this
2 subsection (a) shall be guilty of a misdemeanor, and shall, on
3 conviction thereof, be sentenced to imprisonment for not more
4 than one year or a fine of not more than five thousand dollars
5 ($5,000), or both; but if the violation is committed after a
6 prior conviction of such person, for a violation of this act
7 under this section, has become final, such person shall be
8 sentenced to imprisonment for not more than three years or a
9 fine of not more than twenty-five thousand dollars ($25,000), or
10 both.
11 (b) Any person who is an otherwise legitimate producer,
12 manufacturer, or distributor and who fails to register or obtain
13 a license as required by this act shall be guilty of a
14 misdemeanor, and shall, on conviction thereof, be punished only
15 as follows:
16 (1) Upon conviction of the first such offense, he shall be
17 sentenced to imprisonment for not more than six months, or fined
18 not exceeding ten thousand dollars ($10,000), or both.
19 (2) Upon conviction of the second and subsequent such
20 offense, he shall be sentenced to imprisonment for not more than
21 two years, or fined not exceeding forty thousand dollars
22 ($40,000), or both.
23 (c) Any person who fails to maintain or permit inspection of
24 records as required by this act or divulges information in
25 violation of this act shall be guilty of a felony, and shall, on
26 conviction thereof, be punished as follows:
27 (1) Upon conviction of the first such offense, he shall be
28 sentenced to imprisonment for not more than two years, or fined
29 not exceeding ten thousand dollars ($10,000), or have his
30 license revoked for not exceeding one year, or any of these.
19710H0851B0940 - 43 -
1 (2) Upon conviction of the second and subsequent such
2 offense, he shall be sentenced to imprisonment for not more than
3 ten years, or fined not exceeding thirty thousand dollars
4 ($30,000), or have his license revoked for not more than five
5 years, or any of these.
6 (d) Any person, not authorized by law to do so, who
7 acquires, receives, possesses, stores, sells or distributes any
8 controlled paraphernalia shall be guilty of a felony and shall,
9 on conviction thereof, be sentenced to imprisonment for not more
10 than three years or a fine of not more than five thousand
11 dollars ($5,000), or both.
12 (e) It shall be unlawful for any person to obtain or attempt
13 to obtain a controlled dangerous substance or drug by:
14 (1) Misrepresentation, deception, or subterfuge, (i) from
15 any person that he believes uses such a substance or drug in
16 research, teaching, or chemical analysis, and who in fact is
17 authorized by law to administer, dispense, or distribute such a
18 substance or drug; or (ii) from any person that he believes is
19 lawfully entitled to possess and distribute a controlled
20 dangerous substance or drug, and who in fact is authorized by
21 law to administer, dispense, or distribute such a substance or
22 drug;
23 (2) Use of a prescription that has been forged, or that has
24 been altered by someone other than the prescribing practitioner;
25 or
26 (3) Use of a false name or address on a prescription.
27 Any person who obtained a controlled drug or dangerous
28 substance by any means of fraud or deceit as herein set forth
29 shall be guilty of a misdemeanor and shall, upon conviction
30 thereof, be punished as follows:
19710H0851B0940 - 44 -
1 (1) Upon conviction of the first such offense, he shall be
2 sentenced to imprisonment for not more than one year, or fined
3 not exceeding five thousand dollars ($5,000), or both.
4 (2) Upon conviction of the second and subsequent such
5 offense, he shall be sentenced to imprisonment for not more than
6 two years, or fined not exceeding ten thousand dollars
7 ($10,000), or both.
8 (3) Any person who is a drug dependent person and who
9 violates this provision to satisfy his drug dependence, and who
10 is not charged with a trafficking offense involving distribution
11 of a controlled drug or dangerous substance at wholesale or
12 distribution at retail of any controlled drug or dangerous
13 substance as part of an organized professional system, shall be
14 handled only pursuant to the provisions relating to care,
15 treatment and civil commitment.
16 (f) It shall be unlawful for any person who is not
17 registered or licensed as required by law to possess a
18 controlled drug or dangerous substance with intent to distribute
19 it or to distribute a controlled drug or dangerous substance in
20 violation of this act and shall, upon conviction thereof, be
21 punished as follows:
22 (1) Trafficking in the First Degree. A person who in
23 violation of this act possesses a controlled drug or dangerous
24 substance except marihuana with intent to distribute it or who
25 in violation of this act distributes a controlled drug or
26 dangerous substance except marihuana at wholesale to another
27 distributor shall be guilty of a felony, and shall, on
28 conviction thereof, be punished as follows:
29 (i) upon conviction of the first such offense involving a
30 controlled drug or dangerous substance classified in Schedule I
19710H0851B0940 - 45 -
1 or II which is a narcotic drug, such person shall be sentenced
2 to imprisonment for not more than twenty years and fined without
3 limitation an amount sufficient to exhaust the assets utilized
4 in and the profits obtained by the illegal activity and upon
5 conviction of the second and subsequent such offense, he shall
6 be sentenced to imprisonment for not more than life, and fined
7 without limitation an amount sufficient to exhaust the assets
8 utilized in and the profits obtained by the illegal activity;
9 (ii) upon conviction of the first such offense involving a
10 controlled drug or dangerous substance classified in Schedule I
11 or II which is not a narcotic drug or any controlled drug or
12 dangerous substance classified in Schedule III, such person
13 shall be sentenced to imprisonment for not more than five years,
14 or fined not exceeding fifteen thousand dollars ($15,000), or
15 both and upon conviction of the second and subsequent such
16 offense, he shall be sentenced to imprisonment for not more than
17 ten years, or fined not exceeding thirty thousand dollars
18 ($30,000), or both;
19 (iii) upon conviction of the first such offense involving a
20 controlled drug or dangerous substance classified in Schedule
21 IV, such person shall be sentenced to imprisonment for not more
22 than three years, or fined not exceeding ten thousand dollars
23 ($10,000), or both and upon conviction of the second and
24 subsequent such offense, he shall be sentenced to imprisonment
25 of not more than six years, or fined not exceeding twenty
26 thousand dollars ($20,000), or both;
27 (iv) upon conviction of the first such offense involving a
28 controlled drug or dangerous substance classified in Schedule V,
29 such person shall be sentenced to imprisonment of not more than
30 one year, or fined not exceeding five thousand dollars ($5,000),
19710H0851B0940 - 46 -
1 or both and upon conviction of the second and subsequent such
2 offense, he shall be sentenced to imprisonment for not more than
3 two years, or fined not exceeding ten thousand dollars
4 ($10,000), or both.
