New Mexico
Register / Volume XXXI, Issue 23 / December 15, 2020
This
is an amendment to 16.19.20 NMAC, Sections 1, 3, 10, 42, 44, 46, 47 and 69,
effective 12/15/2020
16.19.20.1 ISSUING AGENCY: [Regulation and Licensing Department -] Board of Pharmacy.
[16.19.20.1
NMAC - Rp 16.19.20.1 NMAC, 6/26/2018; A, 12/15/2020]
16.19.20.3 STATUTORY AUTHORITY:
Section 30-31-11 of the Controlled Substances Act, 30-31-1 through
30-31-42 NMSA 1978, authorizes the board of pharmacy to promulgate regulations
and charge reasonable fees for the registration and control of the manufacture,
distribution and dispensing of controlled substances. Paragraph (2) of Subsection B of
Section 61-11-6 NMSA 1978 authorizes the board to provide by regulation for the
electronic transmission of prescriptions.
[16.19.20.3
NMAC - Rp 16.19.20.3 NMAC, 6/26/2018; A, 12/15/2020]
16.19.20.10 REGISTRATION FEE:
A. The registration fee or renewal fee required by the
Controlled Substances Act shall be [$180.00 for registrants per
triennium. A locum tenens practitioner
may apply for an initial registration which expires no more than one year after
date of issuance, and this registration fee shall be $60.00] as
listed in 16.19.12 NMAC.
B. Research applicants registered as a practitioner shall not be required to register as a scientific
investigator if he is registered as a practitioner. However, this does not exempt him from the
regulations applicable to a scientific investigator.
C. Duplicate license - $10.00
[16.19.20.10
NMAC - Rp 16.19.20.10 NMAC, 6/26/2018; A, 12/15/2020]
16.19.20.42 PRESCRIPTION REQUIREMENTS:
A. All prescriptions for controlled substances shall be dated
as of, and signed on, the day when issued and shall bear the full name and
address of the patient, the drug name, strength, dosage form, quantity
prescribed, directions for use, and the name, address and registration number
of the practitioner. Information on the
prescription may be added or clarified by the pharmacist
after consultation with the practitioner. A practitioner may sign a paper prescription
in the same manner as he would sign a check or legal document (e.g., J.H. Smith
or John H. Smith). Where an oral order
is not permitted, paper prescriptions must be written with ink or indelible
pencil, typewriter, or printed on a computer printer and shall be manually
signed by the practitioner. A
computer-generated prescription that is printed out or faxed
by the practitioner must be manually signed.
B. Electronic prescriptions shall be created and signed using an application that meets
the requirements of Part 1311 of the Code of Federal Regulations. An individual practitioner may sign and
transmit electronic prescriptions for controlled substances [provided the
practitioner] in a manner that meets all of the requirements of Part 1306.08 of the Code
of Federal Regulations.
(1) Effective April 1, 2021 all controlled
substance prescriptions must be electronically
transmitted (“Electronic Prescriptions for Controlled Substances,” EPCS) except:
(a) for patients residing in an intermediate care, skilled
nursing or correctional facility;
(b) for patients enrolled in hospice;
(c) for an animal by a licensed veterinarian;
(d) a prescription dispensed by a federal facility not subject
to state regulation (e.g. department of veteran affairs, indian
health services, military bases);
(e) a
prescription requiring information that makes electronic transmission
impractical, such as complicated or lengthy directions for use or attachments;
or new medications not yet in electronic system;
(f) for compounded prescriptions;
(g) for prescriptions issued during a temporary technical or
electronic failure at the practitioner’s or pharmacy’s location;
(h) for prescriptions issued in an emergency pursuant to federal
law and rules of the board;
(i) for
prescriptions issued in response to a public health emergency where a
non-patient specific prescription would be permitted;
(j) under extenuating circumstance, not inconsistent with
federal law and where the practitioner communicates directly with the
pharmacist. The pharmacist, using
professional judgment, may accept the non-EPCS and is responsible for ensuring
documentation of the circumstance in the prescription record; and that the
prescription is otherwise in compliance with state and federal law and rules.
