PRINTER'S NO. 522
No. 473 Session of 1975
INTRODUCED BY TOLL, A. K. HUTCHINSON, GILLETTE, BARBER,
SCHEAFFER, TRELLO, COHEN, FEE, JOHNSON, TADDONIO, KATZ,
GREENFIELD, RIEGER, CESSAR, ROMANELLI, ABRAHAM, SHUPNIK,
MUSTO, OLIVER, GIAMMARCO, USTYNOSKI, BLACKWELL, RICHARDSON
AND PIEVSKY, FEBRUARY 18, 1975
REFERRED TO COMMITTEE ON HEALTH AND WELFARE, FEBRUARY 18, 1975
AN ACT
1 Creating the Drug Utilization Review Council in the Department
2 of Health; requiring the compilation of a list of
3 interchangeable drugs; imposing duties on pharmacists;
4 authorizing physicians to permit substitutions and imposing
5 penalties.
6 The General Assembly of the Commonwealth of Pennsylvania
7 hereby enacts as follows:
8 Section 1. Definitions.--As used in this act:
9 "Bioavailability" means the extent and rate of absorption
10 from a dosage form as reflected by the time-concentration curve
11 of the administered drug in the systemic circulation.
12 "Bioequivalents" mean chemical equivalents which, when
13 administered to the same individuals in the same dosage regimen,
14 will result in comparable bioavailability.
15 "Brand name" means the proprietary name assigned to a drug by
16 the manufacturer thereof.
17 "Chemically equivalent" means drug products that contain the
1 same amounts of the same therapeutically active ingredients in
2 the same dosage forms and that meet present compendial
3 standards.
4 "Council" means the Drug Utilization Review Council.
5 "Drug product" means a dosage form containing one or more
6 active therapeutic ingredients along with other substances
7 included during the manufacturing process.
8 "Established name" with respect to a drug or ingredient
9 thereof, means (i) the applicable official name designated
10 pursuant to the Federal Food, Drug and Cosmetic Act (Title 21,
11 USC 301 et seq.), or (ii) if there is no such official name and
12 such drug or ingredient is recognized in an official compendium,
13 then the official title thereof in such compendium, except that
14 where a drug or ingredient is recognized in the United States
15 Pharmacopoeia and in the Homeopathic Pharmacopoeia under
16 different official titles, the official title used in the United
17 States Pharmacopoeia shall apply unless it is labeled and
18 offered for sale as a homeopathic drug, in which case the
19 official title used in the Homeopathic Pharmacopoeia shall
20 apply, or (iii) if neither (i) nor (ii) is applicable, then the
21 common or usual name, if any, of such drug or ingredient.
22 "Interchangeable drug products" mean pharmaceutical
23 equivalents or bioequivalents that are determined to be
24 therapeutic equivalents by the council.
25 "Pharmaceutical equivalents" mean those drug products that
26 contain the same amounts of the same therapeutically active
27 ingredients in the same dosage form and that meet standards to
28 be established on the basis of the best available technology.
29 "Prescription" means an order for drugs or combinations or
30 mixtures thereof, written or signed by a duly licensed
19750H0473B0522 - 2 -
1 physician, dentist, veterinarian or other practitioner licensed
2 to write prescriptions intended for the treatment or prevention
3 of disease in man or animals, and includes orders for drugs or
4 medicines or combinations or mixtures thereof transmitted to
5 pharmacists through word of mouth, telephone, telegraph or other
6 means of communication by a duly licensed physician, dentist,
7 veterinarian or other practitioner licensed to write
8 prescriptions intended for the treatment or prevention of
9 disease in man or animals.
10 "Present compendial standards" mean the official standards
11 for drug excipients and drug products listed in the latest
12 revision of the United States Pharmacopoeia (USP) and the
13 National Formulary (NF).
14 "Reference drug product" means the product which is adopted
15 by the council as the standard for other chemically equivalent
16 drugs in terms of testing for the therapeutic equivalence. In
17 all cases, the reference drug product shall be a currently
18 marketed drug which is the subject of a full (not abbreviated)
19 new drug application approved by the Federal Food and Drug
20 Administration.
21 "Therapeutic equivalents" mean chemical equivalents which,
22 when administered to the same individuals in the same dosage
23 regimen, will provide essentially the same efficacy or toxicity.
24 Section 2. Drug Utilization Review Council Created.--(a)
25 There is hereby established in the Department of Health a Drug
26 Utilization Review Council to consist of eight members appointed
27 by the Governor, and the Secretary of Health or his designee. Of
28 the members to be appointed by the Governor, two shall be
29 licensed pharmacists, two shall be licensed physicians, two
30 shall be persons with professional scientific or research
19750H0473B0522 - 3 -
1 experience in pharmacology, and two shall be members of the
2 general public. The members appointed by the Governor shall
3 serve for a term of five years and until their successors have
4 been appointed and qualified, but of those first appointed, two
5 shall be appointed for a term of two years, two for a term of
6 three years, two for a term of four years, and two for a term of
7 five years.
8 (b) Vacancies shall be filled in the same manner as the
9 original appointments but only for the unexpired term. Council
10 members shall serve without compensation but the members
11 appointed by the Governor shall be entitled to reimbursement for
12 any necessary and reasonable expenses incurred in the
13 performance of their duties hereunder, provided that the amount
14 of such reimbursement shall not exceed $1,000 annually.
15 (c) The council shall meet annually and elect a chairman and
16 secretary from among its members. The chairman and secretary
17 shall serve for a term of one year. The council shall meet at
18 such other times to carry out its functions and duties at the
19 call of the chairman or a majority of its members. The council
20 shall be entitled to employ such advisory, technical, and
21 clerical personnel as it deems necessary within the limits of
22 any appropriations made available therefor.