5 (2) Trafficking in the Second Degree. A person who in
6 violation of this act possesses a controlled drug or dangerous
7 substance except marihuana with intent to distribute it to an
8 ultimate user thereof in violation of this act, or who in
9 violation of this act distributes a controlled drug or dangerous
10 substance except marihuana to an ultimate user thereof, shall be
11 guilty of a felony, and shall, on conviction thereof, be
12 punished as follows:
13 (i) upon conviction of the first such offense involving a
14 controlled drug or dangerous substance classified in Schedule I
15 or II which is a narcotic drug, such person shall be sentenced
16 to imprisonment for not more than twenty years, and fined an
17 amount sufficient to exhaust the assets utilized in and the
18 profits obtained by the illegal activity, and upon conviction of
19 the second and subsequent such offense, he shall be sentenced to
20 imprisonment for not more than forty years, and fined an amount
21 sufficient to exhaust the assets utilized in and the profits
22 obtained by the illegal activity;
23 (ii) upon conviction of the first such offense involving a
24 controlled drug or dangerous substance classified in Schedule I
25 or II which is not a narcotic drug or any controlled drug or
26 dangerous substance classified in Schedule III, such person
27 shall be sentenced to imprisonment for not more than five years,
28 or fined not exceeding five thousand dollars ($5,000), or both
29 and upon conviction of the second and subsequent such offense,
30 he shall be sentenced to imprisonment for not more than ten
19710H0851B0940 - 47 -
1 years, or fined not exceeding ten thousand dollars ($10,000), or
2 both;
3 (iii) upon conviction of the first such offense involving a
4 controlled drug or dangerous substance classified in Schedule
5 IV, such person shall be sentenced to imprisonment for not more
6 than three years, or fined not exceeding three thousand dollars
7 ($3,000), or both and upon conviction of the second and
8 subsequent such offense, he shall be sentenced to imprisonment
9 for not more than six years, or fined not exceeding six thousand
10 dollars ($6,000), or both;
11 (iv) upon conviction of the first such offense involving a
12 controlled drug or dangerous substance classified in Schedule V,
13 such person shall be sentenced to imprisonment for not more than
14 one year, or fined not exceeding two thousand dollars ($2,000),
15 or both, and upon conviction of the second and subsequent such
16 offense, he shall be sentenced to imprisonment for not more than
17 two years, or fined not exceeding three thousand dollars
18 ($3,000), or both.
19 (3) Trafficking in the Third Degree. A person who in
20 violation of this act possesses marihuana with intent to
21 distribute it, or who in violation of this act distributes
22 marihuana, shall be guilty of a felony, and shall, on conviction
23 thereof, be punished as follows:
24 (i) upon conviction of the first such offense, he shall be
25 sentenced to imprisonment for not more than ten years, and fined
26 an amount sufficient to exhaust the assets utilized in and the
27 profits obtained by the illegal activity;
28 (ii) upon conviction of the second such offense, he shall be
29 sentenced to imprisonment for not more than twenty years, and
30 fined an amount sufficient to exhaust the assets utilized in and
19710H0851B0940 - 48 -
1 the profits obtained by the illegal activity.
2 (g) Any person who manufactures or distributes a counterfeit
3 drug or substance or who possesses a counterfeit drug or
4 substance with intent to distribute it, knowing it to be a
5 counterfeit drug or substance, or who manufactures or
6 distributes any device intended to reproduce any identifying
7 name or mark upon any drug or substance or container or labeling
8 so as to render such drug or substance a counterfeit drug, shall
9 be guilty of a felony, and shall, upon conviction thereof, be
10 punished as follows:
11 (1) Upon conviction of the first such offense involving a
12 counterfeit substance classified in Schedule I or II which is a
13 narcotic drug, such person shall be sentenced to imprisonment
14 for not more than ten years, and fined without limitation in an
15 amount sufficient to exhaust the assets utilized in and the
16 profits obtained by the illegal activity and upon conviction of
17 the second and subsequent such offense, he shall be sentenced to
18 imprisonment for not more than thirty years, and fined without
19 limitation an amount sufficient to exhaust the assets utilized
20 in and the profits obtained by the illegal activity.
21 (2) Upon conviction of the first such offense involving a
22 counterfeit substance classified in Schedule I or II which is
23 not a narcotic drug or any counterfeit substance classified in
24 Schedule III, shall be sentenced to imprisonment for not more
25 than five years, or fined not exceeding ten thousand dollars
26 ($10,000), or both and upon the second and subsequent such
27 offense, he shall be sentenced to imprisonment for not more than
28 ten years, or fined not exceeding twenty thousand dollars
29 ($20,000), or both.
30 (3) Upon conviction of the first such offense involving a
19710H0851B0940 - 49 -
1 counterfeit substance classified in Schedule IV, such person
2 shall be sentenced to imprisonment for not more than three
3 years, or fined not exceeding seven thousand five hundred
4 dollars ($7,500), or both and upon conviction of the second and
5 subsequent such offense, he shall be sentenced to imprisonment
6 for not more than six years, or fined not exceeding fifteen
7 thousand dollars ($15,000), or both.
8 (4) Upon conviction of the first such offense involving a
9 counterfeit substance classified in Schedule V, such person
10 shall be sentenced to imprisonment for not more than one year,
11 or fined not exceeding five thousand dollars ($5,000), or both
12 and upon conviction of the second and subsequent such offense,
13 he shall be sentenced to imprisonment for not more than two
14 years, or fined not exceeding ten thousand dollars ($10,000), or
15 both.
16 (h) Any person who acquires a controlled drug or dangerous
17 substance in violation of this act with intent to distribute,
18 administer, or dispense it in accordance with this act, or who
19 acquires a controlled drug or dangerous substance in violation
20 of this act and distributes, administers, or dispenses it in
21 accordance with this act, shall be guilty of a felony, and
22 shall, on conviction thereof, be punished only as follows:
23 (1) Upon conviction of the first such offense involving a
24 controlled drug or dangerous substance classified in Schedule I
25 or II which is a narcotic drug, such person shall be sentenced
26 to imprisonment for not more than four years, or fined not
27 exceeding twenty thousand dollars ($20,000), or have his license
28 suspended for not exceeding six months, or any of these and upon
29 conviction of the second and subsequent such offense, he shall
30 be sentenced to imprisonment for not more than ten years, or
19710H0851B0940 - 50 -
1 fined not exceeding fifty thousand dollars ($50,000), or have
2 his license suspended or revoked, or any of these.
