49 Pa. Code § 27.602 - Compounding prohibited

Pharmacists may not compound any of the following:

(1) Drugs that have been identified by the FDA as withdrawn or removed from the market because the drugs were found to be unsafe or ineffective as set forth in 21 CFR 216.24 (relating to drug products withdrawn or removed from the market for reasons of safety or effectiveness) unless the drug is being used as part of a clinical trial and is approved by an institution's institutional review board.

(2) Drugs that are essentially copies of a commercially available drug product, except as provided in section 503a(b)(1)(D) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.A. § 353a(b)(1)(D)).

(3) Drugs that have been identified by the FDA in the Federal Food, Drug, and Cosmetic Act (21 U.S.C.A. §§ 301-399h) or the Code of Federal Regulations as products which may not be compounded.

Notes

49 Pa. Code § 27.602

The provisions of this § 27.602 adopted June 21, 2019, effective 6/22/2019, 49 Pa.B. 3210.

The provisions of this § 27.602 issued under sections 4(j) and 6(k)(1) and (9) of the Pharmacy Act (63 P.S. §§ 390-4(j) and 390-6(k)(1) and (9)).