Current through Register Vol. 54, No. 40, October 5, 2024
Section 25.55 - Dispensing(a) Where the pharmacist is to substitute a less expensive generically equivalent drug for a brand name drug at the pharmacy, notification to the person presenting the prescription shall be made by the pharmacist, either directly or through a pharmacy intern or other person under the supervision of the pharmacist authorized to assist the pharmacist by the State Board of Pharmacy. Such notification shall be limited to advising the person presenting the prescription that substitution is possible, to advising the person of the amount of the retail price difference between the brand name and the generically equivalent drug product substituted for it, and to informing the person that he may refuse the substitution. Questions by the person presenting the prescription for drug product information shall be answered only by the pharmacist or pharmacy intern. The notification described in this subsection of a possible substitution and retail price difference may be oral or may be in a written statement similar to the following: "Your physician has indicated that this prescription, identified as _______, may be filled with one of the generic drug products listed in the Pennsylvania Department of Health Formulary. This lower cost generically equivalent product has been selected by our pharmacy in order to save you, the purchaser, a total of $ _______. Please indicate whether you do [] or do not [] wish to have the lower priced drug. Signed ________________.''(b) Where the pharmacist is to substitute a less expensive generically equivalent drug product for a brand name drug by mail, the following provisions must be complied with: (1) The mail order pharmacy, in all communications in connection with the solicitations of mail order customers, whether by direct mailings, general advertising, or on order forms, shall include notice in upper case letters and in boldface type as follows: PENNSYLVANIA LAW PERMITS PHARMACISTS TO SUBSTITUTE A LESS EXPENSIVE GENERICALLY EQUIVALENT DRUG FOR A BRAND NAME DRUG UNLESS YOU OR YOUR PHYSICIAN DIRECT OTHERWISE.
[] CHECK HERE IF YOU DO NOT WISH A LESS EXPENSIVE BRAND OR GENERIC DRUG "PRODUCT."
(2) After receiving a prescription order by mail, a mail order pharmacy shall substitute a less expensive generically equivalent drug product listed in the Formulary unless expressly directed otherwise by the person presenting the prescription or the prescribing physician.(3) When a generically equivalent drug product is dispensed by mail, the pharmacy shall notify the person presenting the prescription of the substitution and shall indicate the retail price difference between the brand name drug and the generic equivalent drug product substituted for it.(c) Any pharmacist substituting a less expensive drug product shall charge the person presenting the prescription the regular and customary retail price of that pharmacy for the generically equivalent drug.(d) No pharmacist shall substitute a generically equivalent drug product for a prescribed brand name drug product if the brand name drug product or the generic drug type is not included in the Formulary developed by the Department and found at § 25.58 (relating to generically equivalent drug products).(e) Prescription refills, where permitted by the practitioner, shall be completed using the identical product (same distributor and manufacturer) as dispensed on the original, unless the person presenting the prescription and the practitioner authorize in advance a different manufacturer's generic equivalent product. Advance authorization is not required in an emergency, but the physician shall be notified by the pharmacist as soon as possible thereafter.The provisions of this §25.55 amended June 24, 1977, effective 6/25/1977, 7 Pa.B. 1742.The provisions of this §25.55 issued under section 5(a) of the act of November 24, 1976 (P. L. 1163, No. 259) (35 P. S. § 960.5).
This section cited in 28 Pa. Code § 551.3 (relating to definitions); 49 Pa. Code §18.6a (relating to prescribing, dispensing and administering drugs); 49 Pa. Code §18.158 (relating to prescribing and dispensing drugs); 49 Pa. Code §25.177 (relating to prescribing and dispensing drugs, pharmaceutical aids and devices); 49 Pa. Code §21.284a (relating to prescribing and dispensing drugs); and 49 Pa. Code §43b.7 (relating to schedule of civil penalties-pharmacists and pharmacies).