C. Unless
otherwise specified, a pharmacist who receives a written, oral, or
facsimile
prescription shall not be
required to verify that the prescription is subject to an exemption and may
dispense a prescription drug pursuant to an otherwise valid written, oral, or
facsimile prescription.
D. A prescription that falls under an
exception to the EPCS requirement may be transmitted
to
a pharmacy in one of the following ways:
[B.] (1) A prescription for a schedule II
controlled substance may be transmitted by the practitioner or the
practitioner’s agent to a pharmacy via facsimile equipment, provided the
original written, signed prescription is presented to the pharmacist for review
prior to the actual dispensing of the controlled substance, except as noted in
[Subsections C and D of 16.19.20.41 NMAC and Subsection E of 16.19.20.42
NMAC.] Paragraphs 2, 3 and 4 of this Subsection The original prescription
shall be maintained in accordance with 16.19.20.31 NMAC.
[C.]
(2) A prescription prepared in
accordance with Subsection A of 16.19.20.[41] 42 NMAC written for
a schedule II narcotic substance to be compounded for the direct administration
to a patient by parenteral, intravenous, intramuscular, or subcutaneous
infusion may be transmitted by the practitioner or the practitioner’s agent to
the parenteral products pharmacy by facsimile.
The facsimile serves as the original written prescription for purposes
of this paragraph and it shall be maintained in
accordance with 16.19.20.31 NMAC.
[D.]
(3) A prescription prepared in
accordance with Subsection A of 16.19.20.[41] 42 NMAC written for
a schedule II substance for a resident of a long term care facility may be
transmitted by the practitioner or the practitioner’s agent to the dispensing
pharmacy by facsimile. The facsimile
serves as the original written prescription for purposes of this sub-section
and it shall be maintained in accordance with
16.19.20.31 NMAC.
[E.]
(4) A prescription prepared in
accordance with Subsection A of 16.19.20. [41] 42
NMAC written for a schedule II narcotic substance for a patient enrolled in a
hospice program certified by Medicare under title XVIII or licensed by the
state may be transmitted by the practitioner or the practitioner’s agent to the
dispensing pharmacy by facsimile.
The practitioner or the practitioner’s agent will note on the
prescription that the patient is a hospice patient. The facsimile serves as the original written
prescription for purposes of this sub-section and it shall be
maintained in accordance with 16.19.20.31 NMAC.
[F.] (5) A pharmacist may
dispense directly a controlled substance listed in schedule III [or],
IV, or V which is a prescription drug as determined under the New Mexico
Drug[s], Device and Cosmetic Act, only pursuant to either a
written prescription signed by a practitioner or a facsimile of a written,
signed prescription transmitted by the practitioner or the practitioner’s agent
to the pharmacy or pursuant to an oral prescription made by an individual
practitioner and promptly reduced to written form by the pharmacist containing
all information required for a prescription except the signature of the
practitioner. A telephone order for a new therapy for an
opiate listed in schedule III, IV, or V shall not exceed a 10
day supply, based on the directions for use, unless a written
prescription is on file at this pharmacy from any practitioner for the same
opiate within the past six months. A
telephone order for this new opiate therapy may not be
refilled.
[G.] E. A pharmacy employee shall verify the
identity of the patient or the patient’s representative who is receiving any
prescription for a controlled substance listed in schedule II, III, IV, or V
before it is released.
Acceptable identification means a current state issued driver’s license,
including photo, or other current government issued photo identification of the
person presenting said identification.
