N.M. Admin. Code § 16.19.34.9

Current through Register Vol. 35, No. 23, December 10, 2024

Section 16.19.34.9 - RECORD KEEPING

All clinics and participating practitioners shall provide separate records or forms documenting the receipt and redistribution of all unused prescription drugs and maintain the records for three years.

A. A form to be signed by the donor serving as receipt of the drug verifying the donor voluntarily donating the drug, the donated prescription drug has been properly stored-not stored at temperature extremes nor hazardous conditions and protected from light and humidity, the container has not been tampered with, and the drug has not been adulterated or misbranded. The form shall include at least the following:

(1) date the drug was donated;

(2) name, address and telephone number of donor;

(3) name, strength and quantity of the drug;

(4) manufacturer and lot number (if applicable) of drug;

(5) the expiration date of drug;

(6) name, date and signature of the practitioner or pharmacist who is accepting and inspecting the donated drugs.

B. A form to be signed by the recipient specifying; knowledge that the donor is not a pharmacist and took reasonable care of the donated prescription drug, that the donor is known to the clinic or the participating practitioner and that there is no reason to believe that the donated prescription drug was improperly handled or stored and any person who exercises reasonable care in donating, accepting or redistributing pursuant to this Section 26-1-3.2 NMSA 1978 shall be immune from civil or criminal liability or professional disciplinary action of any kind for any related injury, death or lose, and that the immunity provided by this section shall not decrease or increase the civil or criminal liability of a drug manufacturer, distributors or dispenser that would have existed but for the donation. The form shall include at least the following:

(1) date the recipient received the drug;

(2) name, address and phone number of the recipient;

(3) name, strength and quantity of the drug;

(4) manufacturer and lot number (if applicable) of drug;

(5) the expiration date of drug;

(6) documentation that donated drug was dispensed with applicable forms as deemed by the REMS requirement;

(7) no product where integrity cannot be assured shall be accepted for redistribution.

C. All records and forms required by this rule may be in electronic form.

N.M. Admin. Code § 16.19.34.9

16.19.34.9 NMAC - N, 11-27-11