PRIOR PRINTER'S NOS. 940, 1546, 2432, PRINTER'S NO. 2698
2510, 2553
No. 851 Session of 1971
Report of the Committee of Conference
To the Members of the Senate and House of Representatives:
We, the undersigned, Committee of Conference on the part of
the Senate and House of Representatives for the purpose of
considering House Bill No. 851, entitled:
"An act relating to the manufacture, sale and possession of
CONTROLLED SUBSTANCES, OTHER drugs, devices and cosmetics;
conferring powers on the courts and the secretary and Department
of Health and a newly created Pennsylvania Drug, Device and
Cosmetic Board; establishing schedules of controlled drugs and <--
dangerous substances; providing penalties; requiring
registration of persons engaged in the drug trade and for the
renovation or suspension of certain licenses and registrations;
and repealing an act."
respectfully submit the following bill as our report:
W. LOUIS COPPERSMITH
LOUIS G. HILL
RICHARD A. SNYDER
(Committee on the part of the Senate.)
MILTON BERKES
MARVIN E. MILLER
EUGENE F. SCANLON
(Committee on the part of the House of Representatives.)
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AN ACT
1 Relating to the manufacture, sale and possession of controlled
2 substances, other drugs, devices and cosmetics; conferring
3 powers on the courts and the secretary and Department of
4 Health and a newly created Pennsylvania Drug, Device and
5 Cosmetic Board; establishing schedules of controlled
6 substances; providing penalties; requiring registration of
7 persons 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 Controlled Substance, Drug, Device and Cosmetic
14 Act."
15 Section 2. Definitions.--(a) The definitions contained and
16 used in the "Pennsylvania Drug and Alcohol Abuse Control Act"
17 shall also apply for purposes of this act.
18 (b) As used in this act:
19 "Administer" means the direct application of a controlled
20 substance, other drug or device, whether by injection,
21 inhalation, ingestion, or any other means, to the body of a
22 patient or research subject.
23 "Advertisement" means any representation, disseminated in any
24 manner or by any means other than by labeling, for the purpose
25 of inducing or which is likely to induce, directly or
26 indirectly, the purchase and/or use of a controlled substance,
27 other drug, device or cosmetic.
28 "Agent" means an authorized person when acting on behalf of
29 or at the direction of a manufacturer, distributor, or
30 dispenser. It does not include a common or contract carrier,
31 public warehouseman, or employe of the carrier or warehouseman.
32 "Board" means the Pennsylvania Drug, Device and Cosmetic
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1 Board.
2 "Bureau" means the Bureau of Drug Control, Pennsylvania
3 Department of Health.
4 "Color additive" means a material which is a dye, pigment or
5 other substance made by a process of synthesis or similar
6 artifice, or extracted, isolated or otherwise derived, with or
7 without intermediate or final change of identity, from a
8 vegetable, animal, mineral or other source, and, when added or
9 applied to a controlled substance, other drug, device or
10 cosmetic to the human or animal body, is capable, alone or
11 through reaction with another substance, of imparting color
12 thereto, except that such term does not include any material
13 which the appropriate authority, pursuant to the Federal act,
14 determines is used or intended to be used solely for a purpose
15 or purposes other than coloring. The term "color" includes
16 black, white and intermediate grays.
17 "Commercial container" means any bottle, jar, tube, ampul, or
18 other receptacle in which a controlled substance, other drug,
19 device or cosmetic is held for distribution or dispensing to an
20 ultimate user, and in addition, any box or package in which the
21 receptacle is held for distribution or dispensing to an ultimate
22 user. The term "commercial container" does not include any
23 package liner, package insert or other material kept with or
24 within a commercial container, nor any carton, crate, drum, or
25 other package in which commercial containers are stored or are
26 used for shipment of controlled substances.
27 "Contaminated with filth" means consisting, in whole or in
28 part, of any decomposed, putrid or filthy substance, or
29 prepared, packed or held under any unsanitary condition or
30 exposed whereby the article or product concerned may have become
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1 contaminated with filth, dirt, dust or any foreign material, or
2 in any manner rendered injurious to health.
3 "Contraband" means any controlled substance, other drug,
4 device or cosmetic possessed by a person not authorized by law
5 to possess such controlled substance, other drug, device or
6 cosmetic, or obtained or held in a manner contrary to the
7 provisions of this act.
8 "Control" means to remove, or change the placement of a
9 controlled substance, or immediate precursor under the
10 provisions of this act.
11 "Controlled substance" means a drug, substance, or immediate
12 precursor included in Schedules I through V of this act.
13 "Cosmetic" means: (i) substances intended to be rubbed,
14 poured, sprinkled or sprayed on, introduced into or otherwise
15 applied to the human body or other animal body or any part
16 thereof for cleansing, beautifying, promoting attractiveness or
17 altering the appearance, and (ii) substances intended for use as
18 a component of any such substances, except that such term shall
19 not include soap.
20 "Council" means the Governor's Council on Drug and Alcohol
21 Abuse.
22 "Counterfeit" means a controlled substance, other drug,
23 device or cosmetic which, or the container or labeling of which,
24 without authorization, bears the trademark, trade name, or other
25 identifying mark, imprint, number, or device, or any likeness
26 thereof, of a manufacturer, distributor, or dispenser other than
27 the person or persons who in fact manufactured, distributed, or
28 dispensed such substance and which thereby is falsely purported
29 or represented to be the product of, or to have been distributed
30 by, such other manufacturer, distributor, or dispenser.
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1 "Court" means all courts of the Commonwealth of Pennsylvania,
2 including magistrates and justices of the peace.
3 "Deliver" or "delivery" means the actual, constructive, or
4 attempted transfer from one person to another of a controlled
5 substance, other drug, device or cosmetic whether or not there
6 is an agency relationship.
7 "Department" means the Department of Health of the
8 Commonwealth of Pennsylvania.
9 "Device" means instruments, apparatus and contrivances,
10 including their components, parts and accessories, intended: (i)
11 for use in the diagnosis, cure, mitigation, treatment or
12 prevention of disease of man or other animals; or (ii) to affect
13 the structure or any function of the body of man or other
14 animals.
15 "Dispense" means to deliver a controlled substance, other
16 drug or device to an ultimate user or research subject by or
17 pursuant to the lawful order of a practitioner, including the
18 prescribing, administering, packaging, labeling, or compounding
19 necessary to prepare such item for that delivery.
20 "Dispenser" means a practitioner who dispenses.
21 "Distribute" means to deliver other than by administering or
22 dispensing a controlled substance, other drug, device or
23 cosmetic.
24 "Distributor" means any person engaged in the activities of
25 jobber, dealer, or wholesaler who sells, or otherwise
26 distributes, any controlled substance, other drug, device or
27 cosmetic for resale or redistribution which he has not himself
28 prepared, produced or compounded.
29 "Drug" means: (i) substances recognized in the official
30 United States Pharmacopeia, or official National Formulary, or
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1 any supplement to either of them; and (ii) substances intended
2 for use in the diagnosis, cure, mitigation, treatment or
3 prevention of disease in man or other animals; and (iii)
4 substances (other than food) intended to affect the structure or
5 any function of the human body or other animal body; and (iv)
6 substances intended for use as a component of any article
7 specified in clause (i), (ii) or (iii), but not including
8 devices or their components, parts or accessories.
9 "Drug dependent person" means a person who is using a drug,
10 controlled substance or alcohol, and who is in a state of
11 psychic or physical dependence, or both, arising from
12 administration of that drug, controlled substance or alcohol on
13 a continuing basis. Such dependence is characterized by
14 behavioral and other responses which include a strong compulsion
15 to take the drug, controlled substance or alcohol on a
16 continuous basis in order to experience its psychic effects, or
17 to avoid the discomfort of its absence. This definition shall
18 include those persons commonly known as "drug addicts."
19 "Immediate precursor" means a substance which the secretary
20 has found to be and by regulation designates as being a
21 principal compound commonly used or produced primarily for use,
22 and which is an immediate chemical intermediary used or likely
23 to be used in the manufacture of a controlled substance.
24 "Label" means a display of written, printed or graphic matter
25 upon the commercial container of any substance or article and a
26 requirement made by or under authority of this act that any
27 word, statement or other information appearing on the label
28 shall not be considered to be complied with unless such word,
29 statement or other information also appears on the outside
30 container or wrapper, if any there be, of the retail package of
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1 such substance or is easily legible through the outside
2 container or wrapper.
3 "Labeling" means all labels and other written, printed, or
4 graphic matter: (i) upon a substance or any of its containers or
5 wrappers; or (ii) accompanying such substance.
6 "Manufacture" means the production, preparation, propagation,
7 compounding, conversion or processing of a controlled substance,
8 other drug or device or the packaging or repackaging of such
9 substance or article, or the labeling or relabeling of the
10 commercial container of such substance or article, but does not
11 include the activities of a practitioner who, as an incident to
12 his administration or dispensing such substance or article in
13 the course of his professional practice, prepares, compounds,
14 packages or labels such substance or article. The term
15 "manufacturer" means a person who manufactures a controlled
16 substance, other drug or device.
17 "Marihuana" means all parts of the plant Cannabis sativa L.,
18 whether growing or not; the seeds thereof; the resin extracted
19 from any part of such plant; and every compound, manufacture,
20 salt, derivative, mixture, or preparation of such plant, its
21 seeds or resin; but shall not include tetrahydrocannabinols, the
22 mature stalks of such plant, fiber produced from such stalks,
23 oil or cake made from the seeds of such plant, any other
24 compound, manufacture, salt, derivative, mixture, or preparation
25 of such mature stalks (except the resin extracted therefrom),
26 fiber, oil, cake, or the sterilized seed of such plant which is
27 incapable of germination.
28 "Narcotic" means any of the following, whether produced
29 directly or indirectly by extraction from substances of
30 vegetable origin, or independently by means of chemical
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1 synthesis or by a combination of extraction and chemical
2 synthesis: (i) opium, (ii) any opiate having an addiction-
3 forming or addiction-sustaining capacity similar to morphine,
4 but not including the isoquinoline alkaloids of opium, (iii) any
5 compound, manufacture, salt, derivative, or preparation of opium
6 or any opiate, and (iv) any substance, compound, manufacture,
7 salt, derivative, or preparation thereof, which is chemically
8 identical with any of the substances referred to in (i), (ii) or
9 (iii).
10 "New drug" means (i) any drug the composition of which is
11 such that such drug is not generally recognized among experts
12 qualified by scientific training and experience to evaluate the
13 safety and effectiveness of drugs as safe and effective for use
14 under the conditions prescribed, recommended or suggested in the
15 labeling thereof; or (ii) any drug the composition of which is
16 such that such drug, as a result of investigations to determine
17 its safety and effectiveness for use under such conditions, has
18 become so recognized, but which has not, otherwise than in such
19 investigations, been used to a material extent or for a material
20 time under such conditions.
21 "Nonproprietary drug" means any drug containing any quantity
22 of any controlled substance or any drug requiring a
23 prescription, a drug containing biologicals or substances of
24 glandular origin (except intestinal enzymes and all liver
25 products), drugs which are administered parenterally, but not
26 any such drugs which are prepackaged with complete dosage
27 instructions in the labeling limiting their use to the care or
28 treatment of poultry and livestock.
29 "Official compendium" means the official United States
30 Pharmacopeia, the official National Formulary or any supplement
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1 to either of them.
