New Mexico
Register / Volume XXXVII, Issue 3 / February 10, 2026
TITLE 16 OCCUPATIONAL
AND PROFESSIONAL LICENSING
CHAPTER 19 PHARMACISTS
PART 34 PRESCRIPTION
DRUG DONATIONS
16.19.34.1 ISSUING
AGENCY: Board of Pharmacy.
[16.19.34.1 NMAC - Rp,
16.19.34.1, 2/10/2026]
16.19.34.2 SCOPE: This
section applies to eligible recipients involved in the donation and
redistribution of unused prescription drugs.
[16.19.34.2 NMAC - Rp,
16.19.34.2, 2/10/2026]
16.19.34.3 STATUTORY
AUTHORITY: Section
26-1-3.2 of the New Mexico Drug, Device and Cosmetic Act mandates the Board of
Pharmacy to establish rules for the safe redistribution of unused prescription
drugs.
[16.19.34.4 NMAC - Rp, 16.19.34.3, 2/10/2026]
16.19.34.4 DURATION: Permanent.
[16.19.34.4 NMAC - Rp, 16.19.34.4, 2/10/2026]
16.19.34.5 EFFECTIVE
DATE: February
10, 2026, unless a different date is cited at the end of a section.
[16.19.34.5 NMAC - Rp,
16.19.34.5, 2/10/2026]
16.19.34.6 OBJECTIVE: The
objective of Part 34 of Chapter 19 is to ensure the safe donation and
redistribution of unused prescription drugs by establishing standards and
procedures for accepting, storing, packaging, labeling, inspecting, record
keeping and disposal.
[16.19.34.6 NMAC - Rp,
16.19.34.6, 2/10/2026]
16.19.34.7 DEFINITIONS:
A. “Board” means the New Mexico board of pharmacy.
B. “Donor” means a person, including
persons from other states, who donates unused prescription drugs to an eligible
recipient for the purpose of redistribution to patients.
C. “Eligible drug” means an unused,
unexpired prescription drug stored in a tamper-evident container, or by a
tamper-evident process preventing unauthorized access, that the eligible
recipient has inspected and has no reason to believe was improperly handled,
stored, adulterated or is unsuitable for redistribution.
D. “Eligible recipient” means a person who registers with the
board to participate in the collection of donated drugs and is:
(1) licensed
pursuant to Section 61-11-14 NMSA 1978 to receive and distribute prescription
drugs;
(2) a health care facility licensed by the health care
authority pursuant to the Health Care Code Section 24A NMSA 1978; or
(3) a practitioner licensed in New Mexico to prescribe
prescription drugs.
E. “Ineligible drug” means
controlled substances, or any prescription medication that is subject to a Risk
Evaluation and Mitigation Strategy (REMS) under Section 505-1, 21 USC 355-1 of
the Federal Food Drug and Cosmetic Act unless in compliance with all applicable
REMS requirements, including being accompanied by a MedGuide (as set forth in
Title 34 CFR, Subsection 208), or patient package insert (PPI).
F. “Patient” means an individual
who voluntarily receives donated prescription drugs.
G. “Prescription drug” means any
drug required by federal or state law to be dispensed only by a prescription,
including Food and Drug Administration (FDA)-approved drugs labeled for
investigational use.
H. “Tamper-evident” means a device
or process that makes unauthorized access to protected pharmaceutical packaging
easily detected.
I. “REMS” means Risk Evaluation and
Mitigation Strategy.
[16.19.34.7 NMAC - Rp,
16.19.34.7, 2/10/2026]
16.19.34.8 PROCEDURES: Eligible
recipients must adhere to procedures for accepting and redistributing donated
prescription drugs, including refrigerated drugs, consistent with public health
and safety standards. Any person,
including persons from other states, may donate unexpired and unused
prescription drugs to an eligible recipient, and an eligible recipient may
accept and redistribute the donated prescription drugs in accordance with board
rules. An eligible recipient may
dispense or administer prescription drugs to a patient only if otherwise
permitted by law. Donated prescription
drugs shall only be redistributed to a patient if the drugs will not expire
before the patient is able to completely use the drugs, based on the directions
for use given by the patient's prescribing health care professional
A. Before accepting donated
prescription drugs the eligible recipient shall:
(1) register with the board as an eligible recipient;
(2) identify drug as eligible or ineligible prior to accepting the donated
drug into inventory;
(a) ineligible drugs may not be accepted for donation;
(b) single unit doses that consist of two or more
separately manufactured drug products may not be separated and repackaged. This
restriction does not apply to finished, manufactured combination drug products
that contain multiple active ingredients in a single dosage form;
(c) drugs packed in single unit doses may be
accepted and redistributed when the outside packaging is opened if the single
unit dose packaging is undisturbed;
(d) specialty medication delivered to a facility
or practitioner that cannot administer or distribute to the patient originally
dispensed for may be donated and redistributed if the medication was stored
properly and kept under restricted access to prevent tampering or adulteration.