The identification type (e.g.
driver’s license, identification card, passport, etc.), number, name imprinted
on that identification, and state must be recorded. Exceptions are, a new controlled substance
prescription filled for a patient known to the pharmacist or pharmacist intern,
whose identification has already been documented in a
manner determined by a written policy developed by the pharmacist-in-charge; a
controlled substance prescription filled for home delivery; or a controlled
substance prescription filled for and delivered to a licensed facility.
[16.19.20.42
NMAC - Rp 16.19.20.42 NMAC, 6/26/2018; A, 12/15/2020]
16.19.20.44 REFILL PROCEDURE: Each refilling of a schedule III, IV or V controlled
substance prescription shall be entered [on the back of the prescription]
in the prescription record, indicating the amount dispensed, if less
than the amount called for on the prescription, the date of refill and the
initials of the pharmacist dispensing the substance.
[16.19.20.44
NMAC - Rp 16.19.20.44 NMAC, 6/26/2018; A, 12/15/2020]
16.19.20.46 PRESCRIPTION - PARTIALLY FILLED:
A. A prescription for a controlled substance in schedule II may be partially filled if:
(1) the total quantity dispensed in all partial fillings does
not exceed the total quantity prescribed;
(2) the partial fill amount is recorded on the written
prescription or in the electronic prescription record; and
(3) the remaining portions shall be filled not later than 30
days after the date on which the prescription is [written] issued.
B. A prescription for
a controlled substance in schedule II initially filled later than 30 days after
the date [written] issued may be partially filled if;
(1) the pharmacist is unable to dispense the total quantity
prescribed;
(2) the partial fill amount is recorded on the written
prescription or in the electronic prescription record;
(3) the remaining portion is filled within 72 hours of the
partial filling; and
(4) the pharmacist notifies the prescribing physician if the
remaining portion cannot be filled within the 72 hour period. No further quantity may be
supplied beyond 72 hours without a new prescription.
C. Partial filling of a prescription for schedule III [or],
IV or V shall be recorded in the same manner as
a refill, providing the total quantity of partial filling does not exceed the
total quantity prescribed and no dispensing occurs after six months from date
of prescription.
D. A prescription for a schedule II controlled substance
written for a patient in a long term care facility
(LTCF) or for a patient with a medical diagnosis documenting a terminal illness
may be filled in partial quantities, to include individual dosage units.
(1) If there is any question whether a patient may be classified as having a terminal illness, the
pharmacist shall contact the practitioner prior to partially filling the
prescription. Both the pharmacist and
the prescribing practitioner have a corresponding responsibility to assure that
the controlled substance is for a terminally ill patient. The pharmacist shall record on the
prescription whether the patient is “terminally ill” or an
“LTCF patient”.
(2) A prescription that is partially filled and does not contain
the notation “terminally ill” or LTCF patient” shall be
deemed to have been filled in violation of this regulation. For each partial filling, the dispensing
pharmacist shall record on the back of the prescription (or on appropriate
record, uniformly maintained, and readily retrievable) the date of the partial
filling, quantity dispensed, remaining quantity authorized to be dispensed and
the identification of the dispensing pharmacist.
(3) The total quantity of schedule II controlled substances
dispensed in all partial fillings shall not exceed the total quantity
prescribed. Schedule II prescriptions,
for patients in a LTCF or patients with a medical diagnosis documenting a
terminal illness, shall be valid for a period not to exceed 60 days from the
issue date unless sooner terminated by the discontinuance of medication.
[16.19.20.46
NMAC - Rp 16.19.20.46 NMAC, 6/26/2018; A, 12/15/2020]
16.19.20.47 EMERGENCY DISPENSING:
A. Emergency dispensing of schedule II controlled
substances. “Emergency situation”
means the prescribing physician determines:
(1) that immediate administration of a controlled substance is
necessary for proper treatment of the intended patient;
(2) that no appropriate alternative treatment is available,
including administration of a drug which is not a controlled substance under
schedule II; and
(3) that it is not reasonably possible for the prescribing
practitioner to provide [a] an electronically prescribed or
written prescription to be presented to the person dispensing the substance
prior to the dispensing.
