§ 27.503. Participation in the Cancer Drug Repository Program.
(a) Participation. A pharmacy holding a current unrestricted permit may apply for approval to participate in the Cancer Drug Repository Program as an approved cancer drug repository as provided in this chapter.
(b) Application. A pharmacy may apply for approval to participate in the Cancer Drug Repository Program by submitting the following information to the Board, on a form provided by the Board:
(1) The name, street address and telephone number of the pharmacy.
(2) Identification and background information of the pharmacy’s ownership.
(3) A description of all pharmacy services provided and the location and manner in which those services are provided.
(4) A certification by a licensed pharmacist who is employed by or under contract with the pharmacy that the pharmacy meets the eligibility requirements for participation in the Cancer Drug Repository Program under subsection (c).
(5) The name and telephone number of the licensed pharmacist employed by or under contract with the pharmacy who made the certification required under paragraph (4).
(c) Eligibility. A pharmacy is eligible to participate in the Cancer Drug Repository Program if the pharmacy:
(1) Holds a current unrestricted permit in good standing to operate as a pharmacy in this Commonwealth.
(2) Delegates to a licensed pharmacist employed by or under contract with the pharmacy the responsibility to receive delivery of donated cancer drugs at the designated delivery area in the pharmacy.
(3) Agrees to participate in the Cancer Drug Repository Program in accordance with the act, this chapter and the Cancer Drug Repository Program Act (62 P. S. § § 2921—2927).
(d) Donations of cancer drugs.
(1) A pharmacy, health care facility, drug manufacturer or wholesale drug distributor may donate legally obtained cancer drugs to an approved participating pharmacy if the drugs meet the eligibility requirements under § 27.504(relating to drugs) as determined by a licensed pharmacist employed by or under contract with an approved participating pharmacy.
(2) To be considered for donation, a cancer drug must be accompanied by a cancer drug repository donor form on a form provided by the Board that:
(i) Is signed by the entity’s authorized representative.
(ii) States that to the best of the donor’s knowledge the donated drug has been properly stored and that the drug has never been opened, used, tampered with, adulterated or misbranded.
(e) Changes in approval status. The Board may refuse, revoke or suspend approval of a pharmacy’s participation in the Cancer Drug Repository Program upon proof satisfactory to it that the pharmacy has violated the Cancer Drug Repository Program Act, the act, or any Federal or State law, rule or regulation.
Authority The provisions of this § 27.503 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).
Source The provisions of this § 27.503 adopted November 27, 2013, effective November 30, 2013, 43 Pa.B. 7011.
Cross References This section cited in 49 Pa. Code § 27.501 (relating to purpose); and 49 Pa. Code § 27.502 (relating to definitions).
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