New
Mexico Register / Volume XXIX, Issue 12 / June 26, 2018
TITLE
16 OCCUPATIONAL AND
PROFESSIONAL LICENSING
CHAPTER
19 PHARMACISTS
PART
20 CONTROLLED SUBSTANCES
16.19.20.1 ISSUING AGENCY: Regulation and Licensing
Department - Board of Pharmacy.
[16.19.20.1
NMAC - Rp 16 19.20.1 NMAC, 06-26-2018]
16.19.20.2 SCOPE: All persons or entities that manufacture,
distribute, dispense, administer, prescribe, deliver, analyze, or conduct
research using controlled substances.
[16.19.20.2
NMAC - Rp 16 19.20.2 NMAC, 06-26-2018]
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.
[16.19.20.3
NMAC - Rp 16 19.20.3 NMAC, 06-26-2018]
16.19.20.4 DURATION: Permanent.
[16.19.20.4
NMAC - Rp 16.19.20.4 NMAC, 06-26-2018]
16.19.20.5 EFFECTIVE DATE: June 26, 2018, unless a different date is
cited at the end of a section.
[16.19.20.5
NMAC - Rp 16 19.20.5 NMAC, 06-26-2018]
16.19.20.6 OBJECTIVE: The objective of Part 20 of Chapter 19 is to
protect the public health and welfare of the citizens of New Mexico by controlling
and monitoring access to controlled substances and to give notice of the
board’s designation of particular substances as controlled substances.
[16.19.20.6
NMAC - Rp 16 19.20.6 NMAC, 06-26-2018]
16.19.20.7 DEFINITIONS: [RESERVED]
[16.19.20.7
NMAC - Rp 16 19.20.7 NMAC, 06-26-2018]
16.19.20.8 REGISTRATION REQUIREMENTS: Persons required to register:
A. manufacture - term includes repackagers;
B. distributors - term includes wholesale drug distributors;
C. dispensers - pharmacies, hospital pharmacies, clinics (both
health and veterinarian);
D. practitioners - includes a physician, doctor of oriental medicine, dentist, physician assistant,
certified nurse practitioner, clinical nurse specialist, certified nurse-midwife,
veterinarian, pharmacist, pharmacist clinician, certified registered nurse
anesthetists, psychologists, chiropractic examiner, euthanasia technicians or
other person licensed or certified to prescribe and administer drugs that are
subject to the Controlled Substances Act. Practitioners,
excluding veterinarians, must register with the New Mexico prescription
monitoring program in conjunction with their controlled substance registration.
E. scientific investigators or researchers;
F. analytical laboratories and chemical analysis laboratories;
G. teaching institutes;
H. special projects and demonstrations which bear directly on
misuse or abuse of controlled substances - may include public agencies,
institutions of higher education and private organizations;
I. registration waiver:
an individual licensed practitioner (e.g., intern, resident, staff
physician, mid-level practitioner) who is an agent or employee of a hospital or
clinic, licensed by the board, may, when acting in the usual course of
employment or business, order controlled substances, for administration to the
patients of the facility, under controlled substance registration of the
hospital or clinic in which he or she is employed provided that:
(1) the
ordering of controlled substances for administration, to the patients of the
hospital or clinic, is in the usual course of professional practice and the
hospital or clinic authorizes the practitioner to order controlled substances
for the administration to its patients under its state controlled substance
registration;
(2) the
hospital or clinic has verified with the practitioner's licensing board that
the practitioner is permitted to order controlled substances within the state;
(3) the
practitioner acts only within their scope of employment in that hospital or
clinic;
(4) the
hospital or clinic maintains a current list of practitioners given such
authorization and includes the practitioner's full name, date of birth,
professional classification and license number, and home and business addresses
and phone numbers;
(5) the
list is available at all times to board inspectors, the DEA, law enforcement
and health professional licensing boards; and
(6) the
hospital or clinic shall submit a current list of authorized practitioners with
each hospital or clinic controlled substance renewal application.
[16.19.20.8
NMAC - Rp 16 19.20.8 NMAC, 06-26-2018]
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 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, 06-26-2018]
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.
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, 06-26-2018]
16.19.20.11 APPLICATION FORMS: Application forms may be obtained
from the board of pharmacy, Albuquerque, New Mexico.
[16.19.20.11
NMAC - Rp 16 19.20.11 NMAC, 06-26-2018]
16.19.20.12 SCHEDULES: Applications shall designate the schedule of controlled
substances and whether the application is for narcotic or non-narcotic in
schedules I through V.
[16.19.20.12
NMAC - Rp 16 19.20.12 NMAC, 06-26-2018]
16.19.20.13 SEPARATE REGISTRATION OF EACH
PRINCIPAL PLACE OF BUSINESS:
Separate
registration is required for each principal place of business or professional
practice with the address indicated on the application if drugs are dispensed
or distributed from the different locations.
NOTE: This does not
include warehouse storage areas; office used by agents for soliciting which
contain no controlled substances other than samples, physician’s office where
controlled substances are prescribed but not administered or otherwise
dispensed.
[16.19.20.13
NMAC - Rp 16 19.20.13 NMAC, 06-26-2018]
16.19.20.14 INFORMATION REQUIRED:
A. The board shall register an applicant to manufacture or
distribute controlled substances unless it determines that the issuance of that
registration would be inconsistent with the public interest. In determining the public interest, the board
may consider the following factors from information listed on the application:
(1) maintenance
of effective controls against diversion of controlled substances;
(2) compliance with
applicable state and local law;
(3) any convictions of
the applicant under any federal or state laws relating to any controlled
substance;
(4) past experience in
the manufacture or distribution of controlled substances, and the existence in
the applicant’s establishment of effective controls against diversion;
(5) furnishing by the
applicant of false or fraudulent material in any application filed under the
Controlled Substances Act;
(6) suspension or
revocation of the applicant’s federal registration to manufacture, distribute
or dispense controlled substances as authorized by federal law; and
(7) any other factors
relevant to and consistent with the public health and safety.
B. Each application shall include all information as required
on the application form, including but not limited to a current DEA
registration and professional license, and shall be signed by the applicant.
[16.19.20.14
NMAC - Rp 16 19.20.14 NMAC, 06-26-2018]
16.19.20.15 FACILITY INSPECTION: The board of pharmacy may direct
the drug inspector to inspect the facilities prior to approval of any
application for security provision and other applicable standards as required
by the Controlled Substances Act.