3 (2) Upon conviction of the first such offense involving a
4 controlled drug or dangerous substance classified in Schedule I
5 or II which is not a narcotic drug and any controlled drug or
6 dangerous substance classified in Schedule III, such person
7 shall be sentenced to imprisonment for not more than three
8 years, or fined not exceeding fifteen thousand dollars
9 ($15,000), or have his license suspended for not exceeding four
10 months, or any of these and upon conviction of the second and
11 subsequent such offense, he shall be sentenced to imprisonment
12 for not more than eight years, or fined not exceeding thirty
13 thousand dollars ($30,000), or have his license suspended or
14 revoked, or any of these.
15 (3) Upon conviction of the first such offense involving a
16 controlled drug or dangerous substance classified in Schedule
17 IV, such person shall be sentenced to imprisonment for not more
18 than two years, or fined not exceeding ten thousand dollars
19 ($10,000), or have his license suspended for not exceeding three
20 months, or any of these and upon conviction of the second and
21 subsequent such offense, he shall be sentenced to imprisonment
22 for not more than six years, or fined not exceeding twenty
23 thousand dollars ($20,000), or have his license suspended or
24 revoked, or any of these.
25 (4) Upon conviction of the first such offense involving a
26 controlled drug or dangerous substance classified in Schedule V,
27 such person shall be sentenced to imprisonment for not more than
28 one year, or fined not exceeding five thousand dollars ($5,000),
29 or have his license suspended for not exceeding two months, or
30 any of these and upon conviction of the second and subsequent
19710H0851B0940 - 51 -
1 offense, he shall be sentenced to imprisonment for not more than
2 four years, or fined not exceeding ten thousand dollars
3 ($10,000), or have his license suspended or revoked, or any of
4 these.
5 (i) Any person who prescribes, administers, dispenses, or
6 investigates a controlled drug or dangerous substance in
7 violation of this act shall be guilty of a misdemeanor for the
8 first and second offense and shall be guilty of a felony for the
9 third and subsequent offense and shall, on conviction thereof,
10 be punished as follows:
11 (1) Upon conviction of the first and second such offense
12 involving a controlled drug or dangerous substance classified in
13 Schedule I or II which is a narcotic drug, such person shall be
14 sentenced to imprisonment for not more than one year, or fined
15 not more than five thousand dollars ($5,000), or have his
16 license suspended for not exceeding three months, or any of
17 these and upon conviction of the third and subsequent such
18 offense he shall be sentenced to imprisonment for not more than
19 ten years, or fined not exceeding thirty thousand dollars
20 ($30,000), or have his license suspended or revoked, or any of
21 these.
22 (2) Upon conviction of the first and second such offense
23 involving a controlled drug or dangerous substance classified in
24 Schedule I or II which is not a narcotic drug, and any
25 controlled or dangerous substance classified in Schedule III,
26 such person shall be sentenced to imprisonment for not more than
27 six months, or fined not more than three thousand dollars
28 ($3,000), or have his license suspended for not exceeding two
29 months, or any of these and upon conviction of the third and
30 subsequent such offense he shall be sentenced to imprisonment
19710H0851B0940 - 52 -
1 for not more than eight years, or fined not exceeding eighteen
2 thousand dollars ($18,000), or have his license suspended or
3 revoked, or any of these.
4 (3) Upon conviction of the first and second such offense
5 involving a controlled drug or dangerous substance classified in
6 Schedule IV, such person shall be sentenced to imprisonment for
7 not more than three months, or fined not exceeding two thousand
8 dollars ($2,000), or have his license suspended for not
9 exceeding one month, or any of these and upon conviction of the
10 third and subsequent such offense he shall be sentenced to
11 imprisonment for not more than six years, or fined not exceeding
12 twelve thousand dollars ($12,000), or have his license suspended
13 or revoked, or any of these.
14 (4) Upon conviction of the first and second such offense
15 involving a controlled drug or dangerous substance classified in
16 Schedule V, such person shall be sentenced to imprisonment for
17 not more than two months, or fined not exceeding one thousand
18 dollars ($1,000), or have his license suspended for not
19 exceeding one month, or any of these and upon conviction of the
20 third and subsequent such offense he shall be sentenced to
21 imprisonment for not more than four years, or fined not
22 exceeding six thousand dollars ($6,000), or have his license
23 suspended or revoked, or any of these.
24 (j) Any person who has possession illegally of any
25 controlled drug or dangerous substance for personal use or
26 distribution not for remuneration shall be guilty of a
27 misdemeanor, and shall, on conviction thereof, be punished only
28 as follows:
29 (1) Possession in the First Degree. Any person who in
30 violation of this act possesses a controlled drug or dangerous
19710H0851B0940 - 53 -
1 substance except marihuana for personal use, or who in violation
2 of this act possesses a controlled drug or dangerous substance
3 except marihuana with intent to distribute it but not for
4 remuneration or for the purpose of making another dependent upon
5 the drug or substance, or who in violation of this act
6 distributes a controlled drug or dangerous substance except
7 marihuana but not for remuneration or for the purpose of making
8 another dependent upon the drug or substance, shall be
9 admonished by the court about the seriousness of the violation,
10 or required to complete a course on drug abuse prescribed by the
11 council, or imprisoned not exceeding two years, or fined not
12 exceeding ten thousand dollars ($10,000), or any of these.
13 (2) Possession in the Second Degree. Any person who in
14 violation of this act possesses marihuana for personal use, or
15 who in violation of this act possesses marihuana with intent to
16 distribute it but not for remuneration or for the purpose of
17 introducing another to the drug, or who in violation of this act
18 distributes marihuana but not for remuneration or for the
19 purpose of introducing another to the drug shall be admonished
20 by the court about the seriousness of the violation, or required
21 to complete a prescribed course on drug abuse, or imprisonment
22 not exceeding thirty days, or fined not exceeding five hundred
23 dollars ($500), or any of these.
24 Section 15. Additional Penalties.--Any penalty imposed for
25 violation of this act shall be in addition to, and not in lieu
26 of, any civil or administrative penalty or sanction authorized
27 by law.
28 Section 16. Distribution to Persons Under Age Eighteen.--Any
29 person who is at least eighteen years of age who violates this
30 act by distributing a controlled substance listed in Schedules I
19710H0851B0940 - 54 -
1 or II which is a narcotic drug to a person under eighteen years
2 of age who is at least three years his junior is punishable by a
3 term of imprisonment up to twice that otherwise authorized by
4 subsection (f) of section 14 of this act, in addition to any
5 fine authorized by this act. Any person who is at least eighteen
6 years of age who violates this act by distributing any other
7 controlled drug or dangerous substance listed in Schedules I,
8 II, III, IV and V to a person under eighteen years of age who is
9 at least three years his junior is punishable by a term of
10 imprisonment up to twice that authorized by subsection (f) of
11 section 14 of this act, in addition to any fine authorized by
12 this act. Imposition or execution of such sentence shall not be
13 suspended and probation shall not be granted.
