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RULE §229.23Donation of Drugs From Nursing Homes to Foreign Countries

A nursing home may donate certain drugs or drug samples, due for destruction, to a foreign country provided the following requirements are met.

  (1) The drugs to be donated are in the manufacturer's unopened original tamper-evident packaging with its labeling intact.

  (2) Previously dispensed drugs shall not be donated.

  (3) Controlled substances as defined in Health and Safety Code, Chapter 481, entitled "Texas Controlled Substances Act," shall not be donated.

  (4) A drug shall not be shipped to a foreign country until it has been examined by a registered pharmacist at the nursing home to confirm, in his or her professional judgment, that it is not 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    (A) the drug is out of date;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.

  (5) The nursing home shall destroy any drug or drug sample found to be unsuitable, and retain documentation for three years from the date of destruction.

  (6) Shipment. A drug described in this section may be exported to any country, if the drug complies with the laws of that country and if the nursing home has documented the prior consent of the foreign recipient. Documentation of consent shall be retained by the nursing home for three years after the date of consent. All drug donations should be packed in accordance with international shipping regulations, and be accompanied by a detailed packing list which specifies the contents of each carton and any special storage conditions. Drugs should not be mixed with other supplies in the same carton.

  (7) Eligible countries for export. The nursing home shall make a good faith effort to determine that shipment of drugs to a selected foreign country is not prohibited. If no evidence of prohibition is found, then shipment may proceed. Documentation of this effort shall be retained for three years from the date of shipment. The nursing home shall contact the following:

    (A) the Office of Foreign Assets Control (OFAC) of the U.S. Department of the Treasury, and the Bureau of Export Administration of the United States Department of Commerce at or (202) 622-1260; or

    (B) any other agency that provides information about the prohibition of certain shipments to foreign countries.

  (8) The nursing home shall prepare a complete and accurate donation record, a copy of which shall be retained by the nursing home for at least three years, containing the following information:

    (A) the name, address, city, country, and telephone number of the licensed practitioner, charitable medical clinic, or foreign recipient receiving the donation;

    (B) documentation of prior consent from the foreign recipient;

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

    (D) the date of the donation.

  (9) All nursing homes who donate drugs to foreign recipients shall comply with the existing statutory standards contained in the 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," and §229.429 of this title (relating to Minimum Standards for Licensure) for "Licensing of Wholesale Distributors of Prescription Drugs--Including Good Manufacturing Practices."

  (10) A nursing home shall notify a foreign recipient to whom donations have been made, if the nursing home 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 §229.23 adopted to be effective May 29, 2003, 28 TexReg 4153; amended to be effective December 9, 2010, 35 TexReg 10755

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