§ 27.505. Repositories.
(a) Donation site receipt. An approved participating pharmacy shall designate an area within the pharmacy at which its licensed pharmacist shall personally receive delivery from the donor or its designee, and provide the donor or its designee with written acknowledgement of any donation of a cancer drug.
(b) Donation site compliance. An approved participating pharmacy that accepts donated cancer drugs under the Cancer Drug Repository Program shall comply with all applicable Federal and State laws relating to the storage, distribution, dispensing, disposal and destruction of cancer drugs and visually inspect all cancer drugs prior to dispensing in a manner as to be able to reasonably determine if they are adulterated or misbranded. The cancer drugs shall only be dispensed by a licensed pharmacist according to State law pursuant to a prescription issued by a prescribing practitioner. The cancer drugs may be distributed to another participating physician’s office, pharmacy, hospital, health care facility or health clinic for dispensing by a pharmacist as allowed by Federal or State law.
(c) Disposition. The approved participating pharmacy repository shall destroy or dispose of donated drugs in a manner in compliance with applicable Federal and State laws if they are not accepted into the Cancer Drug Repository Program for the purpose of dispensing. A record of destruction or disposal of donated drugs that are not accepted or dispensed under the Cancer Drug Repository Program shall be maintained by the participating pharmacy for at least 2 years, and include the following:
(1) The date of destruction.
(2) The name, strength and quantity of the cancer drug destroyed.
(3) The name of the person or firm that destroyed the drug.
(4) The source of the drugs destroyed.
(d) Storage. Drugs received in the Cancer Drug Repository Program shall be stored separately from the rest of the approved participating pharmacy’s stock.
(e) Informed consent. Prior to dispensing a cancer drug in its Cancer Drug Repository Program, an approved participating pharmacy shall inform the patient that the drug was previously dispensed but was unused and then donated to the approved participating pharmacy in the drug’s original unopened, sealed and tamper-evident unit dose packaging to be restocked and redistributed. The approved participating pharmacy may not dispense the drug if the patient does not sign a cancer drug repository informed consent form as supplied by the Board. The informed consent form shall be maintained for at least 2 years after the patient signs it. The form must include the following information:
(1) The drug being dispensed has been donated and may have been previously dispensed.
(2) The drug was unused, although previously dispensed.
(3) The drug was donated to the approved participating pharmacy in the drug’s original unopened, sealed and tamper-evident packaging to be restocked and redistributed.
(4) A visual inspection has been conducted by the pharmacist in a manner as to be able to reasonably determine that the drug has not expired, has not been adulterated or misbranded, and is in its original unopened, sealed and tamper-evident packaging.
(5) The dispensing pharmacist, the prescribing or administering practitioner, the cancer drug repository, the Board and any other participant of the Cancer Drug Repository Program cannot guarantee the safety of the drug being dispensed or administered, and that the pharmacist has determined that the drug appears to be safe to dispense or administer based on the accuracy of the donor’s form submitted with the donated drug and the visual inspection required to be performed by the pharmacist before dispensing or administering.
(f) Recordkeeping. Drugs used in the Cancer Drug Repository Program must be easily auditable and every dose accounted for by the approved participating pharmacy’s maintenance of recordkeeping meeting the following requirements:
(1) The approved participating pharmacy must record receipt of the drug on a repository donor form as developed by the Board.
(2) The approved participating pharmacy must record dispensing the drug on a repository dispensing form as developed by the Board.
(3) The approved participating pharmacy shall record the following information for all cancer drugs received, dispensed and distributed or disposed of or destroyed in the Cancer Drug Repository Program:
(i) Name and strength of the cancer drug.
(ii) Quantity of the cancer drug.
(iii) Expiration date of the cancer drug.
(iv) Lot number of the cancer drug.
(v) Name of pharmacy that originally dispensed the cancer drug.
(vi) Name of the donor of the cancer drug.
(vii) Name of the person to whom the cancer drug was originally prescribed.
(viii) Name of the person to whom the cancer drug was dispensed.
(ix) Date the cancer drug was dispensed.
(x) Name of the prescribing practitioner who wrote the prescription for the cancer drug to be dispensed under the Cancer Drug Repository Program.
(xi) Date the cancer drug was disposed of or destroyed.
(xii) Whether a handling fee was charged and the amount of the fee.
(4) The approved participating pharmacy shall maintain records required under this section for at least 2 years.
(g) Handling fee. An approved participating pharmacy may charge a handling fee for distributing or dispensing cancer drugs under the Cancer Drug Repository Program, not to exceed 250% of the Medical Assistance dispensing fee more specifically set forth in the Method of Payment for Pharmaceutical Services provided in 55 Pa. Code Chapter 1121 (relating to pharmaceutical services). (See 55 Pa. Code § 1121.55 (relating to method of payment).) Cancer drugs donated under the Cancer Drug Repository Program may not be resold.
(h) Theft and diversion. An approved participating pharmacy shall develop, implement and enforce a policy to deter and minimize theft and diversion of cancer drugs it receives in the form of donations made under the Cancer Drug Repository Program.
Authority The provisions of this § 27.505 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 § 27.505 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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