14 Section 17. Enforcement Provisions.--The following
15 guidelines shall be applicable in the enforcement of any
16 penalties imposed by this act:
17 (1) No publisher, radio broadcast licensee, or agency or
18 medium for the dissemination of an advertisement, except the
19 manufacturer, distributor or seller of the article to which a
20 false advertisement relates, shall be liable under section 14 of
21 this act by reason of the dissemination by him of such false
22 advertisement unless he has refused on the request of the
23 secretary to furnish the secretary with the name and post office
24 address of the manufacturer, distributor, seller or advertising
25 agency who causes him to disseminate such advertisement or
26 unless he publishes such advertisement knowing or having good
27 cause to know that it is false or otherwise in violation of the
28 law.
29 (2) For purposes of this section, any adjudication of
30 violation or conviction under any Federal or State law or of any
19710H0851B0940 - 55 -
1 ordinance of any political subdivision relating to any
2 controlled drug or substance other than a juvenile violation,
3 shall constitute a prior offense if it related to the type of
4 conduct against which a subsequent offense is directed.
5 (3) Any penalty relating to license suspension or revocation
6 shall be executed by the appropriate licensing agency upon
7 receipt of a court order setting forth the penalty.
8 (4) No person shall be convicted of an offense under section
9 14 of this act unless he knew with respect to each element of
10 the offense that he was engaged in the act or omission
11 prescribed, but knowledge that the act or omission constituted a
12 civil or criminal offense shall not be required for conviction.
13 (5) Imprisonment may be imposed for failure to pay all or
14 any part of a fine imposed under this section only when the
15 offender does not show that such failure is caused by indigence
16 or a lack of sufficient funds.
17 (6) All fines collected under this section shall be utilized
18 for the treatment and rehabilitation services established by
19 law.
20 (7) The probation or parole or other conditional release of
21 any drug abuser or drug dependent person convicted of an offense
22 under this act or of any other offense may be conditioned on the
23 person's agreement to periodic urine analyses. Neither a relapse
24 into drug abuse one or more times or the failure to conform to a
25 set schedule for rehabilitation, or both, shall be sufficient in
26 themselves to require that his status be revoked or treatment
27 denied.
28 (8) The court without a jury shall hold a full and fair
29 hearing for the purpose of setting the amount of any fine
30 pursuant to this section, during which the district attorney and
19710H0851B0940 - 56 -
1 the defendant may introduce evidence. The defendant shall be
2 permitted to cross-examine any adverse witness or rebut any
3 adverse evidence. The amount of any fine set by the court shall
4 be supported by substantial evidence.
5 (9) A person may be entitled to probation without verdict
6 under the following circumstances:
7 (i) A person who has not previously been convicted of an
8 offense relating to a controlled drug or dangerous substance
9 under any law of this Commonwealth, the United States, or any
10 other state, shall be eligible for probation without verdict if
11 he pleads nolo contendere or guilty to, or is found guilty of,
12 any offense under this act. The court may, without entering a
13 judgment, and with the consent of such person, defer further
14 proceedings and place him on probation for a specific time
15 period upon such reasonable terms and conditions as it may
16 require. Probation without verdict shall not be available to any
17 such person who is charged with a trafficking offense involving
18 distribution of a controlled drug or dangerous substance at
19 wholesale or distribution at retail of any controlled drug or
20 dangerous substance as part of an organized professional system.
21 (ii) Upon violation of a term or condition of probation, the
22 court may enter a judgment and proceed as in any criminal case,
23 or may continue the probation without verdict.
24 (iii) Upon fulfillment of the terms and conditions of
25 probation, the court shall discharge such person and dismiss the
26 proceedings against him. Discharge and dismissal shall be
27 without adjudication of guilt and shall not constitute a
28 conviction for any purpose whatever: Provided, That probation
29 without verdict shall be available to any person only once.
30 Section 18. Offenses by a Corporation, Copartnership or
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1 Association.--If any violation of the provisions of this act is
2 by a corporation, copartnership or association, the officers and
3 directors of such corporation or the members of such
4 copartnership or association, the agents and employes with prior
5 guilty knowledge of the fact, shall be deemed guilty of a
6 violation of the provisions of this act to the same extent as
7 though said violation were committed by them personally.
8 Section 19. Expunging Criminal Records.--(a) Any arrest for
9 a criminal offense under this act or under the provisions
10 previously governing narcotics and dangerous drugs or substances
11 in the Commonwealth of Pennsylvania, or any political
12 subdivision thereof, shall promptly be expunged from the
13 person's public arrest and other public criminal records when
14 the charges are withdrawn or dismissed or the person is
15 acquitted of the charges.
16 (b) Any conviction of a criminal offense under this act or
17 under the provisions previously governing narcotics and
18 dangerous drugs or substances in the Commonwealth of
19 Pennsylvania or any political subdivision thereof may be
20 expunged from all public criminal records by a court upon the
21 filing of a petition supported by substantial evidence of good
22 conduct since the petitioner's conviction. Copies of the
23 petition shall be served on the Attorney General and the
24 district attorney, who shall be responsible for consulting other
25 appropriate public agencies and departments. If a district
26 attorney files a motion to dismiss the petition within sixty
27 days, the court, without a jury, shall hold a full and fair
28 hearing before ruling on the issue. The petitioner shall have
29 the right to cross-examine any adverse witness or rebut any
30 adverse evidence. The proceeding shall be private. The petition
19710H0851B0940 - 58 -
1 shall be granted if supported by substantial evidence of good
2 conduct since the petitioner's conviction unless the court
3 finds, on the basis of evidence of record, good cause not to
4 accept the petitioner's allegations of good conduct. The
5 petition may be filed and heard only after the following time
6 lapses:
7 (1) For a conviction for trafficking in the third degree or
8 possession in the second degree, or any offense under prior law
9 that would not come within any of these provisions, after two
10 years from the date or release from a penal institution or from
11 the date of conviction if not sent to a penal institution.
12 (2) For a conviction for possession in the first degree, or
13 any offense under prior law that would not come within any of
14 these provisions, after three years from the date of release
15 from a penal institution or from the date of conviction if not
16 sent to a penal institution.
17 (3) For a conviction for any other offense under this act,
18 or any offense under prior law that would now come within any of
19 these provisions, or any offense under prior law governing
20 narcotics and controlled drugs or dangerous substances that
21 would not now come within any of these provisions, after three
22 years from the date of release from a penal institution or from
23 the date of conviction if not sent to a penal institution.