2 "Opiate" means any substance having an addiction-forming or
3 addiction-sustaining liability similar to morphine or being
4 capable of conversion into a drug having addiction-forming or
5 addiction-sustaining liability. It does not include the
6 dextrorotatory isomer of 3-methoxy-n-methlmorphinan and its
7 salts (dextromethorphan). It does include the racemic and
8 levorotatory forms.
9 "Opium poppy" means the plant of the species Papaver
10 somniferum L., except its seeds.
11 "Person" means individual, corporation, government or
12 governmental subdivision or agency, business trust, estate,
13 trust, partnership or association, or any other legal entity.
14 "Poppy straw" means all parts, except the seeds, of the opium
15 poppy, after mowing.
16 "Practitioner" means: (i) a physician, osteopath, dentist,
17 veterinarian, pharmacist, podiatrist, nurse, scientific
18 investigator, or other person licensed, registered or otherwise
19 permitted to distribute, dispense, conduct research with respect
20 to or to administer a controlled substance, other drug or device
21 in the course of professional practice or research in the
22 Commonwealth of Pennsylvania; (ii) a pharmacy, hospital, clinic
23 or other institution licensed, registered, or otherwise
24 permitted to distribute, dispense, conduct research with respect
25 to or to administer a controlled substance, other drug or device
26 in the course of professional practice or research in the
27 Commonwealth of Pennsylvania.
28 "Production" includes the manufacture, planting, cultivation,
29 growing or harvesting of a controlled substance, other drug,
30 device and cosmetic.
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1 "Prescription" or "prescription order" means an order for a
2 controlled substance, other drug or device for medication which
3 is dispensed to or for an ultimate user but does not include an
4 order for a controlled substance, other drug or device for
5 medication which is dispensed for immediate administration to
6 the ultimate user. (e.g., an order to dispense a drug to a bed
7 patient for immediate administration in a hospital is not a
8 prescription order.)
9 "Registrant" means any one person registered under the laws
10 of this Commonwealth to manufacture, dispense, distribute,
11 administer or sell drugs.
12 "Secretary" means the Secretary of Health of the Commonwealth
13 of Pennsylvania.
14 "Ultimate user" means a person who lawfully possesses a
15 controlled substance, other drug, device or cosmetic for his own
16 use or for the use of a member of his household or for
17 administering to an animal in his care.
18 Section 3. Authority to Control.--(a) The secretary shall
19 control all substances listed in Schedules I through V of this
20 act and may, by regulation, upon his own motion or on the
21 petition of any interested party add a substance as a controlled
22 substance. Such regulations shall be adopted in accordance with
23 the act of July 31, 1968 (Act No. 240), known as the
24 "Commonwealth Documents Law." Before so doing, the secretary
25 shall request the advice in writing from the board whether a
26 substance should be added as a controlled substance. Such advice
27 shall be rendered to the secretary within a reasonable time. The
28 secretary shall consider with respect to each substance
29 hereafter controlled:
30 (1) Its actual or relative potential for abuse;
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1 (2) Scientific evidence of its pharmacological effect, if
2 known;
3 (3) State of current scientific knowledge regarding the
4 substance;
5 (4) Its history and current pattern of abuse;
6 (5) The scope, duration, and significance of abuse;
7 (6) The risk there is to the public health;
8 (7) Its psychic or physiological dependence liability;
9 (8) Whether the substance is controlled under Federal law;
10 and
11 (9) Whether the substance is an immediate precursor of a
12 substance already controlled under this section. After
13 considering the above factors, the secretary shall make findings
14 with respect thereto and shall issue a regulation controlling
15 the substance if he finds that the substance has a potential for
16 abuse.
17 (b) If the secretary designates a substance as an immediate
18 precursor, substances which are precursors of the controlled
19 precursor shall not be subject to control solely because they
20 are precursors of the controlled precursor.
21 (c) The secretary shall not remove any substance from
22 control under this act unless specifically authorized by the
23 General Assembly to do so. The secretary shall not reschedule
24 any controlled substance unless specifically authorized by the
25 board to do so.
26 Section 4. Schedules of Controlled Substances.--The
27 following schedules include the controlled substances listed or
28 to be listed by whatever official name, common or usual name,
29 chemical name, or trade name designated.
30 (1) Schedule I--In determining that a substance comes within
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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 substances are included in this
5 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. Alphacetylmethadol.
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. Diethylthiambutene.
26 16. Dimenoxadol.
27 17. Dimepheptanol.
28 18. Dimethylthiambutene.
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. Mescaline.
5 11. Peyote.
6 12. N-ethyl-3-piperidyl benzilate.
7 13. N-methyl-3-piperidyl benzilate.
8 14. Psilocybin.
9 15. Psilocyn.
10 16. Tetrahydrocannabinols.
11 (iv) Marihuana.
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 substances are included in this schedule:
18 (i) Any of the following substances except those narcotics
19 specifically excepted or listed in other schedules, whether
20 produced directly or indirectly by extraction from substances of
21 vegetable origin, or independently by means of chemical
22 synthesis, or by combination of extraction and chemical
23 synthesis:
24 1. Opium and opiate, and any salt, compound, derivative, or
25 preparation of opium or opiate.
26 2. Any salt, compound, derivative, or preparation thereof
27 which is chemically equivalent or identical with any of the
28 substances referred to in subclause 1, except that these
29 substances shall not include the isoquinoline alkaloids of
30 opium.
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1 3. Opium poppy and poppy straw.
2 4. Coca leaves and any salt, compound, derivative, or
3 preparation of coca leaves, and any salt, compound, derivative,
4 or preparation thereof which is chemically equivalent or
5 identical with any of these substances, but shall not include
6 decocainized coca leaves or extracts of coca leaves, which
7 extracts do not contain cocaine or ecgonine.
8 (ii) Any of the following opiates, including their isomers,
9 esters, ethers, salts, and salts of isomers, esters and ethers,
10 unless specifically excepted or listed in another schedule,
11 whenever the existence of such isomers, esters, ethers and salts
12 is possible within the specific chemical designation:
13 1. Alphaprodine.
14 2. Anileridine.
15 3. Bezitramide.
16 4. Dihydrocodeine.
17 5. Diphenoxylate.
18 6. Fentanyl.
19 7. Isomethadone.
20 8. Levomethorphan.
21 9. Levorphanol.
22 10. Metazocine.
23 11. Methadone.
24 12. Methadone-Intermediate, 4-cyano-2-dimethylamino-4,4-
25 diphenyl butane.
26 13. Moramide-Intermediate, 2-methyl-3-morpholino-1, 1-
27 diphenyl-propane-carboxylic acid.
28 14. Pethidine.
29 15. Pethidine-Intermediate-A, 4-cyano-1-methyl-4-
30 phenylpiperidine.
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1 16. Pethidine-Intermediate-B, ethyl-4-phenylpiperidine-4-
2 carboxylate.
3 17. Pethidine-Intermediate-C, 1-methyl-4-phenylpiperidine-4-
4 carboxylic acid.
5 18. Phenazocine.
6 19. Piminodine.
7 20. Racemethorphan.
8 21. Racemorphan.
9 (iii) Unless specifically excepted or unless listed in
10 another schedule, any material, compound, mixture or preparation
11 which contains any quantity of the following substances, having
12 a potential for abuse associated with the stimulant effect on
13 the central nervous system:
14 1. Amphetamine, its salts, optical isomers, and salts of its
15 optical isomers.
16 2. Phenmetramine and its salts.
17 3. Methylphenidate.
18 4. Any substance which contains any quantity of
19 methamphetamine including its salts, isomers and salts of
20 isomers.
21 (iv) The phrase "opiates" as used in section 4 of this act
22 and elsewhere throughout the act shall not include the
23 dextrorotatory isomer of 3-methoxy-n-methylmorphinan and its
24 salts, but does include its racemic and levorotatory forms.
25 (3) Schedule III--In determining that a substance comes
26 within this schedule, the secretary shall find: a potential for
27 abuse less than the substances listed in Schedules I and II;
28 well documented and currently accepted medical use in the United
29 States; and abuse may lead to moderate or low physical
30 dependence or high psychological dependence. The following
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1 classes of controlled substances are included in this schedule:
2 (i) Any material, compound, mixture, or preparation unless
3 specifically excepted or unless listed in another schedule which
4 contains any quantity of the following substances having a
5 potential for abuse associated with a depressant effect on the
6 central nervous system:
7 1. Any substance which contains any quantity of a derivative
8 of barbituric acid, or any salt of a derivative of barbituric
9 acid.
10 2. Chorhexadol.
11 3. Glutethimide.
12 4. Lysergic acid.
13 5. Lysergic acid amide.
14 6. Methyprylon.
15 7. Phencyclidine.
16 8. Sulfondiethylmethane.
17 9. Sulfonethylmethane.
18 10. Sulfonmethane.
19 (ii) Nalorphine.
20 (iii) Any material, compound, mixture, or preparation
21 containing limited quantities of the following narcotic drugs,
22 or any salts thereof, unless specifically excepted or listed in
23 other schedules:
24 1. Not more than 1.8 grams of codeine per 100 milliliters or
25 not more than 90 milligrams per dosage unit, with an equal or
26 greater quantity of an isoquinoline alkaloid of opium.
27 2. Not more than 1.8 grams of codeine per 100 milliliters or
28 not more than 90 milligrams per dosage unit, with one or more
29 active, nonnarcotic ingredients in recognized therapeutic
30 amounts.
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1 3. Not more than 300 milligrams of dihydrocodeinone per 100
2 milliliters or not more than 15 milligrams per dosage unit, with
3 a fourfold or greater quantity of an isoquinoline alkaloid of
4 opium.
5 4. Not more than 300 milligrams of dihydrocodeinone per 100
6 milliliters or not more than 15 milligrams per dosage unit, with
7 one or more active, nonnarcotic ingredients in recognized
8 therapeutic amounts.
9 5. Not more than 1.8 grams of dihydrocodeine per 100
10 milliliters or not more than 90 milligrams per dosage unit, with
11 one or more active, nonnarcotic ingredients in recognized
12 therapeutic amounts.
13 6. Not more than 300 milligrams of ethylmorphine per 100
14 milliliters or not more than 15 milligrams per dosage unit, with
15 one or more active, nonnarcotic ingredients in recognized
16 therapeutic amounts.
17 7. Not more than 500 milligrams of opium per 100 milliliters
18 or per 100 grams, or not more than 25 milligrams per dosage
19 unit, with one or more active, nonnarcotic ingredients in
20 recognized therapeutic amounts.
21 8. Not more than 50 milligrams of morphine per 100
22 milliliters or per 100 grams and not more than 2.5 milligrams
23 per dosage unit with one or more active, nonnarcotic ingredients
24 in recognized therapeutic amounts.
25 (v) The secretary may by regulation except any compound,
26 mixture, or preparation containing any drug or controlled
27 substance listed in subclauses (i) and (ii) of this schedule
28 above from the application of those provisions of this act
29 covering controlled substances, if the compound, mixture, or
30 preparation contains one or more active medicinal ingredients
19710H0851B2698 - 19 -
1 not having a stimulant or depressant effect on the central
2 nervous system: Provided, That such admixtures shall be included
3 therein in such combinations, quantity, proportion, or
4 concentration as to vitiate the potential for abuse of the
5 substances which do have a stimulant or depressant effect on the
6 central nervous system.
7 (vi) The secretary shall by regulation exempt any
8 nonnarcotic substance from the control under this act if such
9 substance may, under the provisions of the Federal Food, Drug,
10 and Cosmetic Act (21 U.S.C. 301 et seq.), be lawfully sold over
11 the counter without a prescription.
