49 Pa. Code § 27.504 - Drugs

(a) Eligible drugs. Unless otherwise prohibited by Federal or State statute or regulation, a cancer drug may be accepted by a licensed pharmacist at an approved participating pharmacy for dispensing in a Cancer Drug Repository Program if the drug meets one of the following criteria:

(1) The drug is in its original unopened, sealed and tamper-evident unit dose packaging.

(2) The drug is packaged in single unit doses, when the outside original packaging is opened but the single-unit-dose packaging is unopened.

(b) Ineligible drugs. A cancer drug may not be accepted by a licensed pharmacist at an approved participating pharmacy for dispensing if the drug meets any one of the following criteria:

(1) The drug bears an expiration date that is earlier than 6 months after the date the drug will be restocked.

(2) The drug shows evidence of having been adulterated or misbranded.

(3) The drug is designated by the Drug Enforcement Agency as a controlled substance under 21 CFR Part 1308 (relating to schedules of controlled substances).

(4) The drug is subject to restricted distribution by the Food and Drug Administration under 21 CFR 314.520 or 314.610 (relating to approval with restrictions to assure safe use; and approval based on evidence of effectiveness from studies in animals).

(5) The drug requires refrigeration, freezing or other special temperature requirements beyond controlled room temperature.

(6) The drug has been previously compounded.

(c) Drug categories. Unless otherwise ineligible under this section, an approved participating pharmacy may accept a cancer drug in any of the categories of the American Hospital Formulary Service Pharmacologic-Therapeutic Classification.

(d) Recalls. An approved participating pharmacy shall handle a recall of any drug in its Cancer Drug Repository Program as if the drug had been delivered directly to the pharmacy by the manufacturer.

Notes

49 Pa. Code § 27.504

The provisions of this § 27.504 adopted November 27, 2013, effective 11/30/2013, 43 Pa.B. 7011.

The provisions of this § 27.504 issued under 6(k)(9) of the Pharmacy Act (63 P. S. § 390-6(k)(9)); and sections 3 and 7 of the Cancer Drug Repository Program Act (62 P. S. §§ 2923 and 2927).

This section cited in 49 Pa. Code § 27.501 (relating to purpose); 49 Pa. Code § 27.502 (relating to definitions); and 49 Pa. Code § 27.503 (relating to participation in the Cancer Drug Repository Program).