24 (c) Any expunged arrest or conviction shall not thereafter
25 be regarded as an arrest or conviction for the purpose of any
26 statute or regulation or license or questionnaire or any other
27 public or private purpose: Provided, That it shall continue to
28 constitute an offense for purposes of any criminal statute under
29 which the existence of a prior conviction is relevant to the
30 penalty to be imposed. No person shall be permitted to learn of
19710H0851B0940 - 59 -
1 an expunged arrest or conviction, or of the expungement, by any
2 means whatever: Provided, That the judiciary, court personnel,
3 and district attorneys may learn of an expunged arrest or
4 conviction, and of the expungement, where it becomes relevant to
5 a penalty to be imposed in a subsequent case. Any person who
6 seeks or divulges such information in violation of this
7 subsection shall be guilty of a misdemeanor, and shall, upon
8 conviction thereof be punished by imprisonment not exceeding
9 ninety days, or a fine not exceeding one thousand dollars
10 ($1,000), or both.
11 Section 20. Burden of Proving Exemptions.--In any
12 prosecution under this act, it shall not be necessary to negate
13 any of the exemptions of this act in any complaint, information
14 or indictment. The burden of proving any exemption under this
15 act shall be upon the defendant.
16 Section 21. Revocation of Licenses of Practitioners.--(a)
17 Any license heretofore issued to any physician, dentist,
18 veterinarian, pharmacist or registered nurse may be either
19 revoked or suspended by the proper officers or boards having
20 power to issue licenses to any of the foregoing, upon proof that
21 the licensee is addicted to the use of any narcotic drugs, after
22 giving such licensee reasonable notice and opportunity to be
23 heard.
24 (b) The appropriate licensing boards in the Department of
25 Education are hereby authorized to revoke or suspend the
26 registration or license of any physician, surgeon, dentist,
27 veterinarian, pharmacist or nurse, when such person has pleaded
28 guilty or nolo contendere or has been found guilty by a judge or
29 jury of violating any State or Federal law pertaining to the
30 sale, use or distribution of narcotics. Before any such
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1 revocation or suspension, the licensee or registrant shall be
2 given a hearing before the appropriate board. At such hearing
3 the accused may be represented by counsel and shall be entitled
4 to compulsory attendance of witnesses.
5 Section 22. Administrative Inspections and Warrants.--(a) As
6 used in this section, the term "controlled premises" means:
7 (1) Places where original or other records or documents
8 required under this act are kept or required to be kept; and
9 (2) Places, including factories, warehouses, or other
10 establishments, and conveyances, where persons registered under
11 section 6 (or exempted from registration under section 6) may
12 lawfully hold, manufacture, or distribute, dispense, administer
13 or otherwise dispose of controlled substances.
14 (b) (1) For the purpose of inspecting, copying, and
15 verifying the correctness of records, reports, or other
16 documents required to be kept or made under this act and
17 otherwise facilitating the carrying out of his functions under
18 this act, the Secretary of Health is authorized, in accordance
19 with this section, to enter controlled premises and to conduct
20 administrative inspections thereof, and of the things specified
21 in this section, relevant to those functions.
22 (2) Such entries and inspections shall be carried out
23 through officers or employes (hereinafter referred to as
24 "agents") designated by the secretary. Any such agent upon
25 stating his purpose and presenting to the owner, operator, or
26 agent in charge of such premises (i) appropriate credentials and
27 (ii) a written notice of his inspection authority (which notice
28 in the case of an inspection requiring, or in fact supported by,
29 an administrative inspection warrant shall consist of such
30 warrant), shall have the right to enter such premises and
19710H0851B0940 - 61 -
1 conduct such inspection at reasonable times.
2 (3) Except as may otherwise be indicated in an applicable
3 inspection warrant, the agent shall have the right: (i) to
4 inspect and copy records, reports, and other documents required
5 to be kept or made under this act; (ii) to inspect, within
6 reasonable limits and in a reasonable manner, controlled
7 premises and all pertinent equipment, finished and unfinished
8 drugs and other substances or materials, containers, and
9 labeling found therein, and, except as provided in clause (5) of
10 this subsection, all other things therein (including records,
11 files, papers, processes, controls, and facilities) appropriate
12 for verification of the records, reports, and documents referred
13 to in subclause (i) or otherwise bearing on the provisions of
14 this act; and (iii) to inventory any stock of any controlled
15 substance therein and obtain samples of any such substance.
16 (4) Except when the owner, operator, or agent in charge of
17 the controlled premises so consents in writing, no inspection
18 authorized by this section shall extend to: (i) financial data;
19 (ii) sales data other than shipment data; or (iii) pricing data.
20 (c) A warrant under this section shall not be required for
21 the inspection of books and records pursuant to an
22 administrative subpoena issued in accordance with any provisions
23 of any Act of Assembly nor for entries and administrative
24 inspections (including seizures of property):
25 (1) With the consent of the owner, operator, or agent in
26 charge of the controlled premises;
27 (2) In situations presenting imminent danger to health or
28 safety;
29 (3) In situations involving inspection of conveyances where
30 there is reasonable cause to believe that the mobility of the
19710H0851B0940 - 62 -
1 conveyance makes it impracticable to obtain a warrant;
2 (4) In any other exceptional or emergency circumstance where
3 time or opportunity to apply for a warrant is lacking; or
4 (5) In any other situations where a warrant is not
5 constitutionally required.
6 (d) Issuance and execution of administrative inspection
7 warrants shall be as follows:
8 (1) Any judge of a Commonwealth court of record, may, within
9 his territorial jurisdiction, and upon proper oath or
10 affirmation showing probable cause, issue warrants for the
11 purpose of conducting administrative inspections authorized by
12 this act or regulations thereunder, and seizures of property
13 appropriate to such inspections. For the purposes of this
14 section, the term "probable cause" means a valid public interest
15 in the effective enforcement of this act or regulations
16 thereunder sufficient to justify administrative inspections of
17 the area, premises, building, or conveyance, or contents
18 thereof, in the circumstances specified in the application for
19 the warrant.