23 Section 3. List of Interchangeable Drug Products.--(a) The
24 council shall prepare a list of interchangeable drug products.
25 This list shall be periodically reviewed in accordance with a
26 schedule of and procedure for such review as shall be
27 established by the council. In development of the list,
28 distinctions shall be made when: (i) evidence of bioequivalence
29 is considered critical and when it is not; (ii) when levels of
30 toxicity are considered critical and when they are not. The list
19750H0473B0522 - 4 -
1 may include interchangeable drug products used by the United
2 States Government and its agencies, where the government or such
3 agency has established the reliability of the drug products
4 interchanged.
5 (b) No drug product shall be included in such list until
6 after a public hearing has been held thereon after at least 20
7 days' notice. Such notice shall be mailed to every drug company
8 that is authorized to do business in the Commonwealth of
9 Pennsylvania and to all persons who have made a timely request
10 of the council for advance notice of its public hearings and
11 shall be published in the Pennsylvania Bulletin.
12 (c) Manufacturers shall, upon the request of the council, be
13 required to submit any information in their files that relates
14 manufacturing processes and in vivo and in vitro tests to the
15 bioavailability of any drug product. This requirement shall also
16 apply to technical information obtained during research related
17 to the development of new drug products, even when such
18 information bears only an indirect relationship to the final
19 dosage form. The council shall not make such information public
20 when there is a proprietary interest on the part of the
21 manufacturer.
22 (d) Any manufacturer of drug products shall have the right
23 to request the council to evaluate its drug products for the
24 purpose of inclusion on the list of interchangeable drug
25 products, or to request that the council consider removal of any
26 drug product from the list. Any such request shall be
27 accompanied by such information as the council shall require,
28 and any drug product involved shall be evaluated in the same
29 manner and shall be subject to the same procedures and
30 requirements as all other drug products evaluated by the council
19750H0473B0522 - 5 -
1 for inclusion on or removal from the list.
2 (e) Prior to any drug product being approved by the council,
3 the manufacturer shall be required to demonstrate that it has
4 complied with the standards set forth in the Current Good
5 Manufacturing Practices of Title 21 USC and must show evidence
6 of a satisfactory inspection by the Federal Food and Drug
7 Administration.
8 (f) The council shall distribute copies of the list of
9 interchangeable drug products and revisions thereof and
10 additions thereto among physicians and other authorized
11 prescribers and licensed pharmacists, and shall supply a copy of
12 any person upon request, upon payment of the price established
13 by the council.
14 (g) The council shall be authorized to adopt reasonable
15 rules and regulations to carry out its functions and duties
16 under this act and to effectuate its purposes.
17 Section 4. Contents of Prescription Blanks.--Every
18 prescription blank shall be imprinted with the words
19 "substitution permissible" and "do not substitute" and shall
20 contain space for the physician's or other authorized
21 prescriber's initials next to the chosen option. Notwithstanding
22 any other law, unless the physician or other authorized
23 prescriber explicitly states that there shall be no substitution
24 when transmitting an oral prescription or, in the case of a
25 written prescription, indicates that there shall be no
26 substitution by initialing the prescription blank next to "do
27 not substitute," a different brand name or nonbrand name drug
28 product of the same established name shall be dispensed by a
29 pharmacist if such different brand name or nonbrand name drug
30 product shall reflect a lower cost to the consumer and is
19750H0473B0522 - 6 -
1 contained in the latest list of interchangeable drug products
2 published by the council, provided, however, that such action by
3 the pharmacist shall be authorized only if in each case the
4 pharmacist indicates on the prescription and immediately
5 transmits notice, either orally or by written notice to be
6 mailed no later than the end of the business day, to the
7 prescriber specifying the drug product actually dispensed and
8 the name of the manufacturer thereof. However, no drug
9 interchange shall be made unless a savings to the consumer
10 results, and that savings is passed on to the consumer.
11 Section 5. Duties of Pharmacists.--Notwithstanding any other
12 law, where a different brand name or nonbrand name drug product
13 of the same established name shall reflect a lower cost to the
14 consumer and no drug product of such established name is
15 included in the latest list of interchangeable drug products
16 published by the council, or where in the professional judgment
17 of the pharmacist there is no valid proof of efficacy for the
18 drug product prescribed, or the pharmacist's patient profile
19 record discloses drug sensitivity, allergies or adverse
20 reactions to the drug product prescribed, or there exists a more
21 appropriate drug product than the drug product prescribed, a
22 different brand name or nonbrand name drug product shall be
23 dispensed by the pharmacist, provided, however, that such action
24 by a pharmacist shall be authorized only if in each case the
25 pharmacist notifies the prescriber of the drug product to be
26 dispensed and the name of the manufacturer thereof, and receives
27 the approval of the prescriber to substitute such drug product
28 for the drug product prescribed. The pharmacist shall be
29 required to indicate on the prescription the date and time of
30 the prescriber's approval and whether the approval was
19750H0473B0522 - 7 -
1 communicated orally or in writing.
2 Section 6. Use of Nonbrand Name Drug Products.--If a
3 nonbrand name drug product is dispensed, the pharmacist shall
4 include on the label of such drug product dispensed pursuant to
5 a prescription the established name and the name of the
6 manufacturer, except where the prescriber indicates to the
7 contrary on the prescription.
8 Section 7. Penalties.--Any person violating any provision of
9 this act upon conviction in a summary proceeding shall be liable
10 to a penalty of not less than $100 for the first offense, and
11 not less than $200 for each subsequent offense.
B11L32RW/19750H0473B0522 - 8 -