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TITLE 25HEALTH SERVICES
PART 1DEPARTMENT OF STATE HEALTH SERVICES
CHAPTER 229FOOD AND DRUG
SUBCHAPTER BDONATION OF UNUSED DRUGS
RULE §229.22Donation of Drugs to Charitable Medical Clinics

A charitable medical clinic may receive a drug donated by a charitable drug donor for dispensing to a patient of the charitable medical clinic, provided that the following requirements are met.

  (1) The charitable drug donor must be licensed with the department as a wholesale drug distributor. Manufacturers who participate in a patient assistance program and physicians who donate samples will not be required to license with the department.

  (2) The donated drugs must be dangerous drugs as defined in Health and Safety Code, Chapter 483, entitled "Texas Dangerous Drug Act."

  (3) Donated drugs may not be controlled substances as defined in Health and Safety Code, Chapter 481, entitled "Texas Controlled Substances Act."

  (4) All donated drugs must be approved by the Food and Drug Administration (FDA) and intended for human use.

  (5) Donation of drug samples must comply with Title 21, Code of Federal Regulations (CFR), §203.39.

  (6) Previously dispensed drugs shall not be donated.

  (7) The charitable drug donor must verify that the requesting charity is legitimate.

    (A) Verification shall include copies of documents proving the charitable medical clinic's status as exempt from federal income tax; address, telephone number, and name of contact person at the charitable medical clinic.

    (B) Documentation of verification must be retained by the charitable drug donor for three years.

  (8) A drug donated by a charitable drug donor shall be received by a charitable medical clinic in the manufacturer's unopened original tamper-evident packaging with its labeling intact.

  (9) Delivery of a donated drug to a recipient charitable medical clinic shall be completed by an authorized agent or employee of the recipient charitable medical clinic or by the charitable drug donor. All deliveries shall be made in person. The authorized agent or employee shall present his or her official state identification to the recipient upon delivery.

  (10) The recipient charitable medical clinic shall prepare at the time of collection or delivery of drugs a complete and accurate donation record, a copy of which shall be retained by the recipient charitable medical clinic for at least three years, containing the following information:

    (A) a signed written statement from the charitable drug donor that the drugs have been properly stored in accordance with the manufacturer's instructions;

    (B) a verifiable name, address, and telephone number of the charitable drug donor;

    (C) the manufacturer, brand name, quantity, and lot or control number of the drugs donated;

    (D) the date of the donation; and

    (E) a copy of official state identification of the authorized agent or employee of the charitable drug donor.

  (11) A donated drug shall not be dispensed to a patient until it has been examined by a registered pharmacist at the recipient charitable medical clinic to confirm that the donation record accurately describes the drug delivered, and to confirm in his or her professional judgment that no drug is adulterated or misbranded for any reason including, but not limited to, the following:

    (A) the drug is out of date;

    (B) the labeling has become mutilated, obscured, or detached from the drug packaging;

    (C) the drug shows evidence of having been stored or shipped under conditions that might adversely affect its stability, integrity, or effectiveness;

    (D) the drug has been recalled or is no longer marketed; or

    (E) the drug is otherwise possibly contaminated, deteriorated, or adulterated.

  (12) Documentation of the examination of the drug and the drug donation record by the registered pharmacist shall be retained by the charitable medical clinic for three years after the date of examination.

  (13) The recipient charitable medical clinic shall dispose of any drug found to be adulterated/misbranded by destroying it. The charitable medical clinic shall retain complete records of the disposition of all destroyed drugs for three years from the date of destruction.

  (14) Each recipient charitable medical clinic shall conduct, at least annually, an inventory of drug stocks and shall prepare a report reconciling the results of each inventory with the most recent prior inventory. Drug inventory discrepancies and reconciliation problems shall be investigated by the charitable medical clinic and outcomes documented. All reports of reconciliation, investigation, and outcome shall be retained by the charitable medical clinic for three years.

  (15) All charitable drug donors shall comply with the existing statutory standards contained in the Texas Health and Safety Code, Chapter 431 and the requirements of §229.251 of this title (relating to Minimum Standards for Licensure) for "Licensing of Wholesale Distributors of Nonprescription Drugs--Including Good Manufacturing Practices."

  (16) A charitable medical clinic shall immediately notify the Drugs and Medical Devices Group at (512) 834-6755, of becoming aware of a significant loss or theft of drugs; and a copy of the inventory reconciliation, investigation, and outcome report shall be forwarded to the Drugs and Medical Devices Group, Mail Code 1987, P.O. Box 149347, Austin, TX 78714-9347 within five days of the telephone notification.

  (17) A charitable drug donor shall promptly notify in writing a charitable medical clinic to which donations have been made, if the donor becomes aware of a recall or other situation pertaining to the safety and efficacy of the previously donated drugs. Documentation of this notice shall be retained for three years after the date of notification.


Source Note: The provisions of this §229.22 adopted to be effective May 29, 2003, 28 TexReg 4153; amended to be effective December 9, 2010, 35 TexReg 10755

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