20 (2) A warrant shall issue only upon an affidavit of an
21 officer or employe having knowledge of the facts alleged, sworn
22 to before the judge and establishing the grounds for issuing the
23 warrant. If the judge is satisfied that grounds for the
24 application exist or that there is probable cause to believe
25 they exist, he shall issue a warrant identifying the area,
26 premises, building, or conveyance to be inspected, the purpose
27 of such inspection, and, where appropriate, the type of property
28 to be inspected, if any. The warrant shall identify the items or
29 types of property to be seized, if any. The warrant shall be
30 directed to a person authorized under subsection (b) (2) to
19710H0851B0940 - 63 -
1 execute it. The warrant shall state the grounds for its issuance
2 and the name of the person or persons whose affidavit has been
3 taken in support thereof. It shall command the person to whom it
4 is directed to inspect the area, premises, building, or
5 conveyance identified for the purpose specified, and, where
6 appropriate, shall direct the seizure of the property specified.
7 The warrant shall direct that it be served during normal
8 business hours. It shall designate the judge to whom it shall be
9 returned.
10 (3) A warrant issued pursuant to this section must be
11 executed and returned within ten days of its date unless, upon a
12 showing by the Secretary of Health of a need therefor, the judge
13 allows additional time in the warrant. If property is seized
14 pursuant to a warrant, the person executing the warrant shall
15 give to the person from whom or from whose premises the property
16 was taken a copy of the warrant and a receipt for the property
17 taken or shall leave the copy and receipt at the place from
18 which the property was taken. The return of the warrant shall be
19 made promptly and shall be accompanied by a written inventory of
20 any property taken. The inventory shall be made in the presence
21 of the person executing the warrant and of the person from whose
22 possession or premises the property was taken, if they are
23 present, or in the presence of at least one credible person
24 other than the person making such inventory, and shall be
25 verified by the person executing the warrant. The judge upon
26 request, shall deliver a copy of the inventory to the person
27 from whom or from whose premises the property was taken and to
28 the applicant for the warrant.
29 (4) The judge who has issued a warrant under this section
30 shall attach to the warrant a copy of the return and all papers
19710H0851B0940 - 64 -
1 filed in connection therewith and shall file them with the clerk
2 of the court for the judicial district in which the inspection
3 was made.
4 Section 23. Injunctive Relief.--In addition to the remedies
5 provided herein, the secretary is hereby authorized to apply to
6 the court of common pleas in the county in which such violation
7 occurs or to the Commonwealth Court for, and such court shall
8 have jurisdiction to grant, a temporary or permanent injunction
9 restraining any person from continued violation of any provision
10 of this act irrespective of the existence of an adequate remedy
11 at law.
12 Section 24. Cooperation With Other Authorities.--The
13 agencies charged with the enforcement of this act shall actively
14 cooperate and coordinate with the agencies charged with the
15 enforcement of all Federal and State laws relating to the
16 regulation of the distribution of controlled drugs or dangerous
17 substances.
18 Section 25. Embargo and Seizure.--(a) Whenever a duly
19 authorized agent of the secretary finds or has probable cause to
20 believe that any drug, device or cosmetic is adulterated or
21 misbranded or contraband, the same shall be deemed subject to
22 embargo and he shall affix to such article or articles a tag or
23 other appropriate marking, approved by the secretary, giving
24 notice that such article is or is suspected of being
25 adulterated, misbranded or contraband and warning all persons
26 not to remove or dispose of such article or articles until
27 permission so to do has been granted by such agent, or until it
28 shall have determined by proper authority that such article or
29 articles are not adulterated, misbranded or contraband. At the
30 time such notice is offered, the agent shall provide the person
19710H0851B0940 - 65 -
1 in charge of such articles, if any, or the owner, if he is
2 known, a statement in writing, setting forth both the basis for
3 the embargo and supporting facts.
4 (b) When an article or articles is detained or embargoed
5 under subsection (a), the secretary shall serve within three
6 days from the date of such embargo a citation upon the claimant
7 thereof or owner, if he is known, setting forth both the basis
8 for the embargo and supporting facts and fixing a date for a
9 hearing not later than ten days from the date of service of said
10 citation at which a hearing examiner, appointed under the
11 authority of section 27, will receive evidence pertaining to the
12 alleged offense. Unless postponed by mutual consent, failure to
13 serve a citation or commence hearings within the time herein
14 specified shall operate to void such embargo.
15 (c) If, after hearing, the examiner is satisfied from the
16 evidence presented that a detained or embargoed article is
17 adulterated, misbranded or contraband, he shall, within five
18 days of the conclusion of the hearing, order such article or
19 articles destroyed at the expense of the claimant thereof under
20 supervision of an agent of the secretary: Provided, That when
21 the embargo is based on an adulteration or misbranding which can
22 be corrected by proper labeling or processing of the article,
23 the examiner, after entry of the order and after such costs,
24 fees and expenses have been paid and a good and sufficient bond
25 conditioned that such article shall be so labeled or processed
26 has been executed, may by order direct that such article be
27 released to the claimant thereof for such labeling or processing
28 under the supervision of an agent of the secretary. The expense
29 of such supervision, if any, shall be paid by the claimant. Such
30 article shall be released to the claimant of the article when
19710H0851B0940 - 66 -
1 the article is no longer in violation of this act and the
2 expenses of such supervision have been paid.
3 (d) If no claimant shall appear to defend such proceedings,
4 the hearing examiner may order the embargoed articles destroyed
5 or distributed to a nonprofit institution.
6 Section 26. Forfeiture.--(a) The following shall be subject
7 to forfeiture to the Commonwealth and no property right shall
8 exist in them:
9 (1) All controlled paraphernalia which have been
10 manufactured, distributed, dispensed, or acquired in violation
11 of this act.
12 (2) All raw materials, products, and equipment of any kind
13 which are used, or intended for use in manufacturing,
14 compounding, processing, delivering, importing, or exporting any
15 controlled substance in violation of this act.
16 (3) All property which is used, or intended for use, as a
17 container for property described in clause (1) or (2) of this
18 subsection.
19 (4) All conveyances, including aircraft, vehicles, or
20 vessels, which are used or are intended for use, to transport,
21 or in any manner to facilitate the transportation, sale,
22 receipt, possession, or concealment of property described in
23 clause (1) or (2) except that:
24 (i) no conveyance used by any person as a common carrier in
25 the transaction of business as a common carrier shall be
26 forfeited under the provisions of this section unless it shall
27 appear that the owner or other person in charge of such
28 conveyance was a consenting party or privy to a violation of
29 this title; and
30 (ii) no conveyance shall be forfeited under the provisions
19710H0851B0940 - 67 -
1 of this section by reason of any act or omission established by
2 the owner thereof to have been committed or omitted without his
3 knowledge or consent.
4 (5) All books, records, and research, including formulas,
5 microfilm, tapes and data which are used, or intended for use,
6 in violation of this act.
7 (b) Property subject to forfeiture under this act may be
8 seized by the law enforcement authority upon process issued by
9 any court of common pleas having jurisdiction over the property.
