49 Pa. Code § 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.
Notes
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).
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