B. A pharmacy may dispense a schedule II controlled substance
in the above instance only if he receives oral authorization of a practitioner
or authorization via facsimile machine and provided:
(1) the quantity prescribed is limited to the amount needed to
treat the patient during the emergency period;
(2) the pharmacist shall reduce the prescription to a written
form and it contains all information required of a schedule II controlled
substance prescription except the signature of the prescribing practitioner;
(3) the prescribing physician, within seven days after
authorization of the emergency dispensing, shall furnish a written, signed
prescription to the pharmacist. The
signed prescription shall have written on the face “AUTHORIZATION FOR EMERGENCY
DISPENSING” and the date of the oral order or facsimile order;
(4) the signed prescription shall be attached to the oral
emergency prescription order or the facsimile emergency prescription order and
be filed as other schedule II prescriptions.
C. In the event the prescribing physician fails to deliver a
signed written prescription to the pharmacist, within the seven days period,
the pharmacist shall notify the nearest DEA office, and the board of pharmacy.
[16.19.20.47
NMAC - Rp 16.19.20.47 NMAC, 6/26/2018; A, 12/15/2020]
16.19.20.69 SCHEDULE V:
A. Narcotic drugs containing non-narcotic active medicinal
ingredients. Any
compound, mixture, or preparation containing any of the following narcotic
drugs, or their salts calculated as the free anhydrous base or alkaloid, in
limited quantities as set forth below, which shall include one or more
non-narcotic active medicinal ingredients in sufficient proportion to confer
upon the compound, mixture, or preparation valuable medicinal qualities other
than those possessed by narcotic drugs alone.
(1) Not
more than 200 milligrams of codeine per 100 milliliters or per 100 grams.
(2) Not
more than 100 milligrams of dihydrocodeine per 100
milliliters or per 100 grams.
(3) Not
more than 100 milligrams of ethylmorphine per 100
milliliters or per 100 grams.
(4) Not more than two
and five-tenths milligrams of diphenoxylate and not
less than 25 micrograms of atropine sulfate per dosage unit.
(5) Not
more than 100 milligrams of opium per 100 milliliters or per 100 grams.
(6) Not more than five-tenths milligrams of difenoxin
and not less than 25 micrograms of atropine sulfate per dosage unit.
B. Stimulants. Unless specifically exempted or excluded or
unless listed in another schedule, any material, compound, mixture or preparation
which contains any quantity of the following substances having a stimulant
effect on the central nervous system, including its salts, isomers and salts of
isomers.
(1) Pyrovalerone.
(2) Pseudoephedrine
as a drug that includes any compound, mixture, or preparation that contains any
detectable quantity of pseudoephedrine, its salts or its optical isomers, or
salts of its optical isomers.
Pursuant to 30-31-10.C the following substances
are excluded from schedule V controlled substances: pseudoephedrine products in liquid form
including liquid filled gel caps and pseudoephedrine products already
classified as dangerous drugs.
C. Depressants. Unless specifically exempted
or excluded or unless listed in another schedule, any material,
compound, mixture, or preparation which contains any quantity of the following
substances having a depressant effect on the central nervous system, including
its salts:
(1) Lacosamide
[(R)-2acetoamido-N-benzyl-3-methoxy-propionamide]
(2) Pregabalin
[(S)-3-(aminomethyl)-5-methylhexanoic acid]
(3) Ezogabine
[N-[2-amino-4-(4-flurobenzylamino-phenyl]-carbamic
acid ethyl ester]
(4) Brivaracetam
[(5) drug product approved for
marketing by the U.S. Food and Drug Administration and which contains cannabidiol derived from cannabis and no more than 0.1
percent tetrahydrocannabinols.]
[16.19.20.69
NMAC - Rp 16.19.20.69 NMAC, 6/26/2018; A, 12/17/2019;
A, 12/15/2020]