AL Code § 20-3-3 (2021)
2021 Code of Alabama|Title 20 - Food, Drugs and Cosmetics.|Chapter 3 - Donation of Drugs to Charitable Clinics.|Section 20-3-3 - Transfer of Legend Drugs to Charitable Clinic.

Section 20-3-3Transfer of legend drugs to charitable clinic.  (a)(1) Legend drugs, except controlled substances, dispensed to a patient in a hospital, nursing facility, assisted living facility, or specialty care assisted living facility may be donated and transferred pursuant to this section to a charitable clinic to be used by charitable patients free of charge when all of the following conditions are met: a. The drugs are no longer needed by the original patient. b. The drugs have been maintained in accordance with United States Pharmacopoeia and National Formulary storage requirements. c. The drugs were dispensed by unit dose or an individually sealed dose. d. The drugs have not expired. (2) Legend drugs, except controlled substances, dispensed to a patient cared for by a hospice care program may be donated and transferred pursuant to this section to a charitable clinic to be used by charitable patients free of charge when all of the following conditions are met: a. The drugs are no longer needed by the original patient. b. The drugs were dispensed by unit dose or bulk packaging. c. The drugs have not expired. (b) The physician or licensed health care professional of the charitable clinic shall be responsible for determining the suitability of the product for reuse. No product where integrity may not be assured shall be used by the physician at the charitable clinic. A legend drug shall be assigned the expiration date stated on the package. (c) Pursuant to a voluntary agreement between a nursing home, hospital, specialty care assisted living facility, or hospice care program and a charitable clinic, legend drugs may be transferred pursuant to this chapter from the nursing home, hospital, assisted living facility, or specialty care assisted living facility or from the residence of a hospice patient to the charitable clinic if the following procedures are satisfied: (1) The legend drugs shall be physically transferred to a person authorized in writing to pick up the drugs for the charitable clinic. (2) The file of a patient at the nursing home, hospital, assisted living facility, or specialty care assisted living facility or the file of a patient cared for by a hospice care program shall document his or her consent, or in the case of the death of a patient the patient's family's consent, for the donation. (3) The patient's name, prescription number, and any other identifying marks shall be obliterated from the drug container prior to removal from the nursing home, hospital, assisted living facility, or specialty care assisted living facility or the residence of a hospice patient. (4) The name, strength, and expiration date of the legend drug shall remain on the medication package label. (5) An inventory list of the legend drugs shall accompany the drugs being transferred, which list, at a minimum, shall contain for each drug the medication name, strength, expiration date, and quantity. (6) Within one week after an inventoried list of legend drugs is made available, the drugs shall be picked up by a charitable clinic or the drugs shall be destroyed. (d) A licensed nursing home, hospital, specialty care assisted living facility, assisted living facility, or hospice care program, or an owner, operator, employee, or agent of a licensee, shall not be liable for civil damages or for any criminal liability as a result of any acts or omissions in transferring any drugs pursuant to this section unless the act or omission was the result of willful misconduct. (e) No pharmaceutical manufacturer shall be liable for any claim or injury arising due to a transfer of any legend drug pursuant to this chapter, including, but not limited to, liability for failure to transfer or communicate product or consumer information or the expiration date regarding the transferred drug. (f) The State Board of Health may make rules and regulations to carry out the provisions and purposes of this section. (g) All legend drugs distributed under the authority of this chapter shall be dispensed to a patient, resident, or other user only on the order of a licensed physician or other legally authorized licensed medical practitioner. (Act 2002-498, p. 1288, §3.)