12 (4) Schedule IV--In determining that a substance comes
13 within this schedule, the secretary shall find: a low potential
14 for abuse relative to substances in Schedule III; currently
15 accepted medical use in the United States; and limited physical
16 and/or psychological dependence liability relative to the
17 substances listed in Schedule III. The following controlled
18 substances are included in this schedule:
19 (i) Any material, compound, mixture, or preparation, unless
20 specifically excepted or unless listed in another schedule,
21 which contains any quantity of the following substances having a
22 potential for abuse associated with a depressant effect on the
23 central nervous system:
24 1. Barbital.
25 2. Chloral betaine.
26 3. Chloral hydrate.
27 4. Ethchlorvynol.
28 5. Ethinamate.
29 6. Methohexital.
30 7. Meprobamate.
19710H0851B2698 - 20 -
1 8. Methylphenobarbital.
2 9. Paraldehyde.
3 10. Petrichloral.
4 11. Phenobarbital.
5 (ii) The secretary may by regulation except any compound,
6 mixture, or preparation containing any drug or controlled
7 dangerous substance listed in subclause (i) of this schedule
8 above from the application of those provisions of this act
9 covering controlled drugs, if the compound, mixture, or
10 preparation contains one or more active medicinal ingredients
11 not having a stimulant or depressant effect on the central
12 nervous system: Provided, That such admixtures shall be included
13 therein in such combinations, quantity, proportion, or
14 concentration as to vitiate the potential for abuse of the
15 substances which do have a stimulant or depressant effect on the
16 central nervous system.
17 (iii) The secretary shall by regulation exempt any
18 nonnarcotic substance from the control under this act if such
19 substance may, under the provisions of the Federal Food, Drug,
20 and Cosmetic Act (21 U.S.C. 301 et seq.), be lawfully sold over
21 the counter without a prescription.
22 (5) Schedule V--In determining that a substance comes within
23 this schedule, the secretary shall find: a low potential for
24 abuse relative to the substances listed in Schedule IV;
25 currently accepted medical use in the United States; and limited
26 physical dependence and/or psychological dependence liability
27 relative to the substances listed in Schedule IV. The following
28 controlled substances are included in this schedule:
29 (i) Any compound, mixture, or preparation containing limited
30 quantities of any of the following narcotics or any of their
19710H0851B2698 - 21 -
1 salts, which shall include one or more nonnarcotic active
2 medicinal ingredients in sufficient proportion to confer upon
3 the compound, mixture, or preparation, valuable medicinal
4 qualities other than those possessed by the narcotic alone:
5 1. Not more than 200 milligrams of codeine, or any of its
6 salts, per 100 milliliter or per 100 grams and not more than 10
7 milligrams per dosage unit.
8 2. Not more than 100 milligrams of dihydrocodeine, or any of
9 its salts, per 100 milliliters or per 100 grams and not more
10 than 5 milligrams per dosage unit.
11 3. Not more than 100 milligrams of ethylmorphine, or any of
12 its salts, per 100 milliliters or per 100 grams and not more
13 than 5 milligrams per dosage unit.
14 4. Not more than 2.5 milligrams of diphenoxylate and not
15 less than 25 micrograms of atropine sulfate per dosage unit.
16 5. Not more than 100 milligrams of opium per 100 milliliters
17 or per 100 grams, or not more than 5 milligrams per dosage unit.
18 Section 5. Exempt Controlled Substances, Other Drugs,
19 Devices and Cosmetics.--(a) Except as set forth in the Schedules
20 of Controlled Substances of section 4 of this act or otherwise
21 provided herein, the secretary, after consultation with and upon
22 the recommendation of the board, may, by regulation, exempt from
23 the provisions of this act relating to controlled substances,
24 other drugs, devices and cosmetics to such extent as he
25 determines to be consistent with the public health.
26 Section 6. Registration.--(a) No person shall operate within
27 this Commonwealth as a manufacturer, distributor or retailer of
28 controlled substances, other drugs and devices nor sell, offer
29 for sale nor solicit the purchase of controlled substances,
30 other drugs and devices nor hold them for sale or resale until
19710H0851B2698 - 22 -
1 such person has registered under this act with the secretary.
2 Such registration must be renewed annually in accordance with
3 rules and regulations relating thereto.
4 (1) Any manufacturer or distributor not operating an
5 establishment within this Commonwealth, but employing sales
6 representatives or agents within this Commonwealth, shall either
7 register as a manufacturer or distributor as the case may be, or
8 file, in lieu of registration, with the secretary the names and
9 addresses of such representatives and agents, and shall promptly
10 inform the secretary of any changes in said list.
11 (2) Separate registration with the secretary shall be
12 required annually for each place at which such person carries on
13 activities as a manufacturer, distributor or retailer within
14 this Commonwealth. The certificate evidencing such registration
15 shall be conspicuously displayed and shall not be transferable.
16 (3) Registrations issued by the secretary or under the law
17 preceding this act to manufacturers, distributors or retailers
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 registration issued pursuant to this section. Nothing
21 contained herein shall be construed to require the registration
22 hereunder of any practitioner registered or licensed by the
23 appropriate State board, nor to require the separate
24 registration of agents or employes of persons registered
25 pursuant to the provisions of this section, or of sales
26 representatives or agents of manufacturers or distributors not
27 operating an establishment within this Commonwealth whose names
28 and addresses are on file with the secretary: Provided,
29 however, That all persons registered pursuant to this section,
30 whether located within this Commonwealth or not, shall be deemed
19710H0851B2698 - 23 -
1 to have accepted and shall be subject to all provisions of this
2 act.
3 (b) No person shall operate as a manufacturer of controlled
4 substances or other drugs unless they 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 controlled substances, or other drugs or such other person
8 approved by the secretary as qualified by scientific or
9 technical training or experience to perform such duties of
10 supervision as may be necessary to protect the public health and
11 safety.
12 (c) Each application for registration as a manufacturer,
13 distributor or retailer shall be accompanied by a fee to be set
14 by the secretary. Applications shall be on forms prescribed by
15 the secretary. Registration shall be renewed annually and
16 applications therefor shall be accompanied by the same fee as
17 for initial applications.
18 (d) Initial registration shall become effective at noon on
19 the sixtieth day after application therefor is filed: Provided,
20 however, That the secretary shall have authority to issue a
21 registration or to issue an order denying such registration
22 pursuant to subsection (e) hereof at any time prior to the
23 expiration of such sixty day period. Renewal of registration
24 shall be effective upon certification by the secretary that the
25 applicant has met all requirements for such renewal.
26 (e) The secretary may refuse the initial registration and
27 may, after notice and hearing pursuant to the Administrative
28 Agency Law, suspend registration (i) of any person who has made
29 material false representation in the application for
30 registration; (ii) of any manufacturer or distributor who has
19710H0851B2698 - 24 -
1 been convicted of a violation of any law of this Commonwealth or
2 of the United States relating to controlled substances, if such
3 refusal shall be necessary for the protection of the public
4 health and safety; (iii) of any manufacturer or distributor who
5 knowingly employs in a capacity directly connected with the
6 preparation, handling or sale of controlled substances any
7 person convicted of a violation of the laws of this Commonwealth
8 or of the United States relating to the sale, use or possession
9 of controlled substances, if such refusal shall be necessary for
10 the protection of the public health and safety.
11 (f) If the secretary takes any action refusing registration
12 or revoking or suspending registration under subsections (e) and
13 (f), the aggrieved party may, within fifteen days after the date
14 upon which a copy of the order is delivered to the address
15 indicated on the application or the registration whichever is
16 applicable, petition the board for review. The board shall,
17 within thirty days, grant a hearing and, as soon thereafter as
18 practicable, adopt, modify or reject the action of the
19 secretary. Any action by the board shall be deemed an
20 adjudication to which the provisions of the Administrative
21 Agency Law, as amended, shall be applicable.
22 (g) The following persons need not register and may lawfully
23 possess controlled substances under this act:
24 (1) an agent or employe of any registered manufacturer,
25 distributor, dispenser or any person listed in lieu of
26 registration with the secretary if he is acting in the usual
27 course of his business or employment;
28 (2) a common or contract carrier or warehouseman, or an
29 employe thereof, whose possession of any controlled substance is
30 in the usual course of business or employment;
19710H0851B2698 - 25 -
1 (3) an ultimate user or a person in possession of any
2 controlled substance pursuant to a lawful order of a
3 practitioner or in lawful possession of a Schedule V substance.
4 Section 7. Adulteration.--A controlled substance, other
5 drug, device or cosmetic shall be deemed to be adulterated:
6 (1) (i) If it consists, in whole or in part, of any filthy,
7 putrid or decomposed substance; (ii) if it has been prepared,
8 packed or held under unsanitary conditions whereby it may have
9 been contaminated with filth, or whereby it may have been
10 rendered injurious to health; (iii) and if it is a drug or a
11 device its container is composed, in whole or in part, of any
12 poisonous or deleterious substance which may render the contents
13 injurious to health; (iv) if it has been exposed to conditions
14 of fire, water or extreme temperature, which may have rendered
15 it injurious to health; (v) if (A) it bears or contains for
16 purposes of coloring only a color additive, unless it be a hair
17 dye which is unsafe within the meaning of section 9 of this act,
18 or (B) it is a color additive the intended use of which in or on
19 drugs, devices or cosmetics is for purposes of coloring only and
20 is unsafe, unless it be a hair dye within the meaning of section
21 9 of this act.
22 (2) If it purports to be or is represented as a drug or
23 device, the name of which is recognized in an official
24 compendium and its strength differs from or its quality or
25 purity falls below the standards set forth in such compendium.
26 Such determination as to strength, quality or purity, shall be
27 made in accordance with the tests or methods of assay set forth
28 in such compendium, or in the absence of or inadequacy of such
29 tests or methods of assay those prescribed under the authority
30 of the Federal act. No drug or device defined in an official
19710H0851B2698 - 26 -
1 compendium shall be deemed to be adulterated under this
2 subsection because it differs from the standard of strength,
3 quality or purity therefor set forth in such compendium, if its
4 difference in strength, quality or purity from such standard is
5 plainly stated on its label.
6 (3) If it is a color additive and is to be used or is
7 recommended for use as a hair dye and it is not exempt under
8 section 9 unless its label bears the following legend
9 conspicuously displayed thereon: "Caution. This product contains
10 ingredients which may cause skin irritation on certain
11 individuals and a preliminary test according to accompanying
12 directions should first be made. This product must not be used
13 for dyeing the eyelashes or eyebrows, to do so may cause
14 blindness," and the labeling bears adequate directions for such
15 preliminary testing. For the purpose of this paragraph, the term
16 "hair dye" shall not include eyelash dyes or eyebrow dyes.
17 (4) If it is not subject to the provisions of clause (2) of
18 this section and its strength differs from or its purity or
19 quality falls below that which it purports or is represented to
20 possess.
21 (5) If it is a drug or device and any substance has been (i)
22 mixed or packed therewith so as to reduce its quality or
23 strength, or (ii) substituted wholly or in part therefor.
24 Section 8. Misbranding.--A controlled substance, other drug
25 or device or cosmetic shall be deemed to be misbranded:
26 (1) If its labeling is false or misleading in any
27 particular.
28 (2) If in package form unless it bears a label containing
29 (i) the name and place of business of the manufacturer, packer
30 or distributor, and (ii) an accurate statement of the quantity
19710H0851B2698 - 27 -
1 of the contents in terms of weight measure or numerical count:
2 Provided, That under subclause (ii) of this clause, reasonable
3 variations shall be permitted and exemptions as to small
4 packages shall be established by regulations.