[16.19.20.15
NMAC - Rp 16 19.20.15 NMAC, 06-26-2018]
16.19.20.16 PROCEDURE SUMMARY: 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, 06-26-2018]
16.19.20.17 ANALYTICAL LABORATORIES:
A. Analytical laboratory applicants shall submit application on
the form provided by the board. All applicable
questions on the application shall be filled in and signed by the person in
charge of the facility.
B. Quantities of controlled substances in possession of
analytical laboratories shall be limited to such quantities as required for
reference standards, assays or other scientific purposes.
[16.19.20.17
NMAC - Rp 16 19.20.17 NMAC, 06-26-2018]
16.19.20.18 EXEMPTION OF LAW ENFORCEMENT
OFFICIALS: Registration is
waived for the following persons:
A. Any officer or employee of the state or federal customs
agency, the state police, or any enforcement officer of any political
subdivision of the state, who is engaged in the enforcement of any federal,
state and local law relating to controlled substances and is duly authorized to
possess controlled substances in the course of his official duties.
B. Any official exempted by this section may procure any
controlled substance in the course of an inspection pursuant to Section 31 of
the Controlled Substances Act or in the course of any criminal investigation
involving the person from whom the substance was procured.
C. Laboratory personnel, when acting in the scope of their
official duties, are also exempt from registration under the Controlled
Substances Act.
[16.19.20.18
NMAC - Rp 16 19.20.18 NMAC, 06-26-2018]
16.19.20.19 MODIFICATION, TRANSFER AND TERMINATION
OF REGISTRATION:
A. Modification of a registration to authorize
additional controlled substances may be made by filing an application in the
same number as an application for a new registration. No fee shall be required for such
modification.
B. Registration shall terminate if and when a registrant dies,
discontinues business or professional practice, has his professional license
revoked or suspended, no longer possesses a DEA registration or has had his DEA
registration revoked or suspended, or changes his name or address as shown on
the registration. In such instances, the
registrant or his estate shall notify the board of pharmacy promptly of such
fact and return certificate of registration to the board within 30 days.
C. Inventories and records of controlled substances listed in
schedules II, III, IV and V shall be maintained either separately from all
other records or in such form that the information required is readily
retrievable from ordinary business records of the registrant.
D. In the event of a change in name or address the person shall
file an application in the same number as an application for modification of a
registration. No fee shall be required
for such modification.
E. Registration under the Controlled Substances Act shall not
be transferable.
[16.19.20.19
NMAC - Rp 16 19.20.19 NMAC, 06-26-2018]
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 annual inventory
C. 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. The actual taking of the inventory should not
vary more than four days from the annual inventory 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. Controlled substances added to the Controlled Substances Act
after date of enactment, 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. 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. 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.
[16.19.20.20
NMAC - Rp 16 19.20.20 NMAC, 06-26-2018]
16.19.20.21 INVENTORY RECORDS OF MANUFACTURERS AND
REPACKAGERS: Manufacturers and
repackagers inventory records shall contain the following information:
A. Finished form:
(1) name of substance;
(2) each finished form of the substance
(10 milligram tablet, etc.)
(3) the number of units or volume of each
finished form in each commercial container (100 tablet bottle, etc.)
(4) the number of commercial containers
of each such finished form.
B. Controlled substances not included above such as damaged,
defective impure substances awaiting a disposal giving total quantity and the
name of the substance. A statement of
reason for the substance being included in this category.
[16.19.20.21
NMAC - Rp 16 19.20.21 NMAC, 06-26-2018]
16.19.20.22 DISTRIBUTION INVENTORY RECORDS: Distributor inventory records
shall contain the same information required of manufacturers.
[16.19.20.22
NMAC - Rp 16 19.20.22 NMAC, 06-26-2018]
16.19.20.23 INVENTORY REQUIREMENTS - RESEARCH:
A. Research registrant shall include in his inventory the name
of the substance, each finished form of the substance, the number of units or
volume of each finished form in each commercial container (100 tablet bottle, etc.)
and the number of commercial containers of each such finished form.
B. 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.
[16.19.20.23
NMAC - Rp 16 19.20.23 NMAC, 06-26-2018]
16.19.20.24 ANALYTICAL LABORATORIES: Analytical laboratories shall
include in the inventory record the same information required of
manufacturer’s.
[16.19.20.24
NMAC - Rp 16 19.20.24 NMAC, 06-26-2018]
16.19.20.25 CONTROLLED SUBSTANCES INVENTORIES AND
RECORDS:
A. Pharmacies, hospitals, clinics and practitioners who
dispense controlled substances shall maintain inventories and records of
controlled substances listed in schedules II and II-N separately from all of
the other prescription records.
B. “Readily retrievable” means records kept in such a manner as
to be easily separated out from all other records in a reasonable time or
records are kept on which certain items are redlined, starred or in some manner
are visually identifiable apart from other items appearing on the record.
[16.19.20.25
NMAC - Rp 16.19.20.25 NMAC, 06-26-2018]
16.19.20.26 PROCUREMENT RECORDS: “Order forms” refer to
DEA form 222 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, 06-26-2018]
16.19.20.27 ORDER FORMS AS RECORDS: Order forms for schedule I and
II controlled substances shall be deemed proper record of receipt, if the
purchaser records on copy 3 of the order form the number of commercial or bulk
containers furnished of each item and the date on which such containers are
received by the purchaser.
[16.19.20.27
NMAC - Rp 16 19.20.27 NMAC, 06-26-2018]
16.19.20.28 INVENTORY RECORDS: All schedule I and II narcotic
substance inventory records and procurement records will be kept separate from other
records of the registrant.
[16.19.20.28
NMAC - Rp 16 19.20.28 NMAC, 06-26-2018]
16.19.20.29 PROCUREMENT RECORDS: Procurement records, other than
the inventory, may be kept at a central location, rather than at the registered
location, if prior approval has been obtained under the federal regulations;
provided such records are delivered, upon request of the board, to the
registered location within 48 hours of such request.
[16.19.20.29
NMAC - Rp 16 19.20.29 NMAC, 06-26-2018]
16.19.20.30 DISPOSITION RECORDS: Practitioner’s disposition
records shall include date of dispensing, name of patient, name and strength of
substance and amount dispensed.
[16.19.20.30
NMAC - Rp 16 19.20.30 NMAC, 06-26-2018]
16.19.20.31 PHARMACY AND HOSPITAL PRESCRIPTION AND
DISPENSING RECORDS:
A. Prescriptions for schedule II shall be maintained in a
separate file.