B. Storage: Comply with
the manufacturer’s storage requirements per the drug monograph.
C. Labeling prior to redistribution:
(1) Remove previous patient information.
(2) Comply with FDA and state labeling requirements.
D. Redistribution:
(1) Comply with all applicable federal and state laws that deal with the
inspection, storage, labeling and redistribution of donated prescription drugs.
(2) 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.
(3) Have all patients receiving donated prescription drugs read and
electronically or physically sign the patient form.
(4) Prescription or order required:
(a) A
prescription is required for an eligible recipient pharmacy to dispense donated
prescription drug to a patient.
(b) A practitioner may redistribute donated prescription drug to their own
patient pursuant to a valid patient-practitioner relationship with records
maintained consistent with the standard of care and as required by this Part.
(5) Comply with all applicable REMS requirements, including:
(a) registration
and reporting;
(b) provide patient with MedGuide or PPI
E. Inspection: Determine
that the donated prescription drugs are in tamper-evident packaging,
unadulterated, unexpired, and safe and suitable for redistribution.
(1) When inspecting packaging ensure:
(a) tamper-evident packaging is intact;
(b) there are no breaks, cracks or holes in packaging;
(c) consistency of information, such as expiration date and lot number on
inner and outer packaging, if applicable.
(2) When inspecting liquids observe, if possible, without removing tamper
evident primary container seal:
(a) color;
(b) thickness;
(c) unusual particles;
(d) transparency;
(e) odor.
(3) When inspecting tablets or capsules observe and confirm uniformity, if
possible, without removing tamper evident primary container seal:
(a) color;
(b) shape;
(c) unusual spots;
(d) texture;
(e) odor;
(f) imprint or markings;
(g) physical damage, cracks, breaks, erosion, abrasion.
F. Payment, handling fee: A
handling fee not to exceed the reasonable costs of participating in the
collection of donated prescription drugs may be charged to the patient by the
eligible recipient to cover the costs of inspecting, storing, labeling and
redistributing the donated prescription drug.
Prescription drugs donated under this Part shall not be resold, and
donors may be reimbursed only for reasonable, donation-related costs, including
shipping and logistics.
G. Interstate
Participation: A properly licensed
eligible recipient pharmacy operating in another state may participate in the
activities described under this Part and may dispense donated drugs to patients
in this state in compliance with state and federal laws, unless compliance
would violate the laws of the resident state.
H. Transfer
and Repackaging: Notwithstanding any
other law or rule, an eligible recipient pharmacy may:
(1) Transfer donated prescription drugs to another eligible recipient
pharmacy. The receiving pharmacy must
maintain records of the transfer. Any
subsequent transfer of a donated prescription drug must include pedigree
records tracing to the original eligible recipient. The transferring pharmacy may assess a
handling fee not to exceed the reasonable costs of transferring the drug.
(2) Repackage donated prescription drugs as necessary for storage,
dispensing, administration, or transfers in accordance with this Part.
(3) Repackaged
prescription drugs shall be labeled with the drug name, strength, and
expiration date. If multiple packaged
donated prescription drugs with varied expiration dates are repackaged together
for dispensing, the shortest expiration date shall be used.
I. An
eligible recipient that engages in sales or other monetary transactions for
prescription drugs shall keep donated drug inventory in a manner that
distinguishes them physically or electronically from non-donated inventory.
J. The
donation, transfer, receipt or facilitation of donation, transfer, and receipt
of prescription drugs under this Part is not wholesale distribution and shall
not require a wholesale distributor license.
[16.19.34.8 NMAC - Rp,
16.19.34.8, 2/10/2026]
16.19.34.9 RECORD
KEEPING: Eligible recipients shall maintain records of
receipt and redistribution for three years.