5 (3) If any word, statement or other information required by
6 or under authority of this act to appear on the label, or
7 labeling is not prominently placed thereon with such
8 conspicuousness (as compared with other words, statements,
9 designs or devices in the labeling), and in such terms as to
10 render it likely to be read and understood by the ordinary
11 individual under customary conditions of purchase and use.
12 (4) If it is for use by man and is a controlled substance
13 designated by Federal law as habit-forming, unless its label
14 bears the statement "Warning. 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 glycosides, 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
19710H0851B2698 - 28 -
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, device or cosmetic is not necessary for the
8 protection of the public health, regulations shall be
9 promulgated exempting such drug, device or cosmetic from such
10 requirements.
11 (7) If it purports to be a drug or device the name of which
12 is recognized in an official compendium, unless it is packaged
13 and labeled as prescribed therein: Provided, That the method of
14 packaging may be modified with a consent of the secretary.
15 (8) If it has been found by the secretary to be a drug,
16 device or cosmetic liable to deterioration unless it is packaged
17 in such form and manner and its label bears a statement
18 specifying such precautions against deterioration as the
19 secretary shall by regulation require as necessary for the
20 protection of public health.
21 (9) If it is offered for sale or sold under the name of
22 another drug, device or cosmetic or brand of drug, device or
23 cosmetic, or if it is manufactured, packaged, labeled or sold in
24 such manner as to give rise to a reasonable probability that the
25 purchaser will be led to believe he is purchasing such drug,
26 device or cosmetic as another drug, device or cosmetic or as the
27 product of another manufacturer.
28 (10) If it is dangerous to health when used in the dosage or
29 with the frequency or duration prescribed, recommended or
30 suggested in the labeling thereof.
19710H0851B2698 - 29 -
1 (11) If it is a drug, device or cosmetic and its container
2 is so made, formed or filled as to be misleading.
3 (12) If it is a controlled substance its commercial
4 container must bear a label containing an identifying symbol for
5 such substance in accordance with Federal regulations.
6 Section 9. Color Additives.--A color additive shall be
7 deemed unsafe unless there is in effect with respect to such
8 additive a regulation issued pursuant to the Federal act
9 permitting such use and unless such additive and use thereof
10 conforms in all respects to the requirements of the Federal act
11 and regulations issued pursuant thereto.
12 Section 10. New Drugs.--No person shall sell, deliver, offer
13 for sale, hold for sale, or give away, any new drug unless (i)
14 an application with respect thereto has been approved or a
15 notice of claimed investigational exemption for a new drug has
16 been filed under the appropriate Federal act.
17 Section 11. Professional Prescription, Administration, and
18 Dispensing.--(a) Except when dispensed or administered directly
19 to the patient by a practitioner or his authorized agent, other
20 than a pharmacist, to an ultimate user, no controlled substance
21 in Schedule II, may be dispensed without the written
22 prescription of a practitioner, except in emergency situations,
23 as prescribed by the secretary by regulation. No prescription
24 for a controlled substance in Schedule II may be refilled.
25 (b) Except when dispensed directly by a practitioner, other
26 than a pharmacist, to an ultimate user, no controlled substance
27 in Schedule III or IV, may be dispensed without a written or
28 oral prescription. Such prescriptions shall not be filled or
29 refilled more than six months after the date thereof or be
30 refilled more than five times after the date of the prescription
19710H0851B2698 - 30 -
1 unless renewed by the practitioner.
2 (c) No controlled substance in Schedule V may be distributed
3 or dispensed for other than a medicinal purpose.
4 (d) A practitioner may prescribe, administer, or dispense a
5 controlled substance or other drug or device only (i) in good
6 faith in the course of his professional practice, (ii) within
7 the scope of the patient relationship, and (iii) in accordance
8 with treatment principles accepted by a responsible segment of
9 the medical profession. A practitioner may cause a controlled
10 substance, other drug or device or drug to be administered by a
11 professional assistant under his direction and supervision.
12 (e) A veterinarian may prescribe, administer, or dispense a
13 controlled substance, other drug or device only (i) in good
14 faith in the course of his professional practice, and (ii) not
15 for use by a human being. He may cause a controlled substance,
16 other drug or device to be administered by a professional
17 assistant under his direction and supervision.
18 (f) Any drug or device dispensed by a pharmacist pursuant to
19 a prescription order shall bear a label showing (i) the name and
20 address of the pharmacy and any registration number obtained
21 pursuant to any applicable Federal laws, (ii) the name of the
22 patient, or, if the patient is an animal, the name of the owner
23 of the animal and the species of the animal, (iii) the name and
24 any registration number required to be obtained pursuant to any
25 applicable Federal laws, of the practitioner by whom the
26 prescription order was written, and (iv) the serial number and
27 date of filing of the prescription order. In addition, the
28 following statement shall be required on the label of a
29 controlled substance: "Transfer of this drug to anyone other
30 than the patient for whom it was prescribed is illegal."
19710H0851B2698 - 31 -
1 Section 12. Records of Distribution of Controlled
2 Substances.--(a) Every person who sells or otherwise distributes
3 controlled substances, shall keep records of all purchases or
4 other receipt and sales or other distribution of such substances
5 for two years from the date of purchase or sale. Such records
6 shall include the name and address of the person from whom
7 purchased or otherwise received or to whom sold or otherwise
8 distributed, the date of purchase or receipt or sale or
9 distribution, and the quantity involved: Provided, however, That
10 this subsection shall not apply to a practitioner who dispenses
11 controlled substances to his patients, unless the practitioner
12 is regularly engaged in charging his patients, whether
13 separately or together with charges for other professional
14 services, for substances so dispensed.
15 (b) Every practitioner licensed by law to administer,
16 dispense or distribute controlled substances shall keep a record
17 of all such substances administered, dispensed or distributed by
18 him, showing the amount administered, dispensed or distributed,
19 the date, the name and address of the patient, and in the case
20 of a veterinarian, the name and address of the owners of the
21 animal to whom such substances are dispensed or distributed.
22 Such record shall be kept for two years from the date of
23 administering, dispensing or distributing such substance and
24 shall be open for inspection by the proper authorities.
25 (c) Persons registered or licensed to manufacture or
26 distribute or dispense a controlled substance, other drug or
27 device under this act shall keep records and maintain
28 inventories in conformity with the record-keeping, order form
29 and inventory requirements of Federal law and with any
30 additional regulations the secretary issues. Controlled
19710H0851B2698 - 32 -
1 substances in Schedules I and II shall be distributed by a
2 registrant to another registrant only pursuant to an order form.
3 Section 13. Prohibited Acts; Penalties.--(a) The following
4 acts and the causing thereof within the Commonwealth are hereby
5 prohibited:
6 (1) The manufacture, sale or delivery, holding, offering for
7 sale, or possession of any controlled substance, other drug,
8 device or cosmetic that is adulterated or misbranded.
9 (2) The adulteration or misbranding of any controlled
10 substance, other drug, device or cosmetic.
11 (3) The dissemination or publication of any false or
12 materially misleading advertisement.
13 (4) The removal or disposal of a detained or embargoed
14 substance or article, whether or not such substance or article
15 is in fact adulterated or misbranded.
16 (5) The adulteration, mutilation, destruction, obliteration
17 or removal of the whole or any part of the labeling of, or the
18 doing of any other act with respect to a controlled substance,
19 other drug, device or cosmetic, if such act is done while such
20 substance or article is held for sale and results in such
21 substance or article being adulterated or misbranded.
22 (6) Forging, counterfeiting, simulating or falsely
23 representing, or without proper authority using any mark, stamp,
24 tag, label or other identification symbol authorized or required
25 by regulation promulgated under the provisions of this act.
26 (7) Placing or causing to be placed upon any controlled
27 substance, other drug, device or cosmetic, or upon the container
28 of any controlled substance, other drug, device or cosmetic,
29 with intent to defraud, the trademark, trade name or other
30 identifying mark, imprint or symbol of another, or any likeness
19710H0851B2698 - 33 -
1 of any of the foregoing.
2 (8) Selling, dispensing, disposing of or causing to be sold,
3 dispensed or disposed of, or keeping in possession, control or
4 custody, or concealing any controlled substance, other drug,
5 device or cosmetic or any container of any drug, device or
6 cosmetic with knowledge that the trademark, trade name or other
7 identifying mark, imprint or symbol of another, or any likeness
8 of any of the foregoing, has been placed thereon in a manner
9 prohibited by clause (7) hereof.
10 (9) Making, selling, disposing of or causing to be made,
11 sold, or disposed of, or keeping in possession, control or
12 custody, or concealing with intent to defraud, any punch, die,
13 plate, stone or other thing designed to print, imprint or
14 reproduce the trademark, trade name or other identifying mark,
15 imprint or symbol of another or any likeness of any of the
16 foregoing upon any controlled substance, other drug, device or
17 cosmetic or container thereof.
18 (10) The sale at retail of a nonproprietary drug except by a
19 registered pharmacist in a licensed pharmacy or by a
20 practitioner.
21 (11) The operation of a drug manufacturing, distributing or
22 retailing establishment, except by registered pharmacists in a
23 licensed pharmacy, without conforming with such standards
24 respecting sanitation, materials, equipment and supplies as the
25 secretary, after consultation with the board, may establish by
26 regulation for the protection of the public health and safety.
27 (12) The acquisition or obtaining of possession of a
28 controlled substance by misrepresentation, fraud, forgery,
29 deception or subterfuge.
30 (13) The sale, dispensing, distribution, prescription or
19710H0851B2698 - 34 -
1 gift by any practitioner otherwise authorized by law so to do of
2 any controlled substance to any person known to such
3 practitioner to be or whom such practitioner has reason to know
4 is a drug dependent person, unless said drug is prescribed,
5 administered, dispensed or given, for the cure or treatment of
6 some malady other than drug dependency, except that a controlled
7 substance, including but not limited to methadone, may be
8 permitted for the treatment of drug dependency pursuant to
9 regulations of the secretary providing for such use. This clause
10 shall not prohibit any practitioner from prescribing,
11 distributing or dispensing any controlled substance on a short
12 term basis pending confirmed admission of the patient to a
13 hospital or rehabilitation center.
14 (14) The administration, dispensing, delivery, gift or
15 prescription by any practitioner otherwise authorized by law so
16 to do of any controlled substance except after a physical or
17 visual examination of the person or animal for whom said drugs
18 are intended, said examination to be made at the time said
19 prescription order is issued or at the time said drug is
20 administered, dispensed, given away or delivered by said
21 practitioner, or except where the practitioner is satisfied by
22 evidence that the person is not a drug dependent person.
23 (15) The sale at retail or dispensing of any controlled
24 substance listed in Schedules II, III and IV to any person,
25 except to one authorized by law to sell, dispense, prescribe or
26 possess such substances, unless upon the written or oral
27 prescription of a person licensed by law to prescribe such drug
28 and unless compounded or dispensed by a registered pharmacist or
29 pharmacy intern under the immediate personal supervision of a
30 registered pharmacist, or the refilling of a written or oral
19710H0851B2698 - 35 -
1 prescription order for a drug, unless such refilling is
2 authorized by the prescriber either in the original written
3 prescription order or by written confirmation of the original
4 oral prescription order. The provisions of this subsection shall
5 not apply to a practitioner licensed to prescribe or dispense
6 such drugs, who keeps a record of the amount of such drugs
7 purchased and a dispensing record showing the date, name, and
8 quantity of the drug dispensed and the name and address of the
9 patient, as required by this act.
