N.M. Admin. Code § 16.19.34.8

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

Section 16.19.34.8 - PROCEDURES

All clinics and participating practitioners shall follow the procedures for accepting and redistributing certain donated prescription drugs, including refrigerated drugs, consistent with public health and safety standards.

A. Before accepting donated prescription drugs the clinic or the participating practitioner shall:

(1) register with the New Mexico board of pharmacy as a practitioner who will facilitate prescription drug donation;

(2) provide donor with appropriate form for documentation and verification upon acceptance of an eligible donated drug;

(3) identify drug as eligible or ineligible prior to accepting the donated drug;

(a) ineligible drugs may not be accepted for donation;

(b) only drugs originally prescribed by a licensed clinic or practitioner may be accepted.

B. Standards and procedures for storing donated prescription drugs.

(1) Donated prescription drugs must be stored in compliance with the manufacturer's storage requirements per the drug monograph.

(2) All donated drugs must be stored in compliance with the manufacturer's storage requirements per the drug monograph.

C. Standards and procedures for labeling donated prescription drugs:

(1) all personal information from the donor must be removed from packaging;

(2) labeling donated prescription drugs must be in compliance with the food and drug administration (FDA) and the state of New Mexico's requirements for labeling prescription drugs.

D. Before redistributing donated prescription drugs the clinic or the participating practitioner shall.

(1) Comply with all applicable federal laws and the laws of the state that deal with the inspection, storage, labeling and redistribution of donated prescription drugs.

(2) Confirm that the donor of a prescription drug is or was a patient of that practitioner or clinic.

(3) Examine the donated prescription drug to determine that it has not been adulterated or misbranded and certify that the drug has been stored in compliance with the requirements of the product.

(4) Have the donor read and sign the board approved donor form, this form will serve as documentation and verification upon acceptance of eligible donated drugs.

(5) Have all recipients of donated prescription drugs read and sign the board approved recipient form.

(6) Confirm the patient receiving the donated prescription drug has a valid prescription/order for the drug.

(7) Provide the recipient of any prescription drug with a REMS's required patient-directed instructional document accompanying the medication, which could be either a MedGuide or a PPI.

(8) Confirm they have received and read the formal communication plan from the drug manufacturer as part of the REMS requirement for that prescription drug if applicable.

E. Standards and procedures for inspecting donated prescription drugs to determine that the packaging is tamper-evident and that the donated prescription drugs are unadulterated, within the labeled expiration date, and are safe and suitable for distribution.

(1) When inspecting packaging ensure:

(a) tamper-resistant packaging is intact;

(b) there are no breaks, cracks or holes in packaging;

(c) appropriate quantity as indicated on package;

(d) consistency of information is maintained on packaging, expiration date, lot number and outer packaging is applicable.

(2) When inspecting liquids observe:

(a) color;

(b) thickness;

(c) unusual particles;

(d) transparency;

(e) odor.

(3) When inspecting tablets or capsules observe and confirm uniformity of:

(a) color;

(b) shape;

(c) unusual spots;

(d) texture;

(e) odor;

(f) imprint or markings;

(g) physical damage, cracks, breaks, erosion, abrasion.

F. A handling fee not to exceed twenty dollars ($20.00) may be charged to the recipient by the clinic or the participating practitioner to cover the costs of inspecting, storing, labeling and redistributing the donated prescription drug.

N.M. Admin. Code § 16.19.34.8

16.19.34.8 NMAC - N, 11-27-11