B. In pharmacies without computerized prescription information,
prescriptions for schedules II, III, IV and V shall have the name of the
dispensing pharmacist and the date filled inscribed on the face of the
prescription. (Typewritten, printed or
rubber stamp are acceptable.)
C. Prescriptions for schedule III, IV and V shall be maintained
either in a separate file only, or in such form that they are readily retrievable
from other records of the pharmacy.
“Readily retrievable” means that at the time of filing, the face of the
prescription is stamped in red ink in the lower right hand corner with the
letter “C” no less than 1 inch high, or the records comply with 16.19.6.22 NMAC
“Computerized Prescription Information”.
D. Prescriptions so marked may then be filed with prescriptions
for schedule II substances, or in the usual consecutively numbered prescription
file for non-controlled drugs.
E. Pharmacies employing automatic data processing
systems or other electronic record keeping systems for prescriptions must
comply with 16.19.6.22 NMAC “Computerized Prescription Information”.
F. Hospital floor stock records. A record of controlled substances
administered from floor stock shall contain the following information:
(1) name of patient;
(2) date and time administered;
(3) name of drug;
(4) strength of drug;
(5) amount administered;
(6) name of prescribing physician;
(7) name of person administering the
controlled substance.
[16.19.20.31
NMAC - Rp 16 19.20.31 NMAC, 06-26-2018]
16.19.20.32 RESEARCH DISPOSITION RECORDS:
A. A registered person using any controlled substance under FDA
regulations in research at a registered establishment which maintains records
in accordance with FDA approved research requirements is not required to keep
records if he notifies the DEA and the board of pharmacy of the name, address
and all registration numbers of establishments maintaining such records.
B. A registered person using any controlled substance in
preclinical research or in teaching at a registered establishment which
maintains records of such substances is not required to keep records if he
notifies the DEA and the board of pharmacy of the name, address and all registration
numbers of the establishments maintaining the records.
[16.19.20.32
NMAC - Rp 16 19.20.32 NMAC, 06-26-2018]
16.19.20.33 MANUFACTURERS AND REPACKAGERS:
A. Disposition records shall be maintained on all
controlled substances. Schedule I and II
records shall be maintained separately from all other records.
B. Disposition records for schedules III, IV and V shall
be maintained either separately from all other records or in such form that the
information required is readily retrievable from the ordinary business records
of the registrant.
[16.19.20.33
NMAC - Rp 16 19.20.33 NMAC, 06-26-2018]
16.19.20.34 WHOLESALE DISTRIBUTORS: Wholesale distributors
disposition records shall contain the same information required of
manufacturers.
[16.19.20.34
NMAC - Rp 16 19.20.34 NMAC, 06-26-2018]
16.19.20.35 ANALYTICAL LABORATORIES RECORDS: Analytical laboratories records
shall include:
A. name of substance;
B. the
form or forms in which substance is received, imported or manufactured and the
concentration of the substance;
C. quantity
and strength received;
D. date
of receipt;
E. name and DEA registry number of supplier;
F. adequate record of distribution.
[16.19.20.35
NMAC - Rp 16.19.20.35 NMAC, 06-26-2018]
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, 06-26-2018]
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).
[16.19.20.37
NMAC - Rp 16 19.20.37 NMAC, 06-26-2018]
16.19.20.38 DISPOSITION OF DAMAGED, 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.
[16.19.20.38
NMAC -Rp 16.19.20.38 NMAC, 06-26-2018]
16.19.20.39 EXEMPTION FOR PHARMACY REGISTRATION AS
A DISTRIBUTOR, DISTRIBUTION BY A DISPENSER TO ANOTHER PRACTITIONER REGISTERED
TO DISPENSE CONTROLLED SUBSTANCES:
A
registrant who is registered to dispense controlled substances may distribute a
quantity of such substances to a registered practitioner for general dispensing
to his patients if:
A. the distribution is recorded by the pharmacist indicating
the number of units or volume of such finished forms and commercial containers
dispensed, the date and manner of disposition;
B. the same information is recorded as a procurement by the
registrant receiving the substance;
C. if the substance is listed in schedule I or II, an order
form is used as required by the federal regulations;
D. the total number of dosage units of all controlled
substances distributed by the pharmacy by this method during the 12 month
period in which the practitioner is registered to dispense does not exceed five
percent of the total number of dosage units of all controlled substances
distributed and dispensed by the pharmacy during the 12 month period.
[16.19.20.39
NMAC - Rp 16 19.20.39 NMAC, 06-26-2018]
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 NMAC, board of pharmacy
regulations to Title 21, Section 1304.11-1304.14 of the federal DEA
regulations. 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).
(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 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 NMAC.
[16.19.20.40
NMAC - Rp 16 19.20.40 NMAC, 06-26-2018]
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.
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, 06-26-2018]
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.
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 meets all of the requirements of Part 1306.08 of the
Code of Federal Regulations.
B. 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. The original prescription shall be maintained
in accordance with 16.19.20.31 NMAC.
C. A prescription prepared in accordance with Subsection A of
16.19.20.41 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. A prescription prepared in accordance with Subsection A of
16.19.20.41 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. A prescription prepared in accordance with Subsection A of
16.19.20.41 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. A pharmacist may dispense directly a controlled substance
listed in schedule III or IV, which is a prescription drug as determined under
the New Mexico Drugs and Cosmetics 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. 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, 06-26-2018]
16.19.20.43 PRESCRIPTIONS NOT TO BE REFILLED: Prescriptions for schedule II
drugs may not be refilled.
[16.19.20.43
NMAC - Rp 16.19.20.43 NMAC, 06-26-2018]
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, 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, 06-26-2018]
16.19.20.45 PRESCRIPTION FILL AND REFILL REQUIREMENTS:
A. Prescriptions for any controlled substance shall not be
filled more than six months after the date of issue.
(1) Controlled
substance prescriptions dispensed directly to a patient shall not be refilled
before seventy-five percent of the prescription days’ supply has passed, unless
the practitioner authorizes the early refill, which must be documented by the
pharmacist.
(2) Controlled
substance prescriptions delivered to a patient indirectly (as mail order) to a
patient shall not be refilled before sixty-six percent of a 90 day supply has
passed or fifty percent of a 30 day supply has passed, unless the practitioner
authorizes the early refill, which must be documented by the pharmacist.
