TITLE 16 OCCUPATIONAL
AND PROFESSIONAL LICENSING
CHAPTER 19 PHARMACISTS
PART 34 PRESCRIPTION
DRUG DONATIONS
16.19.34.1 ISSUING
AGENCY: Regulation and Licensing Department - Board of
Pharmacy.
[16.19.34.1 NMAC - N, 11-27-11]
16.19.34.2 SCOPE: This
section applies to licensed clinics and participating practitioners located
within the state of New Mexico who provide for the donation and redistribution
of previously dispensed prescription drugs that have not been used.
[16.19.34.2 NMAC - N, 11-27-11]
16.19.34.3 STATUTORY
AUTHORITY: Section 26-1-3.2 of the New Mexico Drug, Device and
Cosmetic Act requires the board of pharmacy to promulgate rules establishing
standards and procedures necessary for the safe redistribution of previously
dispensed prescription drugs.
[16.19.34.4 NMAC - N, 11-27-11]
16.19.34.4 DURATION: Permanent.
[16.19.34.4 NMAC - N, 11-27-11]
16.19.34.5 EFFECTIVE
DATE: November 27, 2011, unless a different date is cited at the end of a
section.
[16.19.34.5 NMAC - N, 11-27-11]
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 licensed clinics and
participating practitioners by establishing standards and procedures including
but not limited to accepting, storing, packaging, labeling, inspecting, record
keeping and disposal.
[16.19.34.6 NMAC - N, 11-27-11]
16.19.34.7 DEFINITIONS:
A. “Board” means the New Mexico board of pharmacy.
B. “Clinic” means a facility
licensed pursuant to Section 61-22-14 NMSA 1978 in which one or more licensed
practitioners diagnose and treat patients and in which drugs are stored,
dispensed or administered for the diagnosis and treatment of the facility’s
patients; provided that “clinic” does not include the privately owned practice
of a licensed practitioner or group of licensed practitioners exempt under
Section 61-11-11 NMSA 1978.
C. “Donor” means an individual who
donates an unused prescription drug to a clinic or participating practitioner,
who originally prescribed that prescription drug for their patient, for the
purpose of redistribution of established patients of that clinic or
practitioner.
D. “Eligible drug” means an unused
prescription drug stored in a tamper-evident container, or by a tamper-evident
process preventing unauthorized access, and has an expiration date of six
months or greater listed on the packaging.
No drug shall be re-dispensed more than one time.
E. “Ineligible drug” means any
controlled substances or any prescription drug within the risk evaluation and mitigation
strategies (REMS) requirements as set forth by Section 505-1[21 USC355-1] of
the Food Drug and Cosmetic Act (FD&C Act), with the exception of a medication
guide (MedGuide) as set forth in Title 34, CFR, Subsection 208, patient package
insert (PPI) or a communication plan, without prior board approval.
F. “Participating practitioner” means
a licensed practitioner who is authorized to prescribe drugs, who registers
with the board and is subject to rules promulgated by the board to participate
in the collection of donated drugs prescribed for use by established patients
of that practitioner, and donated for the purpose of redistribution to
established patients of that practitioner.
G. “Prescription drug” for the
purposes of this rule means any drug required by federal or state law or
regulation to be dispensed only by a prescription, including finished dosage
forms and active ingredients subject to Section 503(b) of the Federal Food,
Drug and Cosmetic Act.
H. “Recipient” means an individual
who voluntarily receives donated prescription drugs.
I. “Tamper-evident” means a device
or process that makes unauthorized access to protected pharmaceutical packaging
easily detected.
J. “REMS” means risk evaluation
and mitigation strategy as required by the Food and Drug Administration
Amendments Act of 2007.
[16.19.34.7 NMAC - N, 11-27-11]
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.
[16.19.34.8 NMAC - N, 11-27-11]
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.
[16.19.34.9 NMAC - N, 11-27-11]
16.19.34.10 LIABILITY:
A. Any person who exercises reasonable care in donating, accepting or
redistributing prescription drugs pursuant to this section 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 section 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 section.
D. This section 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 - N, 11-27-11]
16.19.34.11 PARTICIPATING
PRACTITIONERS AND LICENSED CLINICS:
A. Practitioners and licensed clinics must submit the required application
form provided by the board to obtain eligibility for participation.
B. The board may remove at any time
practitioners or any licensed clinics from participating in the reuse of
prescription drug donation should they fail to comply with regulations stated
therein.
C. The board shall maintain and
publish a current listing of participating practitioners and licensed clinics
including names(s) and address.
[16.19.34.11 NMAC - N, 11-27-11]
16.19.34.12 DISPOSAL: Participating
practitioners and licensed clinics may dispose of unused donated prescription
drugs, that were collected but not redistributed, in accordance with state and
federal requirements for disposal of prescription drugs.
[16.19.34.12 NMAC - N, 11-27-11]
16.19.34.13 RECALLS: Participating
practitioners shall monitor FDA recalls, market withdrawals, and safety alerts
and will communicate with recipients if medications they received may be
impacted by this FDA action.
[16.19.34.13 NMAC - N, 11-27-11]
HISTORY OF 16.19.34 NMAC: [RESERVED]