10 (16) Knowingly or intentionally possessing a controlled or
11 counterfeit substance by a person not registered under this act,
12 or a practitioner not registered or licensed by the appropriate
13 State board, unless the substance was obtained directly from, or
14 pursuant to, a valid prescription order or order of a
15 practitioner, or except as otherwise authorized by this act.
16 (17) The wilful dispensing of a controlled substance by a
17 practitioner otherwise authorized by law so to do without
18 affixing to the container in which the drug is sold or dispensed
19 a label bearing the name and address of the practitioner, the
20 date dispensed, the name of the patient and the directions for
21 the use of the drug by the patient.
22 (18) The selling by a pharmacy or distributor of any
23 controlled substance or other drug unless the container bears a
24 label, securely attached thereto, stating the specific name of
25 the drug and the proportion or amount thereof unless otherwise
26 specifically directed in writing by the practitioner.
27 (19) The intentional purchase or knowing receipt in commerce
28 by any person of any controlled substance, other drug or device
29 from any person not authorized by law to sell, distribute,
30 dispense or otherwise deal in such controlled substance, other
19710H0851B2698 - 36 -
1 drug or device.
2 (20) The using by any person to his own advantage or
3 revealing other than to the secretary or officers or employes of
4 the department or to the council or to the board or to courts or
5 a hearing examiner when relevant to proceedings under this act
6 any information acquired under authority of this act concerning
7 any method or process which as a trade secret is entitled to
8 protection. Such information obtained under the authority of
9 this act shall not be admitted in evidence in any proceeding
10 before any court of the Commonwealth except in proceedings under
11 this act.
12 (21) The refusal or failure to make, keep or furnish any
13 record, notification, order form, statement, invoice or
14 information required under this act.
15 (22) The refusal of entry into any premises for any
16 inspection authorized by this act.
17 (23) The unauthorized removing, breaking, injuring, or
18 defacing a seal placed upon embargoed substances or the removal
19 or disposal of substances so placed under seal.
20 (24) The failure by a manufacturer or distributor to
21 register or obtain a license as required by this act.
22 (25) The manufacture of a controlled substance by a
23 registrant who knows or who has reason to know, the
24 manufacturing is not authorized by his registration, or who
25 knowingly distributes a controlled substance not authorized by
26 his registration to another registrant or other authorized
27 person.
28 (26) The knowing distribution by a registrant of a
29 controlled substance classified in Schedules I or II, except
30 pursuant to an order form as required by this act.
19710H0851B2698 - 37 -
1 (27) The use in the course of the manufacture or
2 distribution of a controlled substance of a registration number
3 which is fictitious, revoked, suspended, or issued to another
4 person.
5 (28) The furnishing of false or fraudulent material
6 information in, or omission of any material information from any
7 application, report, or other document required to be kept or
8 filed under this act, or any record required to be kept by this
9 act.
10 (29) The intentional making, distributing, or possessing of
11 any punch, die, plate, stone, or other thing designed to print,
12 imprint, or reproduce the trademark, trade name, or other
13 identifying mark, imprint, or symbol of another or any likeness
14 of any of the foregoing upon any drug or container or labeling
15 thereof so as to render the drug a counterfeit substance.
16 (30) Except as authorized by this act, the manufacture,
17 delivery, or possession with intent to manufacture or deliver, a
18 controlled substance by a person not registered under this act,
19 or a practitioner not registered or licensed by the appropriate
20 State board, or knowingly creating, delivering or possessing
21 with intent to deliver, a counterfeit controlled substance.
22 (31) Notwithstanding other subsections of this section, (i)
23 the possession of a small amount of marihuana only for personal
24 use; (ii) the possession of a small amount of marihuana with the
25 intent to distribute it but not to sell it; or (iii) the
26 distribution of a small amount of marihuana but not for sale.
27 For purposes of this subsection, thirty (30) grams of
28 marihuana or eight (8) grams of hashish shall be considered a
29 small amount of marihuana.
30 (b) Any person who violates any of the provisions of clauses
19710H0851B2698 - 38 -
1 (1) through (20) of subsection (a) shall be guilty of a
2 misdemeanor, and except for clauses (4), (6), (7), (8), (9) and
3 (19) shall, on conviction thereof, be sentenced to imprisonment
4 not exceeding one year or to pay a fine not exceeding five
5 thousand dollars ($5,000), or both and for clauses (4), (6),
6 (7), (8), (9) and (19) shall, on conviction thereof, be
7 sentenced to imprisonment not exceeding three years or to pay a
8 fine not exceeding five thousand dollars ($5,000), or both; but,
9 if the violation is committed after a prior conviction of such
10 person for a violation of this act under this section has become
11 final, such person shall be sentenced to imprisonment not
12 exceeding three years or to pay a fine not exceeding twenty-five
13 thousand dollars ($25,000), or both.
14 (c) Any person who violates the provisions of clauses (21),
15 (22) and (24) of subsection (a) shall be guilty of a
16 misdemeanor, and shall, on conviction thereof, be punished only
17 as follows:
18 (1) Upon conviction of the first such offense, he shall be
19 sentenced to imprisonment not exceeding six months, or to pay a
20 fine not exceeding ten thousand dollars ($10,000), or both.
21 (2) Upon conviction of the second and subsequent offense, he
22 shall be sentenced to imprisonment not exceeding two years, or
23 to pay a fine not exceeding twenty-five thousand dollars
24 ($25,000), or both.
25 (d) Any person who knowingly or intentionally violates
26 clause (23) of subsection (a) is guilty of a misdemeanor and
27 upon conviction thereof shall be sentenced to imprisonment not
28 exceeding three years, or to pay a fine not exceeding fifteen
29 thousand dollars ($15,000), or both.
30 (e) Any person who violates clauses (25) through (29) of
19710H0851B2698 - 39 -
1 subsection (a) is guilty of a misdemeanor and upon conviction
2 shall be sentenced to imprisonment not exceeding three years, or
3 to pay a fine not exceeding twenty-five thousand dollars
4 ($25,000), or both.
5 (f) Any person who violates clause (30) of subsection (a)
6 with respect to:
7 (1) A controlled substance or counterfeit substance
8 classified in Schedule I or II which is a narcotic drug, is
9 guilty of a felony and upon conviction thereof shall be
10 sentenced to imprisonment not exceeding fifteen years, or to pay
11 a fine not exceeding two hundred fifty thousand dollars
12 ($250,000), or both or such larger amount as is sufficient to
13 exhaust the assets utilized in and the profits obtained from the
14 illegal activity.
15 (2) Any other controlled substance or counterfeit substance
16 classified in Schedule I, II, or III, is guilty of a felony and
17 upon conviction thereof shall be sentenced to imprisonment not
18 exceeding five years, or to pay a fine not exceeding fifteen
19 thousand dollars ($15,000), or both.
20 (3) A controlled substance or counterfeit substance
21 classified in Schedule IV, is guilty of a felony and upon
22 conviction thereof shall be sentenced to imprisonment not
23 exceeding three years, or to pay a fine not exceeding ten
24 thousand dollars ($10,000), or both.
25 (4) A controlled substance or counterfeit substance
26 classified in Schedule V, is guilty of a misdemeanor and upon
27 conviction thereof shall be sentenced to imprisonment not
28 exceeding one year, or to pay a fine not exceeding five thousand
29 dollars ($5,000), or both.
30 (g) Any person who violates clause (31) of subsection (a) is
19710H0851B2698 - 40 -
1 guilty of a misdemeanor and upon conviction thereof shall be
2 sentenced to imprisonment not exceeding thirty days, or to pay a
3 fine not exceeding five hundred dollars ($500), or both.
4 (h) Any penalty imposed for violation of this act shall be
5 in addition to, and not in lieu of, any civil or administrative
6 penalty or sanction authorized by law.
7 Section 14. Distribution to Persons Under Age Eighteen.--Any
8 person who is at least twenty-one years of age who violates this
9 act by distributing a controlled substance listed in Schedules I
10 through V to a person under eighteen years of age who is at
11 least five years his junior is punishable by a term of
12 imprisonment up to twice that otherwise authorized by subsection
13 (f) of section 13 of this act, in addition to any fine
14 authorized by this act.
15 Section 15. Second or Subsequent Offense.--(a) Any person
16 convicted of a second or subsequent offense under clause (30) of
17 subsection (a) of section 13 of this act or of a similar offense
18 under any statute of the United States or of any state prior to
19 the commission of the second offense may be imprisoned for a
20 term up to twice the term otherwise authorized, fined an amount
21 up to twice that otherwise authorized, or both.
22 (b) For purposes of this section, an offense is considered a
23 second or subsequent offense, if, prior to the commission of the
24 second offense, the offender has at any time been convicted
25 under this act or under any statute of the United States or of
26 any state relating to controlled substances.
27 Section 16. Enforcement Provisions.--The following
28 guidelines shall be applicable in the enforcement of any
29 penalties imposed by this act:
30 (1) No publisher, radio broadcast licensee, or agency or
19710H0851B2698 - 41 -
1 medium for the dissemination of an advertisement, except the
2 manufacturer, distributor or seller of the article to which a
3 false advertisement relates, shall be liable under section 12 of
4 this act by reason of the dissemination by him of such false
5 advertisement unless he has refused on the request of the
6 secretary to furnish the secretary with the name and post office
7 address of the manufacturer, distributor, seller or advertising
8 agency who causes him to disseminate such advertisement or
9 unless he publishes such advertisement knowing or having good
10 cause to know that it is false or otherwise in violation of the
11 law.
12 (2) For purposes of this section, any conviction under any
13 Federal or State law relating to any controlled substance or
14 other drug, other than a juvenile violation, shall constitute a
15 prior offense if it related to the type of conduct against which
16 a subsequent offense is directed.
17 (3) Any penalty relating to license or registration
18 suspension or revocation shall be executed by the appropriate
19 licensing or registration agency upon receipt of a court order
20 setting forth the penalty.
21 (4) The probation or parole or other conditional release or
22 discharge of any person convicted of an offense under this act
23 or of any other offense may be conditioned on the person's
24 agreement to periodic urinalyses or other reasonable means of
25 detection. A relapse into drug abuse one or more times or the
26 failure to conform to a set schedule for rehabilitation, or
27 both, in themselves shall not require that his status be revoked
28 or treatment denied.
29 Section 17. Probation Without Verdict.--A person may be
30 entitled to probation without verdict under the following
19710H0851B2698 - 42 -
1 circumstances:
2 (1) A person who has not previously been convicted of an
3 offense under this act or under a similar act of the United
4 States, or any other state, is eligible for probation without
5 verdict if he pleads nolo contendere or guilty to, or is found
6 guilty of, any nonviolent offense under this act. The court may,
7 without entering a judgment, and with the consent of such
8 person, defer further proceedings and place him on probation for
9 a specific time period not to exceed the maximum for the offense
10 upon such reasonable terms and conditions as it may require.
11 Probation without verdict shall not be available to any
12 person who is charged with violating clause (30) of subsection
13 (a) of section 13 of this act and who is not himself a drug
14 abuser.
15 (2) Upon violation of a term or condition of probation, the
16 court may enter a judgment and proceed as in any criminal case,
17 or may continue the probation without verdict.