B. Prescriptions for schedule III, IV, or V controlled
substances shall not be filled or refilled more than six months after the date
of issue or be refilled more than five times unless renewed by the practitioner
and a new prescription is placed in the pharmacy files.
[16.19.20.45
NMAC - Rp 16 19.20.45 NMAC, 06-26-2018]
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.
B. A prescription
for a controlled substance in schedule II initially filled later than 30 days
after the date written 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
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, 06-26-2018]
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 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, 06-26-2018]
16.19.20.48 SECURITY REQUIREMENTS:
A. All applicants and registrants shall provide effective
controls and procedures to guard against theft and diversion of controlled
substances.
B. In evaluating the overall security system of a registrant or
applicant, the following factors may be considered, where applicable to the
need for strict compliance with security requirements:
(1) the type of activity;
(2) the type and form of controlled
substances handled;
(3) the quantity of controlled substances
handled;
(4) the location of the premises and
relationship such location bears on security needs;
(5) the type of building construction of
the facility and the general characteristics of the building;
(6) the type of vault, safe, and secure
enclosures or other storage system used;
(7) the type of closures on vaults,
safes, and secure enclosures;
(8) the adequacy of key control systems
and lock control system;
(9) the extent of unsupervised public
access to the facility;
(10) the adequacy of supervision over
employees having access to storage or distribution areas;
(11) the procedures for handling business
guests, visitors, maintenance personnel and non-employee service personnel;
(12) the adequacy of the
registrant’s or applicant’s system for monitoring the receipt, manufacture,
distribution and disposition of controlled substances in its operation.
[16.19.20.48
NMAC - Rp 16 19.20.48 NMAC, 06-26-2018]
16.19.20.49 MANUFACTURERS, REPACKAGERS AND
WHOLESALE DISTRIBUTORS:
Security
requirements which meet the federal DEA provision shall be deemed adequate
under New Mexico Controlled Substances Act.
[16.19.20.49
NMAC - Rp 16 19.20.49 NMAC, 06-26-2018]
16.19.20.50 PHARMACIES AND HOSPITALS, EMPLOYING
STAFF PHARMACISTS: Controlled substances
listed in schedule I shall be stored in a securely locked, substantially
constructed cabinet. Controlled
substances listed in schedule II, III, IV and V shall be stored either in
securely locked, substantially constructed cabinets or dispersed throughout the
stock of non-controlled substances in such a manner as to obstruct the theft or
diversion of the substances.
[16.19.20.50
NMAC - Rp 16.19.20.50 NMAC, 06-26-2018]
16.19.20.51 HOSPITALS SERVED BY CONSULTANT OR
PART-TIME PHARMACISTS, CLINICS AND PHYSICIANS: Controlled substances listed in schedule I through V shall
be stored in a securely locked, substantially constructed cabinet.
[16.19.20.51
NMAC - Rp 16 19.20.51 NMAC, 06-26-2018]
16.19.20.52 RESEARCH REGISTRANTS AND CHEMICAL
ANALYSIS LABORATORIES:
Controlled
substances listed in schedules I and II shall be stored in a securely locked,
substantially constructed cabinet.
Schedules III, IV and V substances shall be stored either in a securely
locked, substantially constructed cabinet or dispersed in with the stock of
non-controlled substances in such a manner as to obstruct the theft or
diversion of the substances.
[16.19.20.52
NMAC - Rp 16.19.20.52 NMAC, 06-26-2018]
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-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, 06-26-2018]
16.19.20.54 EXEMPTED OVER-THE-COUNTER DRUGS: (Information published by DEA.)
[16.19.20.54
NMAC - Rp 16 19.20.54 NMAC, 06-26-2018]
16.19.20.55 EXEMPT CHEMICAL PREPARATIONS: The board hereby exempts such
chemical preparations and mixtures which are intended for laboratory,
industrial, educational, or special research purposes, which are not intended
for general administration to a human being or other animal and which:
A. contains
no narcotic controlled substances and is packaged in such a form or
concentration that the package quantity does not present any significant
potential for abuse, or;
B. contains
either a narcotic or nonnarcotic controlled substance and one or more
adulterating or denaturing agent in such a manner, combination, quantity,
proportion or concentration, that the preparation or mixture does not present
any potential for abuse, and the narcotic substance cannot in practice be
removed, and;
C. are
exempt from federal regulations (CFR 21 Part 1308.24).
[16.19.20.55
NMAC - Rp 16 19.20.55 NMAC, 06-26-2018]
16.19.20.56 HEARINGS, DENIAL OF REGISTRATION,
REVOCATION OR SUSPENSION OF REGISTRATION:
Proceedings to suspend or revoke a registration or to refuse renewal of
a registration shall be held pursuant to the Uniform Licensing Act.
[16.19.20.56
NMAC - Rp 16 19.20.56 NMAC, 06-26-2018]
16.19.20.57 ADMINISTRATIVE INSPECTION - DEFINED: Administrative inspection means - the
inspection of any place where registrants are permitted to hold, manufacture,
compound, process, sell, deliver, or otherwise dispose of any controlled
substances. When authorized by an
administrative inspection warrant, the inspector may:
A. inspect and copy records required by the Controlled
Substances Act;
B. inspect the restricted area and all pertinent equipment, all
container substances, containers and labeling found at the controlled area;
C. make a physical inventory of specific items or all
controlled substances on-hand at the premises;
D. collect samples, if applicable;
E. check records and information of distribution of controlled
substances by the registrant as they relate to total distribution;
F. examination of records, invoices, appropriate for
verification of the records or otherwise bearing on the provisions of the
Controlled Substances Act.
[16.20.20.57
NMAC - Rp 16 19.20.57 NMAC, 06-26-2018]
16.19.20.58 VOLUNTARY CONSENT TO INSPECTION: The board inspector will ask the
registrant to voluntarily consent to the inspection. He will inform the registrant of his
constitutional rights to an inspection warrant, however, if the registrant
consents to inspection without warrant, the inspector will obtain a signed
consent waiver statement from the registrant before proceeding with an
accountability audit or inspection.
