New Mexico
Register / Volume XXX, Issue 23 / December 17, 2019
This is an amendment to 16.19.20 NMAC, Sections
9, 16, 20, 26, 36, 37, 38, 40, 41, 53, 65, 66, and 69, effective 12/17/2019.
Explanatory
paragraph: In 16.19.20.65 NMAC, Subsections
A through C and Subsections E through F were not published as there are no
changes. In 16.19.20.66 NMAC,
Subsections A through C and Subsections E through F were not published as there
are no changes.
16.19.20.9 REGISTRATION AND EXPIRATION DATES:
A. Any
person who is required to be registered and who is not registered may apply for
registration at any time.
B. In
December 1982 all registrant renewal dates will be assigned to one of 12 groups
which shall correspond to the months of the year. Thereafter, any person who first registers
will also be assigned to one of the 12 groups.
C. Expiration
date of the registration of all individuals or businesses within any group will
be the last day of the month designated for that group. Renewal date will be within 30 days of the
date shown on the registration permit and will expire on that date if not
renewed by the registrant.
D. Renewal
applications will be mailed to the physical, mailing, or electronic
address indicated on the application on file or as amended by change of address
supplied by the registrant to the board of pharmacy.
[16.19.20.9
NMAC - Rp 16.19.20.9 NMAC, 6/26/2018; A, 12/17/2019]
16.19.20.16 PROCEDURE SUMMARY, RESEARCH: A scientific investigator or research applicant shall submit
a summary of procedures indicating the nature, extent and duration of such
research. The summary shall also include
the names of individuals engaged in the project (other than those exempt under
the Controlled Substances Act) the name or names of the substances to be used
in the research project, the adequacy of safeguards against diversion of the
controlled substance(s) to be used, source of supply of controlled substance(s)
if applicable, and evidence of FDA and DEA approval and registration if registered
by the federal agencies.
[16.19.20.16
NMAC - Rp 16.19.20.16 NMAC, 6/26/2018; A, 12/17/2019]
16.19.20.20 INVENTORY RECORDS:
A. All
registrants are required to keep inventory and procurement records.
B. All registrants shall comply with the following inventory
requirements: schedule I, II, III, IV
and V initial, annual [inventory], newly controlled
substances, change in pharmacist in charge, and transfer of pharmacy ownership.
C. All registrants shall conduct an initial inventory of all controlled substances on hand on the date they first engage in controlled substances activity. In the event a registrant commences business with no controlled substances on hand, he/she shall record this fact on the initial inventory.
[C] D. The annual inventory date shall be May
1 [for the initial inventory by the registrant] or on the registrant’s
regular general physical inventory date, provided that [date does not vary
by more than six months before or after May 1] the registrant shall notify
the board of pharmacy of the [date on which the annual inventory will be
taken, if different from May 1] set alternate annual inventory date. The actual taking of the inventory should not
vary more than four days [from] before or after the annual
inventory date (May 1 or set alternate date). [The inventory shall document being taken
either as of the opening or as of the close of business activity, the inventory
date and time, and shall be entered on the inventory record.]
[D] E. [Controlled substances added to the Controlled Substances Act
after date of enactment]
On the effective date that a substance is added to any schedule of
controlled substances, which substance was, immediately prior to that date,
not listed on any schedule, every registrant who possesses that substance shall
take an inventory of all stock of the substance on hand and file this record
with the other inventory records as required.
[E]
F. Upon
the change of a pharmacist-in-charge, an inventory of all controlled substances
shall be taken within 72 hours, by the new pharmacist-in-charge. [The inventory shall be taken either as of
the opening or as of the close of business activity on the inventory date, and
such time and date taken shall be entered on the inventory record.]
[F]
G. Upon
transfer of ownership of a pharmacy, an inventory of all controlled substances
shall be taken by the pharmacist-in-charge.
[The inventory shall be taken either as of the opening or as of the
close of business activity on the inventory date, and such time and date taken
shall be entered on the inventory record.]
H. The inventory
shall include:
(1) the
date;
(2) time
taken (i.e., opening or close of business);
(3) drug
name;
(4) the
drug strength;
(5) the
drug form (e.g., tablet, capsule, etc.);
(6) the
number of units or volume;
(7) the
total quantity. A commercial container which has been
opened shall be the exact count or measure of substances listed in schedule I
or schedule II. If the substance is
listed in schedule III, IV or V, he shall make an estimated count or measure of
the contents, unless the container holds more than 1,000 tablets or capsules in
which case the count must be exact;
(8) expired
or unusable controlled substances shall be documented as such, and inventoried.
