PRIOR PRINTER'S NO. 3637 PRINTER'S NO. 3889
No. 2635 Session of 1990
INTRODUCED BY ITKIN, KUKOVICH, DeWEESE, PIEVSKY, COHEN,
TANGRETTI, STUBAN, MERRY, BATTISTO, DIETTERICK, FAIRCHILD,
BILLOW, MELIO, HERSHEY, TELEK, JOHNSON AND TRELLO,
JUNE 4, 1990
AS AMENDED ON THIRD CONSIDERATION, HOUSE OF REPRESENTATIVES,
JUNE 27, 1990
AN ACT
1 Amending the act of November 24, 1976 (P.L.1163, No.259),
2 entitled "An act relating to the prescribing and dispensing
3 of generic equivalent drugs," requiring the department to
4 publish notice of approved generically equivalent drugs.
5 The General Assembly of the Commonwealth of Pennsylvania
6 hereby enacts as follows:
7 Section 1. The definition of "generically equivalent drug"
8 in section 2 of the act of November 24, 1976 (P.L.1163, No.259),
9 referred to as the Generic Equivalent Drug Law, is amended to
10 read:
11 Section 2. As used in this act:
12 * * *
13 "Generically equivalent drug" means a drug product [having
14 the same generic name, dosage form and labeled potency, meeting
15 standards of the United States Pharmacopoeia or National
16 Formulary or their successors, if applicable, and not found in
17 violation of the requirements of the United States Food and Drug
1 Administration or the Pennsylvania Department of Health.] that
2 the Commissioner of Food and Drugs of the United States Food and
3 Drug Administration has approved as safe and effective and has
4 determined to be therapeutically equivalent, as listed in "The
5 Approved Drug Products with Therapeutic Equivalence
6 Evaluations," (Food and Drug Administration "Orange Book"), BUT <--
7 DOES NOT MEAN A DRUG PRODUCT FOUND ON THE UNITED STATES FOOD AND
8 DRUG ADMINISTRATION'S LIST OF NARROW THERAPEUTIC RANGE DRUGS
9 UNLESS APPROVED BY THE SECRETARY, WITH THE ADVICE OF THE
10 PENNSYLVANIA DRUG, DEVICE AND COSMETIC BOARD.
11 * * *
12 Section 2. Section 3(a) and (f) of the act, amended December
13 15, 1988 (P.L.1257, No.154), are amended to read:
14 Section 3. (a) Whenever a pharmacist receives a
15 prescription for a brand name drug [he shall, unless requested
16 otherwise by the purchaser, substitute a less expensive
17 generically equivalent drug product listed in the formulary of
18 generic and brand name drug products developed by the Department
19 of Health as provided in section 5(b) unless the prescriber
20 indicates otherwise.] the pharmacist shall substitute a less
21 expensive generically equivalent drug unless requested otherwise
22 by the purchaser or indicated otherwise by the prescriber. The
23 bottom of every prescription blank shall be imprinted with the
24 words "substitution permissible" and shall contain one signature
25 line for the physician's or other authorized prescriber's
26 signature. The prescriber's signature shall validate the
27 prescription and, unless the prescriber handwrites "brand
28 necessary" or "brand medically necessary," shall designate
29 approval of substitution of a drug by a pharmacist pursuant to
30 this act. Imprinted conspicuously on the prescription blanks
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1 shall be the words: "In order for a brand name product to be
2 dispensed, the prescriber must handwrite 'brand necessary' or
3 'brand medically necessary' in the space below." All information
4 printed on the prescription blank shall be in eight-point
5 uppercase print. In the case of an oral prescription, there will
6 be no substitution if the prescriber expressly indicates to the
7 pharmacist that the brand name drug is necessary and
8 substitution is not allowed. Substitution of a less expensive
9 generically equivalent drug [product] shall be contingent on
10 whether the pharmacy has the brand name or generically
11 equivalent drug in stock.
12 * * *
13 (f) No pharmacist shall substitute a generically equivalent
14 drug [product for a prescribed brand name drug product if the
15 brand name drug product or the generic drug type is not included
16 in the formulary developed by the Department of Health in
17 accordance with the provisions of section 5(b).] for a
18 prescribed brand name drug unless the generically equivalent
19 drug meets the definition of generically equivalent drug set
20 forth in this act and the secretary has not prohibited the use
21 of the drug in accordance with section 5.
22 Section 3. Sections 4(b) and 5 of the act are amended to
23 read:
24 Section 4. * * *
25 (b) Every pharmacy shall post in a conspicuous place, easily
26 accessible to the general public, a list of commonly used
27 generically equivalent drugs [from the formulary] containing the
28 generic names and brand names where applicable.
29 * * *
30 Section 5. (a) The Department of Health shall have the
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1 power and its duty shall be to:
2 (1) Administer and enforce the provisions of this act.
3 (2) Adopt necessary regulations consistent with this act.
4 (3) Publicize the provisions of this act.
5 (4) [Distribute in cooperation with the Pennsylvania Board
6 of Pharmacy periodically an updated formulary of generically
7 equivalent drug products to all pharmacies in the Commonwealth.]
8 Publish by notice in the Pennsylvania Bulletin the addition or
9 deletion of generically equivalent drugs and any determination
10 by the secretary to not recognize a generically equivalent drug
11 in accordance with section 5(b). The department shall also
12 provide notice that a complete list of generically equivalent
13 drugs may be obtained from the United States Food and Drug
14 Administration. This notice shall be published at least every
15 three months.
16 (b) [The Secretary of Health in cooperation with the
17 Pennsylvania Drug, Device and Cosmetic Board shall within 180
18 days of the effective date of this act establish a formulary of
19 generically equivalent drugs and the name of their
20 manufacturers. In compiling the list of generic and brand name
21 drug products for inclusion in the formulary, the secretary may
22 adopt in whole or in part formularies adopted by the United
23 States Department of Health, Education and Welfare for their
24 maximum allowable cost program for drug reimbursements under
25 Title XVIII and Title XIX of the Social Security Act. In the
26 event of an emergency, as determined by the secretary to affect
27 the health or safety of the public, the secretary may remove a
28 drug product from the list without public hearings. If the
29 formulary for the maximum allowable cost program is adopted by
30 the secretary, formal hearings as required in the act of June 4,
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1 1945 (P.L.1388, No.422), known as the "Administrative Agency
2 Law," may be waived otherwise the inclusions of all drugs in the
3 formulary shall be in compliance with the provisions of the
4 Administrative Agency Law. The formulary may be added to or
5 deleted from upon the motion of the secretary or on the petition
6 of any interested party however before such addition or deletion
7 the secretary shall request the advice in writing from the Drug,
8 Device and Cosmetic Board whether a drug should be added or
9 deleted. Such advice shall be rendered to the secretary within a
10 reasonable time. After considering the available facts, the
11 secretary shall make a finding with respect to such drug and may
12 issue a regulation on its substitution for a period of one year.
13 The status of such drugs as well as the formulary shall be
14 reviewed annually by the secretary.] The secretary, with the
15 advice of the Pennsylvania Drug, Device and Cosmetic Board, may
16 determine that a drug shall not be recognized as a generically
17 equivalent drug for purposes of substitution in Pennsylvania and
18 the time after which recognition shall be restored.
19 Section 4. This act shall take effect in 60 days.
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