[16.19.20.58
NMAC - Rp 16 19.20.58 NMAC, 06-26-2018]
16.19.20.59 WRITTEN CONSENT:
A. The written consent shall contain the following information:
(1) that the owner, or agent in charge of
the premises has been informed of his constitutional right not to have an
administrative inspection made without an administrative inspection warrant;
(2) of his right to refuse to consent to
such an inspection;
(3) of the possibility that anything of
an incriminating nature which may be found may be seized and used against him
in a board hearing or a criminal prosecution;
(4) that he had been presented with a
notice of inspection;
(5) that the consent given by him is
voluntary and without threats of any kind; and
(6) that he may withdraw his consent at
any time during the course of inspection.
B. Written consent shall be produced in duplicate and one copy
shall be retained by the person being inspected and one copy shall be retained
by the inspector for filing in the board office.
[16.19.20.59
NMAC - Rp 16.19.20.59 NMAC, 06-26-2018]
16.19.20.60 ADMINISTRATIVE WARRANT:
A. A copy of the administrative warrant need not be
given to the registrant unless items are seized or confiscated.
B. To serve the warrant, all that is required is to announce
possession of it, the contents of the warrant need not be stated to the person
upon whom the warrant is served.
[16.19.20.60
NMAC - Rp 16 19.20.60 NMAC, 06-26-2018]
16.19.20.61 CONSENT TO CHARGES: Unless the person in charge of the premises
so consents in writing, these regulations shall not extend to financial data,
sales data other than shipping date, or pricing data.
[16.19.20.61
NMAC - Rp 16 19.20.61 NMAC, 06-26-2018]
16.19.20.62 ADMINISTRATIVE WARRANT - NOT REQUIRED: An administrative warrant shall
not be required for a new pharmacy or drug distribution facility applying for
initial registration under the Controlled Substances Act or the Pharmacy Act,
or in any other situation where a warrant is not constitutionally required.
[16.19.20.62
NMAC - Rp 16 19.20.62 NMAC, 06-26-2018]
16.19.20.63 ADMINISTRATIVE WARRANT - REFUSAL: If a registrant or any person
subject to the Controlled Substances Act refuses to permit execution of an
administrative warrant or impedes the inspection in the execution of that
warrant, he shall be advised that such refusal or action constitutes a
violation of Section 30-31-32 NMSA 1978, Controlled Substances Act.
[16.19.20.63
NMAC - Rp 16 19.20.63 NMAC, 06-26-2018]
16.19.20.64 CONTROLLED SUBSTANCE PRECURSORS: See 16.19.21 NMAC - Drug
Precursors
[16.19.20.64
NMAC - Rp 16 19.20.64 NMAC, 06-06-2018]
16.19.20.65 SCHEDULE I:
A. Section 30-31-6 NMSA 1978, schedule I shall consist of the
following drugs and other substances, by whatever name, common or usual name,
chemical name or brand name designated, listed in this section; OPIOIDS,
unless specifically exempt or unless listed in another schedule, any of the
following opioids, including its isomers, esters, ethers, salts and salts of
isomers, esters, and ethers, whenever the existence of such isomers, esters,
ethers, and salts is possible within the specific chemical designation.
(1) Acetylmethadol
(2) Allylprodine
(3) Alphacetylmethadol
(4) Alphameprodine
(5) Alphamethadol
(6) Alpha-methyl fentanyl
(7) Benzethidine
(8) Betacetylmethadol
(9) Betameprodine
(10) Betamethadol
(11) Betaprodine
(12) Clonitazene
(13) Desmethyltramadol
(14) Dextromoramide
(15) Diampromide
(16) Diethylthiambutene
(17) Dimethylthiambutene
(18) Difenoxin
(19) Dimenoxadol
(20) Dimepheptanol
(21) Dimethylthiambutene
(22) Dioxaphetyl Butyrate
(23) Dipipanone
(24) Ethylmethylthiambutene
(25) Etonitazene
(26) Etoxeridine
(27) Furethidine
(28) Hydroxypethidine
(29) Ketobemidone
(30) Levomoramide
(31) Levophenacylmorphan
(32) Morpheridine
(33) Noracymethadol
(34) Norlevorphanol
(35) Normethadone
(36) Norpipanone
(37) Phenadoxone
(38) Phenampromide
(39) Phenomorphan
(40) Phenoperidine
(41) Piritramide
(42) Proheptazine
(43) Properidine
(44) Propiram
(45) Racemoramide
(46) Tilidine
(47) Trimeperidine
(48) U-48800;
(2-(2,4-dichlorophenyl)-N-((1S,2S)-2-(dimethylamino)cyclohexyl)-N-methylacetamide,
monohydrochloride
(49) U-49900;
(trans-3,4-dichloro-N-[2-(diethylamino)cyclohexyl]-N-methyl-benzamide
(50) Beta-Hydroxy-3-Methylfentanyl
(51) 3-Methylthiofentanyl
(52) Acetyl-Alpha-Methyl fentanyl
(53) Alpha-Methylthiofentanyl
(54) Beta-hydroxfentanyl
(55) Para-Fluoro fentanyl
(56) Thiofentanyl
(57) Acetyl
fentanyl
(58) Butyryl
fentanyl
(59) Betahydroxythiofentanyl
(60) Furanyl
fentanyl
(61) AH-7921;
(3,4-dichloro-N-[(1-dimethylamino)cyclohexylmethyl]benzamide)
(62) U47700;
(trans-3,4-dichloro-N-(2-(dimethylamino)cyclohexyl)-N-methylbenzamide)
(63) MT-45;
(1-(4-Nitrophenylethyl)piperidylidene-2-(4-chlorophenyl)sulfonamide)
(64) W-15;
(4-chloro-N-[1-(2-phenylethyl)-2-piperidinylidene]-benzenesulfonamide)
(65) W-18;
(1-(4-Nitrophenylethyl)piperidylidene-2-(4-chlorophenyl)sulfonamide)
(66) U-50488;
(2-(3,4-dichlorophenyl)-N-methyl-N-[(1R,2R)-2-pyrrolidin-1-
ylcyclohexyl]acetamide)
(67) U50488H;
((-)(trans)-3,4-dichloro-N-methyl-N-[2-(1-pyrrolidiny)cyclo-
hexyl]benzeneacetamide)
(68) Fentanyl-related
substances, their isomers, esters, ethers, salts, and salts of isomers, esters
and ethers. Fentanyl-related substance
means any substance, unless specifically exempted or unless listed in another
schedule, that is structurally related to fentanyl by one or more of the
following modifications:
(a) replacement
of the phenyl portion of the phenethyl group by any monocycle, whether or not
further substituted in or on the monocycle;
(b) substitution
in or on the phenethyl group with alkyl, alkenyl, alkoxyl, hydroxyl, halo,
haloalkyl, amino or nitro groups;
(c) substitution
in or on the piperidine ring with alkyl, alkenyl, alkoxyl, ester, ether, hydroxyl,
halo, haloalkyl, amino or nitro groups;
(d) replacement
of the aniline ring with any aromatic monocycle whether or not further
substituted in or on the aromatic monocycle; or
(e) replacement
of the N-propionyl group by another acyl group; or
(f) any combination of the above
substances include, but are not limited to, the following substances:
(i) Acrylfentanyl
(ii) 4F-butyrfentanyl
(iii) 4-methoxybutyrfentanyl
(iv) Fluorobutyrfentanyl
(v) Fluorofentanyl
(vi) FIBF;
(Para Fluoro Isobutyryl Fentanyl)
(vii) Cyclopropyl
fentanyl
(viii) Thiofuranyl
fentanyl (Thiophene fentanyl)
(ix) 3-methylfentanyl
(N-3-methyl-1-(2-phenyl-ethyl)-4-Piperidyl)-N-phenylpropanamide, its optical
and geometric isomers, salts and salts of isomers.