(9) The
name, address and DEA registration number of the registrant.
(10) The
signature of the person or persons responsible for taking the inventory.
[16.19.20.20
NMAC - Rp 16.19.20.20 NMAC, 6/26/2018; A, 12/17/2019]
16.19.20.26 PROCUREMENT RECORDS: “Order forms” refer to DEA form 222 or its
electronic equivalent required for distribution or procurement of a
schedule I or II controlled substance under the federal act. [Order forms are issued in books of six
forms in triplicate to registrants by requisition from DEA registration branch,
Department of Justice, P.O. Box 28083, Central Station, Washington, DC, 20005.]
[16.19.20.26
NMAC - Rp 16.19.20.26 NMAC, 6/26/2018; A, 12/17/2019]
16.19.20.36 REPORT OF LOSS OR THEFT OF A
CONTROLLED SUBSTANCE:
A. The registered supplier shall be responsible for
reporting in-transit losses of controlled substances by a common carrier or
contract carrier selected by the supplier upon discovery of such loss or
theft. Registrant shall complete DEA
form 106 as required and furnish a copy to the board of pharmacy.
B. A significant loss or theft of a controlled substance
shall be reported in writing to the board of pharmacy and DEA on form 106 as
required by federal regulations. “Significant
loss” includes suspected diversions, in-transit losses or any other unexplained
loss and must be reported to the board of pharmacy within five days of becoming
aware of that loss. [DEA form 106 may
be obtained from the board of pharmacy or DEA.]
[16.19.20.36
NMAC - Rp 16.19.20.36 NMAC, 6/26/2018; A, 12/17/2019]
16.19.20.37 HOSPITALS, INSTITUTIONS AND CLINICS: Disposal of excess or undesirable controlled substances
resulting from extemporaneous amounts of residue or wasted controlled substances. A registrant who needs to dispose of excess
or undesirable controlled substances resulting from injections from ampules or
less than the full ampule or other such circumstances shall [keep a written
memorandum report on the hospital narcotic records and periodically file a
report on DEA form 41 with DEA pursuant to the requirements of the federal DEA
Regulations 1307.21(c)] record in accordance with DEA regulations [e.g.
21 CFR 1304.22(c) or successor regulation], and two persons (at least one who
is a licensed health care professional) shall witness and record disposal. The registrant will have implemented security
controls and procedures that ensure pharmaceutical wastage is not diverted. The disposal method shall render the
substance irretrievable.
[16.19.20.37
NMAC - Rp 16.19.20.37 NMAC, 6/26/2018; A, 12/17/2019]
16.19.20.38 DISPOSITION OF [DAMAGED] UNUSABLE,
OUTDATED OR UNWANTED CONTROLLED SUBSTANCES:
[Any registrant in possession of any controlled substances and
desiring or required to dispose of such substances(s) may contact the regional
director of DEA for authority and instructions to dispose of such substance.]
A. Disposition shall be in
accordance with DEA regulation 21 CFR Part 1317 (or successor regulation).
B. A registrant,
other than a manufacturer, distributor, reverse distributor, importer,
exporter, or narcotic treatment program, in possession of any controlled
substances and desiring or required to dispose of such substances(s) may
contact the Special Agent in Charge of the DEA in the area in which the
registrant is located by submitting one copy of the DEA form 41 listing the
controlled substance(s) which the registrant desires to dispose for authority
and instructions to dispose of such substance (21 CFR 1317.05). The registrant shall keep a written
memorandum report, and use DEA form 41 to record the destruction.
C. Any registrant
in possession of any controlled substances and desiring or required to dispose
of such substances(s) may:
(1) Promptly
deliver that controlled substance to a reverse distributor's registered
location by common or contract carrier pick-up or by reverse distributor
pick-up at the registrant's registered location;
(2) For
the purpose of return or recall, promptly deliver that controlled substance by
common or contract carrier pick-up or pick-up by other registrants at the
registrant's registered location to: the
registered person from whom it was obtained, the registered manufacturer of the
substance, or another registrant authorized by the manufacturer to accept
returns or recalls on the manufacturer's behalf.
D. Records of
disposition shall be maintained in proper form and available for inspection for
at least three years.
[16.19.20.38
NMAC -Rp 16.19.20.38 NMAC, 6/26/2018; A, 12/17/2019]
16.19.20.40 DISTRIBUTION UPON TRANSFER OR
DISCONTINUANCE OF BUSINESS:
A. Upon
transfer of a business from one owner to another, the registrant may dispose of
the controlled substances in his possession as follows:
(1) On
the date of transfer of controlled substances, a complete inventory of all
controlled substances being transferred shall be taken in accordance with [16.19.20.19]
16.19.20.20 NMAC, [board of pharmacy regulations to] Title 21,
Section 1304.11[-1304.14] of the federal DEA regulations (or successor
regulation). This inventory of the
registrant-transferee and a copy of the inventory shall be included in the
records of each person. It shall not be
necessary to file a copy of the inventory with DEA or the board of pharmacy
unless requested by either agency.