10 Seizure without process may be made if:
11 (1) The seizure is incident to an arrest or a search under a
12 search warrant or inspection under an administrative inspection
13 warrant;
14 (2) The property subject to seizure has been the subject of
15 a prior judgment in favor of the Commonwealth in a criminal
16 injunction or forfeiture proceeding under this act;
17 (3) There is probable cause to believe that the property is
18 directly or indirectly dangerous to health or safety; or
19 (4) There is probable cause to believe that the property has
20 been used or is intended to be used in violation of this act.
21 (c) In the event seizure without process occurs, as provided
22 herein, proceedings for the issuance thereof shall be instituted
23 promptly.
24 (d) Property taken or detained under this section shall not
25 be subject to replevin, but is deemed to be in the custody of
26 the law enforcement authority subject only to the orders and
27 decrees of the court of common pleas having jurisdiction over
28 the forfeiture proceedings. When property is seized under this
29 act, the law enforcement authority may:
30 (1) Place the property under seal;
19710H0851B0940 - 68 -
1 (2) Remove the property to a place designated by it; or
2 (3) Require that the proper administrative authority take
3 custody of the property and remove it to an appropriate location
4 for disposition in accordance with law.
5 (e) Whenever property is forfeited under this act, the law
6 enforcement authority may:
7 (1) Retain the property for official use;
8 (2) Sell any forfeited property which is not required to be
9 destroyed by law and which is not harmful to the public, but the
10 proceeds from any such sale shall be used to pay all proper
11 expenses of the proceedings for forfeiture and sale including
12 expenses of seizure, maintenance of custody, advertising and
13 court costs;
14 (3) Require that the appropriate administrative agency take
15 custody of the property and remove it for disposition in
16 accordance with law; or
17 (4) Forward it to the council, or its successor agency, for
18 disposition.
19 Section 27. Hearing Examiners.--(a) The secretary shall
20 appoint, with the approval of the Governor, such hearing
21 examiners as shall be necessary to conduct hearings as provided
22 in section 25.
23 (b) Hearing examiners appointed under this act shall have
24 the power to issue subpoenas requiring the attendance and
25 testimony of, or the production of, pertinent books and papers
26 by persons whom they believe to have information relevant to any
27 matter pending before him. Such examiner shall also have the
28 power to administer oaths.
29 (c) Any person who refuses to obey a subpoena issued
30 hereunder or to be sworn or affirmed or to testify, or who is
19710H0851B0940 - 69 -
1 guilty of any contempt after summons to appear, may be punished
2 as for contempt of court. For this purpose, an application may
3 be made by the examiner to the court of common pleas within the
4 territorial jurisdiction of which the offense was committed for
5 which purpose such court is hereby given jurisdiction.
6 (d) In any action or proceeding before him, the hearing
7 examiner may assess all costs incurred in connection with the
8 prosecution of such proceeding, including investigative and
9 laboratory costs incurred by the Commonwealth, against
10 respondent in such proceeding; such costs to be in addition to
11 any other penalty imposed and to be retained by the Department
12 of Health and applied to cost to the department administering
13 this act.
14 (e) Hearings shall be conducted under the provisions of the
15 Administrative Agency Law, as amended, and subject to such other
16 rules and regulations not inconsistent therewith as the
17 secretary may provide and any person aggrieved by any action of
18 the hearing examiner may appeal in accordance with the
19 provisions of the Administrative Agency Law, as amended.
20 Section 28. Board Creation.--(a) There is hereby created
21 within the Department of Health a departmental administrative
22 board to be known as the "Pennsylvania Drug, Device and Cosmetic
23 Board."
24 (b) The board shall consist of the Secretary of Health, his
25 successors in office, and nine additional members whom the
26 Governor shall appoint, by and with the advice and consent of
27 two-thirds of all the members of the Senate. Of the members: one
28 shall be a physician, one a dentist, one a veterinarian, and one
29 a pharmacist, each of whom shall be duly licensed in their
30 respective professions by the Commonwealth; one shall be a
19710H0851B0940 - 70 -
1 biochemist and one shall be a pharmacologist, each of whom shall
2 have earned an advanced degree in that field from an institution
3 of higher learning and shall have been engaged as such for three
4 years in this State; one shall be a manufacturer registered to
5 manufacture drugs or an employe thereof; and the two remaining
6 persons shall be members of the general public not engaged in
7 any of the aforementioned professional fields, who shall be
8 citizens of this State. Two members initially shall serve for
9 terms of one, two, three and four years, respectively, the
10 particular term of each to be designated by the Governor at the
11 time of appointment. Any additional member, the appointment of
12 whom is authorized by amending act, shall serve for a term of
13 four years. The terms of all their successors shall be four
14 years each, except that any person appointed to fill a vacancy
15 shall serve only for the unexpired term. Every member's term
16 shall extend until his successor is appointed and qualified. Any
17 appointed member of the board shall be eligible for
18 reappointment. Each member of the board shall receive
19 compensation at a rate of thirty dollars ($30) per diem in
20 addition to expenses incurred when actually engaged in official
21 meetings or otherwise in the performance of their official
22 duties as directed by the chairman.
23 (c) The Secretary of Health, or his designate, shall serve
24 as chairman of the board. A majority of the members shall
25 constitute a quorum for the purpose of organizing the board,
26 conducting its business, and exercising all of its powers. A
27 vote of the majority of the members present shall be sufficient
28 for all actions of the board unless the bylaws require a greater
29 number.
30 (d) The board shall have the power to prescribe, amend and
19710H0851B0940 - 71 -
1 repeal bylaws, rules and regulations governing the manner in
2 which the business of the body is conducted and the manner in
3 which the powers granted to it are exercised. The board may
4 delegate supervision of the administration of board activities
5 to an administrative secretary and such other employes as the
6 Secretary of Health shall appoint.
7 (e) The board shall have the power to do all things
8 necessary or convenient to carry out the powers granted to it by
9 this act.
10 (f) The board may, for the authentication of its records,
11 process and proceedings, adopt, keep and use a common seal of
12 which seal judicial notice shall be taken in all courts of this
13 Commonwealth and any process, writ, notice or other document,
14 which the board may be authorized by law to issue, shall be
15 deemed sufficient if signed by the chairman or secretary of the
16 board and authenticated by such seal. All acts, proceedings,
17 orders, papers, findings, minutes and records of the board, and
18 all reports and documents filed with the board, may be proved in
19 any court of this Commonwealth by a copy thereof certified to by
20 the chairman or secretary of the board with the seal of the
21 board attached.
