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§ 960.3. Substitutions

Purdon's Pennsylvania Statutes and Consolidated StatutesTitle 35 P.S. Health and SafetyEffective: September 19, 2016

Purdon's Pennsylvania Statutes and Consolidated Statutes
Title 35 P.S. Health and Safety (Refs & Annos)
Chapter 6B. Drugs, Poisons and Dangerous Substances
Generic Equivalent Drug Law (Refs & Annos)
Effective: September 19, 2016
35 P.S. § 960.3
§ 960.3. Substitutions
(a) Whenever a pharmacist receives a prescription for a brand name drug, the pharmacist shall substitute a less expensive generically equivalent drug unless requested otherwise by the purchaser or indicated otherwise by the prescriber. The bottom of every prescription blank shall be imprinted with the words “substitution permissible” and shall contain one signature line for the physician's or other authorized prescriber's signature. The prescriber's signature shall validate the prescription and, unless the prescriber handwrites “brand necessary” or “brand medically necessary,” shall designate approval of substitution of a drug by a pharmacist pursuant to this act. Imprinted conspicuously on the prescription blanks shall be the words: “In order for a brand name product to be dispensed, the prescriber must handwrite ‘brand necessary’ or ‘brand medically necessary’ in the space below.” All information printed on the prescription blank shall be in eight-point uppercase print. In the case of an oral prescription, there will be no substitution if the prescriber expressly indicates to the pharmacist that the brand name drug is necessary and substitution is not allowed. Substitution of a less expensive generically equivalent drug shall be contingent on whether the pharmacy has the brand name or generically equivalent drug in stock.
(a.1) A pharmacist may substitute a biological product for a prescribed biological product only if:
(1) the biological product is an interchangeable biological product and has been determined by the United States Food and Drug Administration to be interchangeable with the prescribed product;
(2) the prescriber does not designate verbally or in writing on the prescription that substitution is prohibited; and
(3) the person presenting the prescription receives notification of such substitution in the same manner provided in subsection (b).
(a.2) Within 72 hours following the dispensing of an interchangeable biological product, the dispensing pharmacist or the pharmacist's designee shall communicate to the prescriber the specific product provided to the patient, including the name of the product and the manufacturer. The communication shall be conveyed by making an entry in the electronic health record of the patient, as defined in the act of July 5, 2012 (P.L. 1042, No. 121),1 known as the “Pennsylvania eHealth Information Technology Act,” or through an electronic prescribing technology, a pharmacy benefit management system or a pharmacy record, that is electronically accessible by the prescriber. Entry into an electronic records system as described in this subsection is presumed to provide notice to the prescriber. Otherwise, within 72 hours, the pharmacist shall communicate the interchangeable biological product dispensed to the prescriber, using facsimile, telephone, electronic transmission or other prevailing means, provided that the communication shall not be required where:
(1) there is no United States Food and Drug Administration-approved interchangeable biological product for the biological product prescribed; or
(2) it is a refill prescription where the interchangeable biological product dispensed is the same interchangeable biological product which was dispensed at the prior filling of the prescription.
(a.3) Subsections (a.1) and (a.2) may not apply to a biological product which may be dispensed without a prescription.
(b) Any pharmacist who substitutes any drug shall notify the person presenting the prescription of such substitution together with the amount of the retail price difference between the brand name and the drug substituted for it and shall inform the person presenting the prescription that they may refuse the substitution.
(c) Any pharmacist substituting a less expensive drug product or interchangeable biological product shall charge the purchaser the regular and customary retail price for the generically equivalent drug or interchangeable biological product.
(d) Each pharmacist shall maintain a record of any substitution of a generically equivalent drug product or interchangeable biological product for a prescribed brand name drug.
(e) Unless the prescriber directs otherwise, the label on all drugs dispensed by a pharmacist shall indicate the generic name using abbreviations if necessary and the name of the manufacturer. The same notation shall be made on the original prescription retained by the pharmacist.
(f) No pharmacist shall substitute a generically equivalent drug for a prescribed brand name drug unless the generically equivalent drug meets the definition of generically equivalent drug set forth in this act and the secretary has not prohibited the use of the drug in accordance with section 5.2


1976, Nov. 24, P.L. 1163, No. 259, § 3, imd. effective. Amended 1988, Dec. 15, P.L. 1257, No. 154, § 1, effective July 1, 1989; 1990, July 11, P.L. 509, No. 121, § 2, effective in 60 days; 2016, July 20, P.L. 830, No. 95, § 2, effective in 60 days [Sept. 19, 2016].


35 P.S. § 510.101 et seq. (repealed); see 62 P.S. § 1401-C et seq.
35 P.S. § 960.5.
35 P.S. § 960.3, PA ST 35 P.S. § 960.3
Current through Act 13 of the 2024 Regular Session. Some statute sections may be more current, see credits for details.
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