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 19900H2635B3889 - 2 -
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 19900H2635B3889 - 3 -
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, 19900H2635B3889 - 4 -
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. E17L35JLW/19900H2635B3889 - 5 -