Transfer of schedule I or II substances require the use of [order
forms (Form DEA 222c)] DEA Form 222, and transfer of Schedule III – V
substances require the use of invoice.
(2) All
records required to be kept by the registrant-transferor with reference to the
controlled substances being transferred, shall be transferred to the
registrant-transferee. Responsibility
for the accuracy of records prior to the date of transfer remains with the
transferor, but responsibility for custody and maintenance shall be upon the
transferee.
(3) All
schedule I or II substances must be transferred pursuant to order forms
as required by the federal regulations.
A copy of the inventory will constitute a record of receipt for the
purchaser.
B. Upon
discontinuance of business, if there are controlled substances which are not
transferred to another registrant, these substances shall be handled as
unwanted controlled substances under [16.19.20.37] 16.19.20.38
NMAC.
[16.19.20.40
NMAC - Rp 16.19.20.40 NMAC, 6/26/2018; A, 12/17/2019]
16.19.20.41 PRESCRIPTIONS:
A. A
prescription for a controlled substance may be issued for a legitimate medical
purpose by an individual practitioner acting in the usual course of his
professional practice, and who is registered under the Controlled Substances
Act. The responsibility for the proper
prescribing and dispensing of controlled substances is upon the prescribing
practitioner, but a corresponding responsibility rests with the pharmacist who
fills the prescription.
B. A
prescription may not be issued in order for a practitioner to obtain controlled
substances for supplying the practitioner for the purpose of general dispensing
to patients.
C. A
prescription may not be issued for the dispensing of narcotic drugs listed in
any schedule to a narcotic dependent person for the sole purpose of continuing
his dependence upon such drugs, unless all the following conditions are met:
(1) the
narcotic controlled drug is in Schedule III, IV, or V and is approved by the
Food and Drug Administration specifically for use in maintenance or
detoxification treatment; and
(2) the
prescribing practitioner meets all state and federal requirements to prescribe
the narcotic for maintenance or detoxification treatment (e.g. DATA waived
practitioner; 21 CFR 1301.28 or successor regulation).
[D. A
prescription may not be issued for the dispensing of the narcotic drugs listed
in any schedule to a narcotic drug-dependent person in the course of conducting
an authorized clinical investigation in the development of a narcotic addict
rehabilitation program.]
[16.19.20.41
NMAC - Rp 16.19.20.41 NMAC, 6/26/2018; A 12/17/2019]
16.19.20.53 DISPENSING WITHOUT PRESCRIPTION:
A. A controlled substance listed in
schedule V and a substance listed in schedules II, III, or IV which
is not a prescription drug as determined by FDA and the Drug and
Cosmetic Act, may be dispensed by a pharmacist without a prescription provided:
(1) such dispensing is made by a
pharmacist or registered pharmacist intern and not by a non-pharmacist
employee;
(2) not more than eight ounces of any
controlled substance containing opium, nor more than 48-dosage units is
dispensed at retail to the same person in any given 48-hour period;
(3) not more than four ounces of any
other controlled substance or more than 24-dosage units may be dispensed at
retail to the same person in any given 48-hour period;
(4) the
purchaser is at least 18 years of age;
(5) the pharmacist requires every
purchaser of such substance, not known to him to furnish suitable
identification (including proof of age where appropriate);
(6) a bound record book for dispensing
such substances is maintained requiring the signature and address of the
purchaser, the name and quantity of the controlled substance purchased, the
date of each purchase and the name or initials of the pharmacist who dispensed
the substance; the book shall contain a statement on each page where purchaser
is required to sign, stating no purpose of such substance has been made within
the given 48-hour period at another pharmacy and the purchaser shall be made
aware of such statement before signing the record.
B. Exempt
pseudoephedrine product.
(1) Any
pseudoephedrine containing product listed as a schedule V controlled substance in
Paragraph (2) of Subsection B of 16.19.20.69 NMAC shall be dispensed, sold or
distributed only by a licensed pharmacist, pharmacist intern, or a registered
pharmacy technician.