B. OPIUM DERIVATIVES:
Unless
specifically exempt or unless listed in another schedule, any of the following
opium derivatives, 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) Acetorphine
(2) Acetyl dihydrocodeine
(3) Benzyl morphine
(4) Codeine methylbromide
(5) Codeine-N-Oxide
(6) Cyprenorphine
(7) Desomorphine
(8) Dehydro morphine
(9) Etorphine
(10) Heroin
(11) Hydromorphinol
(12) Methyldesorphine
(13) Methyldihydromorphine
(14) Morphine methylbromide
(15) Morphine methylsulfonate
(16) Morphine-N-Oxide
(17) Myrophine
(18) Nicocodeine
(19) Nicomorphine
(20) Normorphine
(21) Pholcodine
(22) Thebacon
(23) Drotebanol
(24) 6AM; (6-acetylmorphine)
C. STIMULANTS:
Unless specifically exempted 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) Fenethylline
(2) N-ethylamphetamine
(3) cis-4-methylaminorex
(4) N, N-dimethylamphetamine
(5) (BZP), 1-benzylpiperazine;
N-benzylpiperazine
(6) (DCPP); 2,3-dichlorophenylpiperazine
(7) (DBZP);
dibenzylpiperazine
(8) (MBZP);
methylbenzylpiperazine
(9) (mCPP);
meta-chlorophenylpiperazine
(10) (MDBZP); methylenedioxybenzylpiperazine
(11) (meOPP); para-methoxyphenylpiperazine
(12) (pCPP);
para-chlorophenylpiperazine
(13) (pFPP);
para-fluorophenylpiperazine
(14) (2-DPMP), desoxypipradrol;
2-diphenylmethylpiperidine
(15) D2PM, diphenylprolinol;
diphenyl-2-pyrrolidinemethanol
(16) HDMP-28; methylnaphthidate
(17) Nocaine, (+)-CPCA;
3α-carbomethoxy-4β-(4-chlorophenyl)-N-methylpiperidine
(18) BTQ or
butyltolylquinuclidine; (2-Butyl-3-(p-tolyl)quinuclidine
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) Pinazepam
(r) Tetrazepam
(s) Flubromazepan
(t) 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
E. HALLUCINOGENIC SUBSTANCES:
Unless specifically exempt or unless listed in another schedule, any
material, compound, mixture or preparation, which contains any quantity of the
following hallucinogenic substances, or which contains any of 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 (for
purpose of this sub-section only, the term “isomers” includes the optical,
positional, and geometric isomers).
(1) 3,4 -methylenedioxy amphetamine
(2) 5 - methoxy - 3,4-methylenedioxy
amphetamine
(3) 3,4,5 -trimethoxy amphetamine
(4) Bufotenine
(5) DET; (Diethyltryptamine)
(6) DMT; (Dimethyltryptamine)
(7) DOM or STP;
(4-methyl-2,5-dimethoxy amphetamine)
(8) Lysergic
acid amide
(9) Lysergic acid diethylamide
(10) Marijuana
(11) Mescaline
(12) Peyote
(13) N-ethyl-3-piperidyl benzilate
(14) N-methyl-3-piperidyl benzilate
(15) Psilocybin
(16) Psilocyn
(17) Tetrahydrocannabinols
(18) Parahexyl (synthetic analog of
delta‑9‑tetrahydrocannabinol (THC) an active ingredient of
cannabis)
(19) Hashish
(20) 2, 5 -dimethoxyamphetamine; 2,
5-DMA
(21) 4-bromo-2,
5-dimethoxy-amphetamine; 2, 5-DMA
(22) PMA; 4-methoxyamphetamine
(23) PCE; (Ethylamine
N-ethyl-1-phenylcyclohexylamine)
(24) Pyrrolidine
1-(1-phenylcyclohexyl)-pyrrolidine (PCPy), (PHP) analog of the drug
phencyclidine
(25) Thiophene (analog of
phencyclidine) TCP or TPCP
(26) Alpha-ethyltryptamine
(27) 2, 5-dimethoxy-4-ethylamphet-amine
(28) Ibogaine
(29) 2C-T-7;
(2,5-dimethoxy-4-(n)-propylthiophenethylamine)
(30) AMT; (Alpha-methyltryptamine)
(31) 5-MeO-DIPT;
(5-methoxy-N,N-diisopropyltryptamine)
(32) 25B-NBOMe;
(2-(4-bromo-2.5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine)
(33) 25C-NBOMe;
(2-(4-chloro-2.5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine)
(34) 25I-NBOMe;
(2-(4-iodo-2.5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine)
(35) Synthetic cannabinoids: Unless specifically exempted or unless listed
in another schedule, any
material, compound, mixture or preparation which contains any quantity of the
following synthetic cannabinoids which demonstrates binding activity to the
cannabinoid receptor or analogs or homologs with binding activity. Substances include but are not limited to:
(a) CP 55,244
((hydroxymethyl)-4-[2-hydroxy-4-(2-methyloctan-2-yl)phenyl]
1,2,3,4,4a,5,6,7,8,8a-decahydronaphthalen-2-ol)
(b) CP
55,940 (5-hydroxy-2-(3-hydroxypropyl) cyclohexyl]-5-(2-methyloctan-2-yl)phenol)
(c) JWH-081
(1-pentyl-3-[1-(4-methoxynaphthoy)]indole)
(d) JWH-122
(1-pentyl-3-(4-methyl-1-naphthoyl)indole)
(e) JWH-133
3-(1,1-dimethylbutyl)-6a,7,10,10a-tetrahydro -6,6,9-trimethyl-6H
dibenzo[b,d]pyran
(f) JWH
203 1-pentyl-3-(2-chlorophenylacetyl)indole)
(g) JWH
210 4-ethylnaphthalen-1-yl-(1-pentylindol-3-yl)methanone
(h) AM-694
(1-(5-fluoropentyl)-3-(2-iodobenzoyl)indole)
(i) AM-1221
(1-(N-methylpiperdin-2-yl)methyl-2-methyl-3-(1-naphthoyl)-6-nitroindole
(j) AM-2201
(1-(5-fluoropentyl)-3-(1-naphthoyl)indole)