18 (3) Upon fulfillment of the terms and conditions of
19 probation, the court shall discharge such person and dismiss the
20 proceedings against him. Discharge and dismissal shall be
21 without adjudication of guilt and shall not constitute a
22 conviction for any purpose whatever, including the penalties
23 imposed for second or subsequent convictions: Provided, That
24 probation without verdict shall be available to any person only
25 once: And further provided, That notwithstanding any other
26 provision of this act, the prosecuting attorney or the court and
27 the council shall keep a list of those persons placed on
28 probation without verdict, which list may only be used to
29 determine the eligibility of persons for probation without
30 verdict and the names on such lists may be used for no other
19710H0851B2698 - 43 -
1 purpose whatsoever.
2 Section 18. Disposition in Lieu of Trial.--(a) If a person
3 charged with a nonviolent crime claims to be drug dependent or a
4 drug abuser and prior to trial he requests appropriate
5 treatment, including but not limited to, admission or commitment
6 under the Mental Health and Mental Retardation Act of 1966 in
7 lieu of criminal prosecution, a physician experienced or trained
8 in the field of drug dependency or drug abuse shall be appointed
9 by the court to examine, if necessary, and to review the
10 accused's record and advise the government attorney, the accused
11 and the court in writing setting forth that for the treatment
12 and rehabilitation of the accused it would be preferable for the
13 criminal charges to be held in abeyance or withdrawn in order to
14 institute treatment for drug dependence or for the criminal
15 charges to be prosecuted. The government attorney shall exercise
16 his discretion whether or not to accept the physician's
17 recommendation.
18 (b) In the event that he does not accept the physician's
19 recommendation he shall state in writing and furnish the
20 defendant a copy of his decision and the reasons therefor.
21 (c) If the government attorney accepts the physician's
22 advice to hold in abeyance, he shall arrange for a hearing
23 before the appropriate court to hold in abeyance the criminal
24 prosecution. The court, upon its approval, shall proceed to make
25 appropriate arrangements for treatment.
26 (d) The government attorney, upon his own application, may
27 institute proceedings for appropriate treatment, including but
28 not limited to, commitment pursuant to the Mental Health and
29 Mental Retardation Act of 1966.
30 (e) A criminal charge may be held in abeyance pursuant to
19710H0851B2698 - 44 -
1 this section for no longer than the lesser of either (i) the
2 appropriate statute of limitations or (ii) the maximum term that
3 could be imposed for the offense charged. At the expiration of
4 such period, the criminal charge shall be automatically
5 dismissed. A criminal charge may not be prosecuted except by
6 order of court so long as the medical director of the treatment
7 facility certifies that the accused is cooperating in a
8 prescribed treatment program and is benefiting from treatment.
9 (f) If, after conviction, the defendant requests probation
10 with treatment or civil commitment for treatment in lieu of
11 criminal punishment the court may appoint a qualified physician
12 to advise the court in writing whether it would be preferable
13 for the purposes of treatment and rehabilitation for him to
14 receive a suspended sentence and probation on the condition that
15 he undergo education and treatment for drug abuse and drug
16 dependency, or to be committed pursuant to the Mental Health and
17 Mental Retardation Act of 1966 for treatment in lieu of criminal
18 punishment, or to receive criminal incarceration. A copy of the
19 physician's report shall be furnished the court, the defendant
20 and the government attorney. The court shall exercise its
21 discretion whether to accept the physician's advice.
22 (g) Disposition in lieu of trial as provided in this section
23 shall be available to any person only once.
24 Section 19. Expunging Criminal Records.--(a) Any records of
25 arrest or prosecution or both for a criminal offense under this
26 act, except for persons indicted for violations of clause (30)
27 of subsection (a) of section 13, or under the provisions
28 previously governing controlled substances in the Commonwealth
29 of Pennsylvania or any political subdivision thereof shall be
30 promptly expunged from the official and unofficial arrest and
19710H0851B2698 - 45 -
1 other criminal records, files and other documents pertaining to
2 the particular arrest or prosecution or both when the charges
3 are withdrawn or dismissed or the person is acquitted of the
4 charges: Provided, That such expungment shall be available as a
5 matter of right to any person only once. Within five days after
6 such withdrawal, dismissal or acquittal the court, in writing,
7 shall order the appropriate keepers of criminal records (i) to
8 expunge and destroy the official and unofficial arrest and other
9 criminal records, files and other documents pertaining to the
10 arrest or prosecution or both, to request in so far as they are
11 able the return of such records as they have made available to
12 Federal and other State agencies, and to destroy such records on
13 receipt thereof; and (ii) to file with the court within thirty
14 days an affidavit that such records have been expunged and
15 destroyed, together with the court's expunction order and to
16 retain no copies thereof. Upon receipt of such affidavit, the
17 court shall seal the same together with the original and all
18 copies of its expunction order and shall not permit any person
19 or agency to examine such sealed documents.
20 The court shall file with the council a list of those persons
21 whose record was expunged. The council shall maintain a
22 confidential list which list may be used only for the purpose of
23 determining the eligibility of persons for the expunction
24 provisions under this section and to be made available to any
25 court upon request.
26 (b) Any expunged record of arrest or prosecution shall not
27 hereafter be regarded as an arrest or prosecution for the
28 purpose of any statute or regulation or license or questionnaire
29 or any civil or criminal proceeding or any other public or
30 private purpose. No person shall be permitted to learn of an
19710H0851B2698 - 46 -
1 expunged arrest or prosecution, or of the expunction, either
2 directly or indirectly. Any person, except the individual
3 arrested or prosecuted, who divulges such information in
4 violation of this subsection shall be guilty of a summary
5 offense and shall, upon conviction thereof, be punished by
6 imprisonment not exceeding thirty (30) days or a fine not
7 exceeding five hundred dollars ($500), or both.
8 (c) Nothing contained in this section shall prohibit a
9 person acting pursuant to prior practice from petitioning an
10 appropriate court for an expunction order.
11 Section 20. Offenses by a Corporation, Copartnership or
12 Association.--If any violation of the provisions of this act is
13 by a corporation, copartnership or association, the officers and
14 directors of such corporation or the members of such
15 copartnership or association, the agents and employes with prior
16 guilty knowledge of the fact, shall be deemed guilty of a
17 violation of the provisions of this act to the same extent as
18 though said violation were committed by them personally.
19 Section 21. Burden of Proving Exemptions.--In any
20 prosecution under this act, it shall not be necessary to negate
21 any of the exemptions or exceptions of this act in any
22 complaint, information or trial. The burden of proof of such
23 exemption or exception shall be upon the person claiming it.
24 Section 22. Judicial Review.--Any person aggrieved by a
25 final administrative decision may obtain review of the decision
26 pursuant to the provisions of the Administrative Agency Law.
27 Section 23. Revocation of Licenses of Practitioners.--(a)
28 Any license or registration heretofore issued to any
29 practitioner may either be revoked or suspended by the proper
30 officers or boards having power to issue licenses or
19710H0851B2698 - 47 -
1 registration to any of the foregoing, upon proof that the
2 licensee or registrant is a drug dependent person on the use of
3 any controlled substance after giving such licensee or
4 registrant reasonable notice and opportunity to be heard.
5 (b) The appropriate licensing boards in the Department of
6 State are hereby authorized to revoke or suspend the
7 registration or license of any practitioner when such person has
8 pleaded guilty or nolo contendere or has been convicted of a
9 felony under this act or any similar State or Federal law.
10 Before any such revocation or suspension, the licensee or
11 registrant shall be given a hearing before the appropriate
12 board. At such hearing the accused may be represented by counsel
13 and shall be entitled to compulsory attendance of witnesses.
14 Section 24. Administrative Inspections and Warrants.--(a) As
15 used in this section, the term "controlled premises" means:
16 (1) Places where original or other records or documents
17 required under this act are kept or required to be kept; and
18 (2) Places, including factories, warehouses, or other
19 establishments, and conveyances, where persons registered under
20 section 6 (or exempted from registration under section 6) may
21 lawfully hold, manufacture, or distribute, dispense, administer
22 or otherwise dispose of controlled substances.
23 (b) (1) For the purpose of inspecting, copying, and
24 verifying the correctness of records, reports, or other
25 documents required to be kept or made under this act and
26 otherwise facilitating the carrying out of his functions under
27 this act, the secretary is authorized, in accordance with this
28 section, to enter controlled premises and to conduct
29 administrative inspections thereof, and of the things specified
30 in this section, relevant to those functions.
19710H0851B2698 - 48 -
1 (2) Such entries and inspections shall be carried out
2 through officers or employes (hereinafter referred to as
3 "officers") designated by the secretary. Any such officer upon
4 stating his purpose and presenting to the owner, operator, or
5 officer in charge of such premises (i) appropriate credentials
6 and (ii) a written notice of his inspection authority (which
7 notice in the case of an inspection requiring, or in fact
8 supported by, an administrative inspection warrant shall consist
9 of such warrant), shall have the right to enter such premises
10 and conduct such inspection at reasonable times.
11 (3) Except as may otherwise be indicated in an applicable
12 inspection warrant, the officer shall have the right: (i) to
13 inspect and copy records, reports, and other documents required
14 to be kept or made under this act; (ii) to inspect, within
15 reasonable limits and in a reasonable manner, controlled
16 premises and all pertinent equipment, finished and unfinished
17 drugs and other substances or materials, containers, and
18 labeling found therein, and, except as provided in this
19 subsection, all other things therein (including records, files,
20 papers, processes, controls, and facilities) appropriate for
21 verification of the records, reports, and documents referred to
22 in subclause (i) or otherwise bearing on the provisions of this
23 act; and (iii) to inventory any stock of any controlled
24 substance therein and obtain samples of any such substance or
25 article.
26 (4) Except when the owner, operator, or officer in charge of
27 the controlled premises so consents in writing, no inspection
28 authorized by this section shall extend to: (i) financial data;
29 (ii) sales data other than shipment data; (iii) pricing data; or
30 (iv) research data.
19710H0851B2698 - 49 -
1 (c) A warrant under this section shall not be required for
2 the inspection of books and records pursuant to an
3 administrative subpoena issued in accordance with any provisions
4 of any Act of Assembly nor for entries and administrative
5 inspections (including seizures of property):
6 (1) With the consent of the owner, operator, or officer in
7 charge of the controlled premises;
8 (2) In situations presenting imminent danger to health or
9 safety;
10 (3) In situations involving inspection of conveyances where
11 there is reasonable cause to believe that the mobility of the
12 conveyance makes it impracticable to obtain a warrant;
13 (4) In any other exceptional or emergency circumstance where
14 time or opportunity to apply for a warrant is lacking; or
15 (5) In any other situations where a warrant is not
16 constitutionally required.
17 (d) Issuance and execution of administrative inspection
18 warrants shall be as follows:
19 (1) Any judge of a court, may, within his territorial
20 jurisdiction, and upon proper oath or affirmation showing
21 probable cause, issue warrants for the purpose of conducting
22 administrative inspections authorized by this act or regulations
23 thereunder, and seizures of property appropriate to such
24 inspections. For the purposes of this section, the term
25 "probable cause" exists upon showing a valid public interest in
26 the effective enforcement of this act or regulations thereunder
27 sufficient to justify administrative inspections of the area,
28 premises, building, or conveyance, or contents thereof, in the
29 circumstances specified in the application for the warrant.