A. Receipt Records:
(1) donor verification that the prescription drug is voluntarily donated, was
properly stored, the container has not been opened or tampered with, and the
drug has not been adulterated or misbranded;
(2) date of donation;
(3) name, address and telephone number of donor;
(4) name, strength and quantity of the drug;
(5) drug manufacturer;
(6) drug expiration
date;
B. Redistribution Records, Patient Form:
(1) Prior to the initial dispensing of a donated
prescription drug, a patient will electronically or physically sign a form that
specifies:
(a) knowledge that the donor took reasonable care of the donated
prescription drug;
(b) knowledge that the donated prescription drug has been inspected and there is no
reason to believe that the donated prescription drug was improperly handled or
stored;
(c) that any person who exercises reasonable care in donating, accepting or
redistributing pursuant to 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 loss;
(d) that the immunity provided by Section 26-1-3.2 NMSA 1978 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;
(2) Patients receiving donated prescription drugs from an eligible
recipient that predominantly dispenses donated prescription drugs shall be
required to sign the form only at their initial dispense.
C. Custodial
care facility, licensed facility or clinic as donor:
(1) A custodial care facility or licensed facility as defined in 16.19.11.7
NMAC, or clinic as defined in 16.19.10.7 NMAC that engages in donation shall
maintain records that include:
(a) date of donation;
(b) entity the drug was donated to;
(c) patient name, as applicable;
(d) drug name, strength, dosage form, and quantity;
(e) date dispensed, as applicable;
(f) prescription number, as applicable;
(g) dispensing
pharmacy name, as applicable
(2) This record will be maintained for three years.
(3) The consultant pharmacist will be responsible for donation oversight.
D. A
donor or eligible recipient may contract with one another or a third-party to
create or maintain records on each other’s behalf. An identifier, such as a serial number or
barcode, may be used in place of any or all information required by a record or
label under this section if it allows for such information to be readily
retrievable. Upon request by a state or
federal regulator the identifier used for requested records shall be replaced
with the original information. An
identifier shall not be used on patient labels when dispensing or administering
a drug.
E. All records and forms required by
this Section may be in electronic form.
F. All records required under this part will be available for inspection by
the Board.
[16.19.34.9 NMAC - Rp,
16.19.34.9, 2/10/2026]
16.19.34.10 LIABILITY:
A. Any person who exercises reasonable care in donating, accepting or
redistributing prescription drugs pursuant to this Part shall be immune from
civil or criminal liability or professional disciplinary action of any kind for
any related injury, death or loss.
B. The immunity provided by this Part shall not decrease or increase the
civil or criminal liability of a drug manufacturer, distributor or dispenser
that would have existed but for the donation.
C. A manufacturer shall not be
liable for failure to transfer or communicate product consumer information or
the expiration date of the donated prescription drug pursuant to this Part.
D. This Part does not restrict the
authority of an appropriate government agency to regulate or ban the use of any
prescription drugs.
[16.19.34.10 NMAC - Rp,
16.19.34.10, 2/10/2026]
16.19.34.11 ELIGIBLE
RECIPIENTS:
A. Eligible recipients must submit the required application provided by
the board to obtain eligibility for participation.
B. The board may remove at any time
eligible recipients from participating in prescription drug donation activities
should they fail to comply with this Part.
C. The board shall maintain and
publish a current listing of eligible recipients – the board’s online license
lookup function shall fulfill this requirement.
[16.19.34.11 NMAC - Rp,
16.19.34.11, 2/10/2026]
16.19.34.12 DISPOSAL: Eligible
recipients may dispose of unused donated prescription drugs, that were not
redistributed, in accordance with state and federal requirements. A record of
such disposed prescription drugs shall consist of the disposal method, the date
of disposal, and the name, strength, and quantity of each drug disposed.
[16.19.34.12 NMAC - Rp,
16.19.34.12, 2/10/2026]
16.19.34.13 RECALLS: Eligible
recipients shall monitor FDA recalls, market withdrawals, and safety alerts and
will communicate with patients if medications they received may be impacted by
this FDA action. Prescription drugs
listed in a recall notice are considered recalled unless an affixed lot number
demonstrates they are excluded.
[16.19.34.13 NMAC - Rp,
16.19.34.13, 2/10/2026]
HISTORY OF 16.19.34 NMAC:
History of Repealed
Material: 16.19.34 NMAC, Prescription Drug Donations
filed 11/27/2011, was repealed and replaced, effective 2/10/2026.