(2) Unless
pursuant to a valid prescription, a person purchasing, receiving or otherwise
acquiring the compound, mixture or preparation shall:
(a) produce
a driver’s license or other government-issued photo identification showing the
date of birth of the persons;
(b) sign
a log after reading the purchaser statement for pseudoephedrine receipt or
other program or mechanism indicating the date and time of the transaction,
name of the person, address, driver’s license number or government issued
identification number, name of the pharmacist, pharmacist intern or pharmacy
technician conducting the transaction, the product sold and the total quantity,
in grams or milligrams, of pseudoephedrine purchased; this log will be only for
exempt pseudoephedrine products and shall be kept separate from all other
records; the log is to be produced in a way that a customer’s personal
information is not available to other purchasers;
(c) be
limited to no more than three and six-tenths grams per day or more than a total
of nine grams of a product, mixture or preparation containing pseudoephedrine
within a [thirty] 30-day period.
(3) Pseudoephedrine
purchaser statement must state in addition to any federal requirements: “I have
not purchased more than three and six-tenths grams today or more than a total
of nine grams of pseudoephedrine as a single entity or in a combination with
other medications in the last 30 days.
Entering false statements or misrepresentations in this logbook may
subject me to criminal penalties.”
(4) Prices
charged for compounds, mixtures, and preparations that contain pseudoephedrine
shall be monitored. The board may adopt
rules to prevent unwarranted price increases as a result of compliance with
this section.
(5) Pharmacies
shall submit the information collected pursuant to Paragraph (2) of Subsection
B of 16.19.20.53 NMAC electronically, in a board defined format, to the board
or its agents. Pharmacies will submit
data every seven days beginning September 15, 2013. Pharmacies may petition the executive
director of the board for an alternative method for the submission of the
information collected pursuant to this section.
(6) Authority
to contract: The board is authorized to
contract with another agency of this state or with a private vendor, as
necessary, for the collection of the information collected pursuant to
Paragraph (2) of Subsection B of 16.19.20.53 NMAC. Any contract shall be bound to comply with
the provisions regarding confidentiality of prescription or personal
information in 16.19.20.53 NMAC of this regulation and shall be subject to the
penalties specified in 16.19.20 NMAC and 16.19.27 NMAC.
[16.19.20.53 NMAC - Rp 16.19.20.53 NMAC, 6/26/2018; A, 12/17/2019]
16.19.20.65 SCHEDULE I:
***
D. DEPRESSANTS: Unless specifically exempt
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, isomers
and salts of isomers whenever the existence of such salts, isomers and salts of
isomers is possible within the specific chemical designation:
(1) Mecloqualone;
(2) Methaqualone;
(3) Benzodiazepines;
(a) Bromazepam;
(b) Camazepam;
(c) Cloxazolam;
(d) Delorazepam;
(e) Ethylloflazepate;
(f) Fudiazepam;
(g) Flunitrazepam;
(h) Haloxazolam;
(i) Ketazolam;
(j) Loprazolam;
(k) Lormetazepam;
(l) Medazepam;
(m) Nimetazepam;
(n) Nitrazepam;
(o) Nordiazepam;
(p) Oxazolam;
(q) Phenazepam
[(q)]
(r) Pinazepam;
[(r)]
(s) Tetrazepam;
[(s)] (t) Flubromazepan;
[(t)]
(u) Diclazepam
(4) Gamma hydroxybutyric acid and any chemical compound that is
metabolically converted to GHB;
(5) Gamma butyrolactone and any chemical compound that is
metabolically converted to GHB;
(6) 1-4 butane diol and any chemical compound that is
metabolically converted to GHB
(7) GHV
or 4-methyl-GHB; γ-hydroxyvaleric acid;
(8) GVL; γ-valerolactone;
(9) MMQ; methylmethaqualone;
(10) MBQ; mebroqualone.
***
[16.19.20.65
NMAC - Rp 16.19.20.65 NMAC, 6/26/2018; A, 12/17/2019]
16.19.20.66 SCHEDULE II:
***
D. DEPRESSANTS: Unless specifically exempt or unless listed
in another schedule any material, compound mixture or preparation which
contains any quantity of the substance having a depressant effect on the
central nervous system, including its salts, isomers and salts of isomers is
possible within the specific chemical designation.
(1) Amobarbital;
(2) Secobarbital;
(3) Pentobarbital;
(4) Phencyclidine;
(5) Glutethimide;
(6) 1-phenylcyclohexylamine;
(7) 1-piperidinocyclohexanecarbonitrile.
(8) Dronabinol in an oral solution in a drug product approved for
marketing by the U.S. Food and Drug Administration.
***
[16.19.20.66
NMAC - Rp 16.19.20.66 NMAC, 6/26/2018; A, 12/17/2019]
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]