30 (2) A warrant shall issue only upon an affidavit of a
19710H0851B2698 - 50 -
1 designated officer or employe having knowledge of the facts
2 alleged, sworn to before the judge and establishing the grounds
3 for issuing the warrant. If the judge is satisfied that grounds
4 for the application exist or that there is probable cause to
5 believe they exist, he shall issue a warrant identifying the
6 area, premises, building, or conveyance to be inspected, the
7 purpose of such inspection, and, where appropriate, the type of
8 property to be inspected, if any. The warrant shall identify the
9 items or types of property to be seized, if any. The warrant
10 shall be directed to a person authorized under subsection (b)
11 (2) to execute it. The warrant shall state the grounds for its
12 issuance and the name of the person or persons whose affidavit
13 has been taken in support thereof. It shall command the person
14 to whom it is directed to inspect the area, premises, building,
15 or conveyance identified for the purpose specified, and, where
16 appropriate, shall direct the seizure of the property specified.
17 The warrant shall direct that it be served during normal
18 business hours. It shall designate the judge to whom it shall be
19 returned.
20 (3) A warrant issued pursuant to this section must be
21 executed and returned within ten days of its date unless, upon a
22 showing by the secretary of a need therefor, the judge allows
23 additional time in the warrant. If property is seized pursuant
24 to a warrant, the person executing the warrant shall give to the
25 person from whom or from whose premises the property was taken a
26 copy of the warrant and a receipt for the property taken or
27 shall leave the copy and receipt at the place from which the
28 property was taken. The return of the warrant shall be made
29 promptly and shall be accompanied by a written inventory of any
30 property taken. The inventory shall be made in the presence of
19710H0851B2698 - 51 -
1 the person executing the warrant and of the person from whose
2 possession or premises the property was taken, if they are
3 present, or in the presence of at least one credible person
4 other than the person making such inventory, and shall be
5 verified by the person executing the warrant. A copy of the
6 inventory shall be delivered to the person from whom or from
7 whose premises the property was taken and to the applicant for
8 the warrant.
9 (4) The judge who has issued a warrant under this section
10 shall attach to the warrant a copy of the return and all papers
11 returnable filed in connection therewith and shall file them
12 with the clerk of the court for the judicial district in which
13 the inspection was made.
14 Section 25. Injunctive Relief.--In addition to the remedies
15 provided herein, the secretary is hereby authorized to apply to
16 the court of common pleas in the county in which such violation
17 occurs or to the Commonwealth Court for, and such court shall
18 have jurisdiction to grant, a temporary or permanent injunction
19 restraining any person from continued violation of any provision
20 of this act irrespective of the existence of an adequate remedy
21 at law.
22 Section 26. Cooperation With Other Authorities.--The
23 agencies charged with the enforcement of this act shall actively
24 cooperate and coordinate with the agencies charged with the
25 enforcement of all Federal and State laws relating to the
26 regulation of the distribution of controlled substances, other
27 drugs, devices or cosmetics.
28 Section 27. Embargo.--(a) Whenever a duly authorized officer
29 of the secretary finds or has probable cause to believe that any
30 controlled substance, other drug, device or cosmetic is
19710H0851B2698 - 52 -
1 adulterated or misbranded or contraband, the same shall be
2 deemed subject to embargo and he shall affix to such substance
3 or article a tag or other appropriate marking, approved by the
4 secretary, giving notice that such substance or article is or is
5 suspected of being adulterated, misbranded or contraband and
6 warning all persons not to remove or dispose of such substance
7 or article until permission so to do has been granted by such
8 officer, or until it shall have determined by proper authority
9 that such substance or article is not adulterated, misbranded or
10 contraband. At the time such notice is offered, the officer
11 shall provide the person in charge of such substance or article,
12 if any, or the owner, if he is known, a statement in writing,
13 setting forth both the basis for the embargo and supporting
14 facts.
15 (b) When a substance or article is detained or embargoed
16 under subsection (a), the secretary shall serve within three
17 days from the date of such embargo a citation upon the claimant
18 thereof or owner, if he is known, setting forth both the basis
19 for the embargo and supporting facts and fixing a date for a
20 hearing not later than ten days from the date of service of said
21 citation at which a hearing examiner, appointed under the
22 authority of section 30, will receive evidence pertaining to the
23 alleged offense. Unless postponed by mutual consent, failure to
24 serve a citation or commence hearings within the time herein
25 specified shall operate to void such embargo.
26 (c) If, after hearing, the examiner is satisfied from the
27 evidence presented that a detained or embargoed substance or
28 article is adulterated, misbranded or contraband, he shall,
29 within five days of the conclusion of the hearing, order such
30 substance or article destroyed at the expense of the claimant
19710H0851B2698 - 53 -
1 thereof under supervision of an agent of the secretary:
2 Provided, That when the embargo is based on an adulteration or
3 misbranding which can be corrected by proper labeling or
4 processing of the substance or article, the examiner, after
5 entry of the order and after such costs, fees and expenses have
6 been paid and a good and sufficient bond conditioned that such
7 substance or article shall be so labeled or processed has been
8 executed, may by order direct that such substance or article be
9 released to the claimant thereof for such labeling or processing
10 under the supervision of an officer of the secretary. The
11 expense of such supervision, if any, shall be paid by the
12 claimant. Such substance or article shall be released to the
13 claimant when it is no longer in violation of this act and the
14 expenses of such supervision have been paid.
15 (d) If no claimant shall appear to defend such proceedings,
16 the hearing examiner may order the embargoed substances or
17 articles destroyed or distributed to a nonprofit institution.
18 Section 28. Forfeiture.--(a) The following shall be subject
19 to forfeiture to the Commonwealth and no property right shall
20 exist in them:
21 (1) All controlled substances or other drugs which have been
22 manufactured, distributed, dispensed, or acquired in violation
23 of this act.
24 (2) All raw materials, products, and equipment of any kind
25 which are used, or intended for use in manufacturing,
26 compounding, processing, delivering, importing, or exporting any
27 controlled substance or other drug in violation of this act.
28 (3) All property which is used, or intended for use, as a
29 container for property described in clause (1) or (2) of this
30 subsection.
19710H0851B2698 - 54 -
1 (4) All conveyances, including aircraft, vehicles, or
2 vessels, which are used or are intended for use, to transport,
3 or in any manner to facilitate the transportation, sale,
4 receipt, possession, or concealment of property described in
5 clause (1) or (2) except that:
6 (i) no conveyance used by any person as a common carrier in
7 the transaction of business as a common carrier shall be
8 forfeited under the provisions of this section unless it shall
9 appear that the owner or other person in charge of such
10 conveyance was a consenting party or privy to a violation of
11 this title;
12 (ii) no conveyance shall be forfeited under the provisions
13 of this section by reason of any act or omission established by
14 the owner thereof to have been committed or omitted without his
15 knowledge or consent;
16 (iii) no bona fide security interest retained or acquired
17 under the Uniform Commercial Code by any merchant dealing in new
18 or used aircraft, vehicles or vessels, or retained or acquired
19 by any licensed or regulated finance company, bank, lending
20 institution, or by any other business regularly engaged in the
21 financing of, or lending on the security of, such aircraft,
22 vehicles or vessels, shall be subject to forfeiture or
23 impairment; and
24 (iv) no conveyance shall be forfeited under this section for
25 violation of clauses (16) and (31) of subsection (a) of section
26 13.
27 (5) All books, records, and research, including formulas,
28 microfilm, tapes and data which are used, or intended for use,
29 in violation of this act.
30 (b) Property subject to forfeiture under this act may be
19710H0851B2698 - 55 -
1 seized by the law enforcement authority upon process issued by
2 any court of common pleas having jurisdiction over the property.
3 Seizure without process may be made if:
4 (1) The seizure is incident to an arrest or a search under a
5 search warrant or inspection under an administrative inspection
6 warrant;
7 (2) The property subject to seizure has been the subject of
8 a prior judgment in favor of the Commonwealth in a criminal
9 injunction or forfeiture proceeding under this act;
10 (3) There is probable cause to believe that the property is
11 dangerous to health or safety; or
12 (4) There is probable cause to believe that the property has
13 been used or is intended to be used in violation of this act.
14 (c) In the event seizure without process occurs, as provided
15 herein, proceedings for the issuance thereof shall be instituted
16 forthwith.
17 (d) Property taken or detained under this section shall not
18 be subject to replevin, but is deemed to be in the custody of
19 the law enforcement authority subject only to the orders and
20 decrees of the court of common pleas having jurisdiction over
21 the forfeiture proceedings and of the secretary. When property
22 is seized under this act, the law enforcement authority shall:
23 (1) Place the property under seal; and either
24 (2) Remove the property to a place designated by it; or
25 (3) Require that the department take custody of the property
26 and remove it to an appropriate location for disposition in
27 accordance with law.
28 (e) Whenever property is forfeited under this act, the
29 property shall be transferred to the custody of the department
30 and the secretary may:
19710H0851B2698 - 56 -
1 (1) Retain the property for official use;
2 (2) Sell any forfeited property which is not required to be
3 destroyed by law and which is not harmful to the public, but the
4 proceeds from any such sale shall be used to pay all proper
5 expenses of the proceedings for forfeiture and sale including
6 expenses of seizure, maintenance of custody, advertising and
7 court costs.
8 Section 29. Procedure With Respect to Seized Property
9 Subject to Liens and Rights of Lienholders.--(a) The person who
10 seized said property shall notify the registered owner and
11 lienholder, where possible, and shall publish notice in a
12 newspaper of general circulation in the county or the city,
13 where seized, of any vehicle, vessel or aircraft confiscated
14 informing interested persons of the seizure and right to file a
15 claim protesting the confiscation of said vehicle, vessel or
16 aircraft.
17 (b) Any lawful lienholder, or other person showing a legal
18 right, title or interest in a vehicle, vessel or aircraft,
19 confiscated pursuant to this subtitle may, within thirty days of
20 publication of notice file a claim protesting such seizure with
21 the court or with the person having jurisdiction thereof. When
22 such a claim is filed, the court of common pleas of the county
23 wherein the property was confiscated, shall proceed in rem to
24 hear and determine the question of forfeiture.
25 (c) If the court determines any property is subject to
26 forfeiture it shall also determine whether any lawful lienholder
27 who has filed a timely claim and protest had knowledge of such
28 intended unlawful use. If the court shall find such knowledge
29 then the lienholder's right, title and interest to the property
30 shall likewise be deemed forfeited. If the court does not find
19710H0851B2698 - 57 -
1 such knowledge and the property is otherwise subject to
2 forfeiture, it shall be forfeited and the person having custody
3 of such property shall either pay the outstanding indebtedness
4 secured by such lawful lien and keep the property or deliver the
5 property to the said lienholder.
6 Section 30. Hearing Examiners.--(a) The secretary shall
7 appoint, with the approval of the Governor, such hearing
8 examiners as shall be necessary to conduct hearings as provided
9 in section 27.
10 (b) Hearing examiners appointed under this act shall have
11 the power to issue subpoenas requiring the attendance and
12 testimony of, or the production of, pertinent books and papers
13 by persons whom they believe to have information relevant to any
14 matter pending before him. Such examiner shall also have the
15 power to administer oaths.
16 (c) Any person who refuses to obey a subpoena issued
17 hereunder or to be sworn or affirmed or to testify, or who is
18 guilty of any contempt after summons to appear, may be punished
19 as for contempt of court. For this purpose, an application may
20 be made by the examiner to the court of common pleas within the
21 territorial jurisdiction of which the offense was committed for
22 which purpose such court is hereby given jurisdiction.
23 (d) In any action or proceeding before him, the hearing
24 examiner may assess all costs incurred in connection with the
25 prosecution of such proceeding, including investigative and
26 laboratory costs incurred by the Commonwealth, against
27 respondent in such proceeding; such costs to be in addition to
28 any other penalty imposed and to be retained by the Department
29 of Health and applied to cost to the department administering
30 this act.