22 (g) In order to enable the board to carry out the provisions
23 of this act, including its power to advise the secretary on
24 various matters, it shall have the power to issue subpoenas,
25 requiring the attendance and testimony of, or the production of,
26 pertinent books and papers by persons whom the board believes to
27 have information, books or papers of importance to it in
28 carrying out the purposes and intent of this act. Each member of
29 the board and such officers, employes or others employed in the
30 work of the board designated by the chairman of the board also
19710H0851B0940 - 72 -
1 shall have the power to administer oaths and affirmations, to
2 question witnesses thereunder, and to examine such books and
3 papers. The board may issue commissions, letters rogatory, or
4 other appropriate processes outside the Commonwealth.
5 (h) Any person who refuses to obey a subpoena issued
6 hereunder, or to be sworn or affirmed, or to testify, or who is
7 guilty of any contempt after summons to appear, may be punished
8 as for contempt of court. For this purpose an application may be
9 made by the board to the court of common pleas within the
10 territorial jurisdiction of which the offense was committed, for
11 which purpose, such court is hereby given jurisdiction.
12 Section 29. Persons Authorized to Prescribe Drugs to Remain
13 as Heretofore.--No provision of this act or any rule or
14 regulation promulgated pursuant to this act shall authorize or
15 be construed as authorizing any person to prescribe drugs who is
16 not specifically so authorized under existing law.
17 Section 30. Conformity With Federal Law.--No drug, device or
18 cosmetic shall be deemed to be adulterated or misbranded under
19 this act if such drug, device or cosmetic complies with the
20 applicable Federal act and/or regulations and interpretations
21 issued pursuant thereto, unless the secretary, after
22 consultation with and upon the recommendation of the board,
23 shall have previously promulgated a regulation stating that the
24 applicable provision of the Federal act and/or regulations and
25 interpretations thereof would not be followed.
26 Section 31. Administration of Act.--(a) Except as may be
27 otherwise provided by law, the provisions of this act shall be
28 administered by the Department of Health of the Commonwealth of
29 Pennsylvania. The Secretary of Health is authorized to employ
30 such consultants, assistants, stenographers, clerks and other
19710H0851B0940 - 73 -
1 employes as, in his opinion, may be necessary and to fix their
2 compensation subject to "The Administrative Code of 1929," as
3 amended, act of April 9, 1929 (P.L.177).
4 (b) The secretary is authorized and directed to establish a
5 Bureau of Narcotics Control within the department and to employ
6 therein sufficient law enforcement personnel to act as agents
7 for the purpose of performing the inspection and enforcement
8 duties imposed upon the department by this act.
9 (c) Any officer or employe of the Bureau of Narcotics of the
10 department may:
11 (1) Carry firearms in the performance of his official
12 duties;
13 (2) Execute and serve search warrants, arrest warrants,
14 administrative inspection warrants, subpoenas, and summonses
15 issued under the authority of the Commonwealth;
16 (3) Make arrests without warrant for any offense under this
17 act committed in his presence, or if he has probable cause to
18 believe that the person to be arrested has committed or is
19 committing a violation of this act which may constitute a
20 felony;
21 (4) Make seizures of property pursuant to this act; or
22 (5) Perform other law enforcement duties as the secretary
23 designates.
24 (d) Nothing contained herein shall be deemed to limit the
25 authority of the Department of Justice in dealing with law
26 enforcement matters with respect to professional criminals
27 engaged in the unlawful importation, manufacture, sale and
28 production of drugs and controlled dangerous substances nor the
29 authority of the council in performing any duties imposed upon
30 it by the "Pennsylvania Drug, Narcotic and Alcohol Abuse Act of
19710H0851B0940 - 74 -
1 1971."
2 Section 32. Promulgation of Regulations.--(a) The secretary
3 shall have the authority to promulgate in accordance with the
4 provisions of this section any regulations hereinbefore referred
5 to in this act and such other regulations upon the advice of the
6 board regarding the possession, sale, purchase or manufacture of
7 drugs, devices or cosmetics as may be necessary to aid in the
8 enforcement of this act.
9 (b) (i) Prior to the promulgation, amendment or repeal of
10 any regulation under this act the secretary shall give at least
11 thirty days public notice of his proposed action, and shall
12 afford all interested persons an opportunity to present their
13 views thereon either orally or in writing. As soon as
14 practicable thereafter, the secretary shall either withdraw such
15 proposal or shall promulgate the proposed regulation.
16 (ii) Any person aggrieved by the promulgation, amendment or
17 repeal of a regulation, or by the refusal to promulgate, amend
18 or repeal a regulation, may file objections with the secretary
19 specifying, with particularity, the reason why such action is
20 deemed objectionable and the grounds for such objection. As soon
21 as possible after the filing of objections, the secretary shall
22 hold a public hearing for the purpose of receiving evidence
23 relevant to such objections. As soon as practicable after
24 completion of hearings, the secretary shall issue an appropriate
25 order either confirming, modifying or withdrawing the regulation
26 in question.
27 (iii) Any party to proceedings, conducted pursuant to
28 paragraph (ii) hereof, aggrieved by the order of the secretary,
29 shall have a right of appeal in accordance with the provisions
30 of the Administrative Agency Law, as amended, and such order
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1 shall be deemed an "adjudication" as that term is defined and
2 used in the Administrative Agency Law, as amended.
3 Section 33. Administrative Procedure.--The Administrative
4 Agency Law, as amended, shall be applicable in its entirety to
5 the Department of Health in the administration of this act.
6 Section 34. Savings Provision.--The provisions of this act
7 shall not affect any act done, liability incurred, or right
8 accrued or vested, or affect any suit or prosecution pending to
9 enforce any right or penalty or punish any offense under the
10 authority of any Act of Assembly, or part thereof, repealed by
11 this act.
12 Section 35. Severability.--The provisions of this act are
13 severable and, if any provision or part hereof shall be held
14 invalid or unconstitutional or inapplicable to any person or
15 circumstances, such invalidity, unconstitutionality or
16 inapplicability shall not affect or impair the remaining
17 provisions of the act. It is hereby declared to be the
18 legislative intent that this act would have been adopted if such
19 invalid, unconstitutional or inapplicable provision had not been
20 included therein.
21 Section 36. Repeals.--(a) The act of September 26, 1961
22 (P.L.1664), known as "The Drug, Device and Cosmetic Act," is
23 hereby repealed.
24 (b) All other acts, or parts of acts, inconsistent with this
25 act are hereby repealed.
26 Section 37. Effective Date.--This act shall take effect
27 sixty days after the enactment thereof.
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