Current through Register Vol. 35, No. 18, September 24, 2024
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.