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1 (e) Hearings shall be conducted under the provisions of the
2 Administrative Agency Law, as amended, and subject to such other
3 rules and regulations not inconsistent therewith as the
4 secretary may provide and any person aggrieved by any action of
5 the hearing examiner may appeal in accordance with the
6 provisions of the Administrative Agency Law, as amended.
7 Section 31. Board Creation.--(a) There is hereby created
8 within the Department of Health a departmental administrative
9 board to be known as the "Pennsylvania Drug, Device and Cosmetic
10 Board."
11 (b) The board shall consist of the Secretary of Health, his
12 successors in office, and ten additional members whom the
13 Governor shall appoint, by and with the advice and consent of
14 two-thirds of all the members of the Senate. Of the members: one
15 shall be a physician, one a dentist, one a veterinarian, one a
16 psychologist or psychiatrist and one a pharmacist, each of whom
17 shall be duly licensed in their respective professions by the
18 Commonwealth; one shall be a biochemist and one shall be a
19 pharmacologist, each of whom shall have earned an advanced
20 degree in that field from an institution of higher learning and
21 shall have been engaged as such for three years in this State;
22 one shall be a manufacturer registered to manufacture drugs or
23 an employe thereof; and the two remaining persons shall be
24 members of the general public not engaged in any of the
25 aforementioned but one of whom shall be well informed on the
26 problems caused by the abuse and misuse of drugs or other
27 chemicals. Two members initially shall serve for terms of one,
28 two, three and four years, respectively, the particular term of
29 each to be designated by the Governor at the time of
30 appointment. Any additional member, the appointment of whom is
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1 authorized by amending act, shall serve for a term of four
2 years. The terms of all their successors shall be four years
3 each, except that any person appointed to fill a vacancy shall
4 serve only for the unexpired term. Every member's term shall
5 extend until his successor is appointed and qualified. Any
6 appointed member of the board shall be eligible for
7 reappointment. Each member, who is not otherwise an officer or
8 employe of the Commonwealth, when actually engaged in official
9 meetings or otherwise in the performances of his official duties
10 as directed by the chairman, shall receive reimbursement for
11 expenses incurred and per diem compensation at a rate to be set
12 by the Executive Board.
13 (c) The Secretary of Health, or his designate, shall serve
14 as chairman of the board. A majority of the members shall
15 constitute a quorum for the purpose of organizing the board,
16 conducting its business, and exercising all of its powers. A
17 vote of the majority of the members present shall be sufficient
18 for all actions of the board unless the bylaws require a greater
19 number.
20 (d) The board shall have the power to prescribe, amend and
21 repeal bylaws, rules and regulations governing the manner in
22 which the business of the body is conducted and the manner in
23 which the powers granted to it are exercised. The board may
24 delegate supervision of the administration of board activities
25 to an administrative secretary and such other employes as the
26 Secretary of Health shall appoint.
27 (e) The board shall have the power to do all things
28 necessary or convenient to carry out the powers granted to it by
29 this act.
30 (f) The board may, for the authentication of its records,
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1 process and proceedings, adopt, keep and use a common seal of
2 which seal judicial notice shall be taken in all courts of this
3 Commonwealth and any process, writ, notice or other document,
4 which the board may be authorized by law to issue, shall be
5 deemed sufficient if signed by the chairman or secretary of the
6 board and authenticated by such seal. All acts, proceedings,
7 orders, papers, findings, minutes and records of the board, and
8 all reports and documents filed with the board, may be proved in
9 any court of this Commonwealth by a copy thereof certified to by
10 the chairman or secretary of the board with the seal of the
11 board attached.
12 (g) In order to enable the board to carry out the provisions
13 of this act, including its power to advise the secretary on
14 various matters, it shall have the power to issue subpoenas,
15 requiring the attendance and testimony of, or the production of,
16 pertinent books and papers by persons whom the board believes to
17 have information, books or papers of importance to it in
18 carrying out the purposes and intent of this act. Each member of
19 the board and such officers, employes or others employed in the
20 work of the board designated by the chairman of the board also
21 shall have the power to administer oaths and affirmations, to
22 question witnesses thereunder, and to examine such books and
23 papers. The board may issue commissions, letters rogatory, or
24 other appropriate processes outside the Commonwealth.
25 (h) Any person who refuses to obey a subpoena issued
26 hereunder, or to be sworn or affirmed, or to testify, or who is
27 guilty of any contempt after summons to appear, may be punished
28 as for contempt of court. For this purpose an application may be
29 made by the board to the court of common pleas within the
30 territorial jurisdiction of which the offense was committed, for
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1 which purpose, such court is hereby given jurisdiction.
2 Section 32. Persons Authorized to Prescribe Drugs to Remain
3 as Heretofore.--No provision of this act or any rule or
4 regulation promulgated pursuant to this act shall authorize or
5 be construed as authorizing any person to prescribe drugs who is
6 not specifically so authorized under existing law.
7 Section 33. Conformity With Federal Law.--No controlled
8 substance, other drug, device or cosmetic shall be deemed to be
9 adulterated or misbranded under this act if it complies with the
10 applicable Federal act and/or regulations and interpretations
11 issued pursuant thereto, unless the secretary, after
12 consultation with and upon the recommendation of the board,
13 shall have previously promulgated a regulation stating that the
14 applicable provision of the Federal act and/or regulations and
15 interpretations thereof would not be followed.
16 Section 34. Administration of Act.--(a) Except as may be
17 otherwise provided by law, the provisions of this act shall be
18 administered by the department. The secretary is authorized to
19 employ personnel and to fix their compensation subject to the
20 act of April 9, 1929 (P.L.177), known as "The Administrative
21 Code of 1929."
22 (b) The secretary is authorized and directed to establish a
23 Bureau of Drug Control within the department and to employ
24 therein sufficient personnel to perform the duties imposed upon
25 the department by this act.
26 (c) The secretary may designate specific officers and
27 employes of the Bureau of Drug Control as law enforcement
28 personnel and authorize such personnel to:
29 (1) Carry firearms in the performance of his official
30 duties;
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1 (2) Execute and serve search warrants, arrest warrants,
2 administrative inspection warrants, subpoenas, and summonses
3 issued under the authority of the Commonwealth;
4 (3) Make arrests without warrant for any offense under this
5 act committed in his presence, or if he has probable cause to
6 believe that the person to be arrested has committed or is
7 committing a violation of this act which may constitute a
8 felony;
9 (4) Make seizures of property pursuant to this act; or
10 (5) Perform other law enforcement duties as the secretary
11 designates.
12 (d) Nothing contained herein shall be deemed to limit the
13 authority of the Bureau of Drug Control, the Pennsylvania State
14 Police, the Department of Justice or any other law enforcement
15 agency in dealing with law enforcement matters with respect to
16 persons engaged in the unlawful importation, manufacture,
17 distribution, sale and production of controlled substances,
18 other drugs or devices or cosmetics nor the authority of the
19 council in performing any duties imposed upon it by the
20 "Pennsylvania Drug and Alcohol Abuse Act."
21 Section 35. Promulgation of Regulations.--The secretary
22 shall have the authority to promulgate in accordance with the
23 provisions of this section and of the act of July 31, 1968 (Act
24 No. 240), known as the "Commonwealth Documents Law" any
25 regulations hereinbefore referred to in this act and such other
26 regulations with the consent of the board regarding the
27 possession, distribution, sale, purchase or manufacture of
28 controlled substances, other drugs or devices or cosmetics as
29 may be necessary to aid in the enforcement of this act.
30 Section 36. Administrative Procedure.--The Administrative
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1 Agency Law, as amended, shall be applicable in its entirety to
2 the Department of Health in the administration of this act.
3 Section 37. Cooperative Agreements and Confidentiality.--(a)
4 The secretary shall cooperate with Federal and other State
5 agencies in discharging his responsibilities concerning traffic
6 in controlled substances, other drugs, devices and cosmetics and
7 in suppressing the abuse of such substances and articles. To
8 this end, he may:
9 (1) Arrange for the exchange of information among
10 governmental officials concerning the use and abuse of such
11 substances and articles;
12 (2) Coordinate and cooperate in training programs concerning
13 law enforcement at local and State levels;
14 (3) Request the Federal Bureau of Narcotics and Dangerous
15 Drugs to establish a centralized unit to collect, accept,
16 catalogue and file nonconfidential statistics and make the
17 information available for Federal, State and local law
18 enforcement purposes; and
19 (4) Conduct programs of eradication aimed at destroying wild
20 or illicit growth of plant species from which drugs may be
21 extracted.
22 (b) Results, information, and evidence received from the
23 bureau relating to the regulatory functions of this act,
24 including results of inspections conducted by it may be relied
25 and acted upon by the secretary in the exercise of his
26 regulatory functions under this act.
27 (c) A practitioner engaged in medical practice or clinical
28 research is not required nor may he be compelled to furnish the
29 name or identity of a patient or research subject to the
30 secretary, nor may he be compelled in any State or local civil,
19710H0851B2698 - 64 -
1 criminal, administrative, legislative or other proceedings to
2 furnish the name or identity of such an individual.
3 (d) This section shall not exempt the practitioner from
4 regulations of the secretary pertaining to the prescription of
5 controlled substances to a patient over an extended period or in
6 an increasingly large dosage.
7 Section 38. Savings Provision.--The provisions of this act
8 shall not affect any act done, liability incurred, or right
9 accrued or vested, or affect any suit or prosecution pending to
10 enforce any right or penalty or punish any offense under the
11 authority of any Act of Assembly, or part thereof, repealed by
12 this act.
13 Section 39. Pending Proceedings.--(a) Prosecution for any
14 violation of law occurring prior to the effective date of this
15 act is not affected or abated by this act. In any case not yet
16 final if the offense is similar to one set out in this act, the
17 penalties under this act apply if they are less than those under
18 prior law.
19 (b) Civil seizures or forfeitures and injunctive proceedings
20 commenced prior to the effective date of this act are not
21 affected by this act.
22 (c) All administrative proceedings pending under prior laws
23 which are superseded by this act shall be continued and brought
24 to a final determination in accord with the laws and rules in
25 effect prior to the effective date of the act. Any substance
26 controlled under prior law which is not listed within Schedules
27 I through V, is automatically controlled without further
28 proceedings and shall be listed in the appropriate schedule.
29 (d) The secretary shall initially permit persons to register
30 who own or operate any establishment engaged in the manufacture
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1 or distribution of any controlled substance prior to the
2 effective date of this act and who are registered or licensed by
3 this Commonwealth.
4 (e) This act applies to violations of law, seizures and
5 forfeitures, injunctive proceedings, administrative proceedings
6 and investigations which occur following its effective date.
7 Section 40. Continuation of Regulations.--Any orders and
8 regulations promulgated under any law affected by this act and
9 in effect on the effective date of this act and not in conflict
10 with it continue in effect until modified, superseded or
11 repealed.
12 Section 41. Uniformity of Interpretation.--This act shall be
13 so applied and construed as to effectuate its general purpose to
14 make uniform the law with respect to the subject of this act
15 among those states which enact similar legislation.
16 Section 42. Bar to Prosecution.--If a violation of this act
17 is a violation of a Federal law or the law of another state, a
18 conviction or acquittal under Federal law or the law of another
19 state for the same act is a bar to prosecution in this
20 Commonwealth.
21 Section 43. 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.
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