(k) RCS-4
or SR-19 (1-pentyl-3-[(4-methoxy)-benzoyl]indole)
(l) RCS-8
or SR-18 (1-cyclohexylethyl-3-(2-methoxyphenylacetyl)indole);
(m) JWH-210
(1-pentyl-3-(4-ethylnaphthoyl)indole)
(n) WIN-49,098
(Pravadoline) (4-methoxyphenyl)-[2-methyl-1-(2-morpholin-4-ylethyl)indol-3-yl]methanone
(o) WIN-55,212-2
(2,3-dihydro-5-methyl-3-(4-morpholinylmethyl)pyrrolo-1,4-benzooxazin6-
yl)-1-naphthalenylmethanone)
(p) any of the
following synthetic cannabinoids, their salts, isomers, and salts of isomers,
unless specifically excepted, whenever the existence of these salts, isomers,
and salts of isomers is possible within the specific chemical designation;
(i) naphthoylindoles:
any compound containing a 3-(1- naphthoyl) indole structure with substitution
at the nitrogen atom of the indole ring by an alkyl, haloalkyl, alkenyl,
cycloalkylmethyl, cycloalkylethyl, 1-(N-methyl-2-piperidinyl) methyl, or
2-(4-morpholinyl) ethyl group, whether or not further substituted in the indole
ring to any extent and whether or not substituted in the naphthyl ring to any
extent including, but not limited to, JWH-015, JWH-018, JWH-019, JWH-073,
JWH-081, JWH-122, JWH-200, JWH-210, JWH-398 and AM-2201;
(ii) naphthylmethylindoles:
any compound containing a1Hindol- 3-yl-(1-naphthyl) methane structure with
substitution at the nitrogen atom of the indole ring by an alkyl, haloalkyl,
alkenyl, cycloalkylmethyl, cycloalkylethyl, 1-(N-methyl-2-piperidinyl) methyl,
or 2-(4-morpholinyl) ethyl group, whether or not further substituted in the indole
ring to any extent and whether or not substituted in the naphthyl ring to any
extent including, but not limited to, JWH-175, JWH-184, and JWH-199;
(iii) naphthoylpyrroles:
any compound containing a 3-(1- naphthoyl) pyrrole structure with substitution
at the nitrogen atom of the pyrrole ring by an alkyl, haloalkyl, alkenyl,
cycloalkylmethyl, cycloalkylethyl, 1-(N-methyl-2-piperidinyl) methyl, or
2-(4-morpholinyl) ethyl group, whether or not further substituted in the
pyrrole ring to any extent and whether or not substituted in the naphthyl ring
to any extent including, but not limited to, JWH-307;
(iv) naphthylmethylindenes:
any compound containing a naphthylideneindene structure with substitution at
the 3-position of the indene ring by an alkyl, haloalkyl, alkenyl,
cycloalkylmethyl,
cycloalkylethyl, 1-(N-methyl-2-piperidinyl) methyl, or 2-(4-morpholinyl) ethyl
group, whether or not further substituted in the indene ring to any extent and
whether or not substituted in the naphthyl ring to any extent including, but
not limited to, JWH-176;
(v) phenylacetylindoles:
any compound containing a 3- phenylacetylindole structure with substitution at
the nitrogen atom of the indole ring by an alkyl, haloalkyl, alkenyl,
cycloalkylmethyl, cycloalkylethyl, 1-(N-methyl-2-piperidinyl) methyl, or
2-(4-morpholinyl) ethyl group, whether or not further substituted in the indole
ring to any extent and whether or not substituted in the phenyl ring to any
extent including, but not limited to, JWH-203, JWH-250, JWH-251, and RCS-8;
(vi) cyclohexylphenols:
any compound containing a 2-(3- hydroxycyclohexyl) phenol structure with
substitution at the 5- position of the phenolic ring by an alkyl, haloalkyl,
alkenyl, cycloalkylmethyl, cycloalkylethyl, 1-(N-methyl-2-piperidinyl) methyl,
or 2-(4-morpholinyl) ethyl group, whether or not substituted in the cyclohexyl
ring to any extent including, but not limited to, Cannabicyclohexanol (CP
47,497 C8 homologue), CP 47,497 and CP 55,490;
(vii) benzoylindoles:
any compound containing a 3-(benzoyl) [ 5 ] OTS-3833.4 indole structure with
substitution at the nitrogen atom of the indole ring by an alkyl, haloalkyl,
alkenyl, cycloalkylmethyl, cycloalkylethyl, 1-(N-methyl-2-piperidinyl) methyl,
or 2-(4- morpholinyl) ethyl group, whether or not further substituted in the
indole ring to any extent and whether or not substituted in the phenyl ring to
any extent including, but not limited to, AM-694, Pravadoline (WIN 48,098),
RCS-4, and AM-1241;
(q) UR-144
1-(pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone
(r) XLR11
1-(5-fluoro-pentyl)-1H-indol-3-yl(2,2,3,3-tetramethylcyclopropyl)methanone
(s) AKB48
N-(1-adamantyl)-1-pentyl-1H-indazole-3-carboxamide
(t) QUPIC;
Quinolin-8-yl 1-pentyl-1H-indole-3-carboxylate
(u) 5-fluoro-PB22; 5F-PB22; Quinolin-8-yl
1-(5-fluropentyl-1H-indole-3-carboxylate
(v) AB-FUBINACA;
N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(4-flurobenzyl)-1H-indazole-3-carboxamide
(w) ADB-PINACA; N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamine
(x) AB-CHMINACA;
N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide
(y) AB-PINACA;
N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide
(z) THJ-2201;
[1-(5-fluropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone
(aa) FDU-PB-22 IUPAC: 1-Naphthyl 1-(4-fluorobenzyl)-1H-indole-3
carboxylate
(bb) 5-fluoro ABICA:
N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(5-fluoropentyl)-1H-indole-3-carboxamide
(cc) FUB-144 or FUB-UR-144;
[1-(4-fluorobenzyl)-1H-indol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone
(dd) MN-18;
N-(1-Naphthyl)-1-pentyl-1H-indazole-3-carboxamide
(ee) FUB-PB-22; Quinolin-8-yl
1-(4-fluorobenzyl)-1H-indole-3-carboxylate
(ff) ADB-CHMINACA
(N-[1-(aminocarbonyl)-2,2-dimethylpropyl]-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide)
(gg) AMB-FUBINACA or FUB-AMB (methyl(1-(4-fluorobenzyl)-1H-indazole-3-carbonyl)-L-valinate)
(hh) 5-fluoro-AMB (N-[[1-(5-fluoropentyl)-1H-indazol-3-yl]carbonyl]-L-valine,
methyl ester)
(ii) 5-fluoro-ADB
(N-[[1-(5-fluoropentyl)-1H-indazol-3-yl]carbonyl]-3-methyl-D-valine, methyl
ester)
(jj) Bk-DMBDB or dibutylone;
1-(Benzo[d][1,3]dioxol-5-yl)-2-(dimethylamino)butan-1-one
(kk) MMB-FUBINACA; methyl
(1-(4-fluorobenzyl)-1H-indazole-3-carbonyl)-L-valinate
(ll) MDMB-CHMICA; methyl
(S)-2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3-dimethylbutanoate
(mm) NM2201; Naphthalen-1-yl
1-(5-fluoropentyl)-1H-indole-3-carboxylate
(nn) 5-Fluoro-AKB48 or
5F-APINACA;
N-((3s,5s,7s)-adamanta-1-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide
(oo) 5-Fluoro-ADB;
Methyl(S)-2-[1-(5-fluoropentyl)-1H-indazole-3-carboxamido]-3,3-dimethylbutanoate
(pp) 5-Fluoro-AMB; N-[[1-(5-fluoropentyl)-1H-indazol-3-yl]carbonyl]-L-valine,methyl
ester
(qq) MAB-CHMINACA;
N-[1-(aminocarbonyl)-2,2-dimethylpropyl]-1-(cycohexylmethyl)-1H-indazole-3-carboxamide
(rr) SDB-006;
N-benxyl-1-pentyl-1H-indole-3-carboxamide
(ss) Cumyl-PINACA;
1-pentyl-N-(2-phenylpropan-2-yl)-1H-indazole-3-carboxamide
(tt) Cumyl-PICA;
1-pentyl-N-(2-phenylpropan-2-yl)-1H-indole-3-carboxamide
(36) Substances
determined by the board to have the pharmacological effect of the substance,
the risk to the public health by abuse of the substance and the potential of
the substance to produce psychic or physiological dependence liability is
similar to the substances described in Paragraph (1) or (2) of 30-31-23C NMSA
1978. Substances include but are not
limited to:
(a) Salvia
divinorum
(b) Salvinorin
A (methyl (2S,4aR,6aR,7R,9S,10aS,10bR)-9-(acetyloxy)-2-(furan-3-yl)-6a,10b-dimethyl-4,10-dioxododecahydro-2H-benzo[f]isochromene-7-carboxylate)
(37) (4-MEC); 4-methyl-ethylcathinone
(38) (4-EMC); 4-ethyl-methcathinone
(39) Ethcathinone;
2-ethylamino-1-phenyl-propan-1-one
(40) Ethylone;
3’,4’-methylenedioxyethcathinone
(41) Bk-MBDB, butylone;
beta-keto-N-methyl-3,4-benzodioxyolybutanamine
(42) (NRG-1), naphyrone;
naphthylpyrovalerone
(43) Metamfepramone; N,N-dimethylcathinone
(44) Alpha-PPP;
alpha-pyrrolidinopropiophenone
(45) (α-PBP);
alpha-pyrrolidinobutiophenone
(46) (MOPPP);
4’-methoxy-alpha-pyrrolidinopropiophenone
(47) (MαPPP);
4’-methyl-α-pyrrolidinopropiophenone
(48) (MDPPP);
3’,4’-methylenedioxy-alpha-pyrrolidinopropiophenone
(49) (MDPBP);
3’,4’-methylenedioxy-alpha-pyrrolidinobutiophenone
(50) (MPBP);
4’-methyl-α-pyrrolidinobutiophenone
(51) Alpha-PVP;
alpha-pyrrolidinovalerophenone
(52) (MDAI); 5,6-methylenedioxy-2-aminoindane
(53) Buphedrone;
alpha-methylamino-butyrophenone
(54) Eutylone;
beta-keto-ethylbenzodioxolylbutanamine
(55) beta-keto-ethylbenzodioxolylpentanamine
(56) beta-keto-methylbenzodioxolylpentanamine
(pentylone)
(57) 4-Bromo-2,5-dimethoxyphenethylamine
(2c-B, Nexus)
(58) N-hydroxy-3,4-methylenedioxyamphetamine
(also known as N-hydroxy-alphamethyl-3,4(methylenedioxy)-phenethylamine, and
N-hydroxy MDA
(59) 5-methoxy-N,N-dimethyltryptamine
(5-methoxy-3-[2-(dimethylamino)ethyl]indole; 5-MeO-DMT
(60) Mephedrone; 4-methylmethcathinone
(61) (MDPV); 3,4-methylenedioxypyrovalerone
(62) (2C-E);
2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine
(63) (2C-D);
2-(2,5-Dimethoxy-4-methylphenyl)ethanamine
(64) (2C-T-2); 2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine
(65) (2C-T4);
2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine
(66) (2C-H);
2-(2,5-Dimethoxyphenyl)ethanamine
(67) (2C-N);
2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine
(68) (2C-P); 2-(2,5-Dimethoxy-4-(n)-propylphenyl)ethanamine
(69) Methylone;
3,4-Methylenedioxy-N-methylcathinone
(70) Aminorex (2-amino-5-phenyl-2-oxazoline)
(71) Pentedrone
(72) 4-FMC or flephedrone;
4-fluro-N-methylcathinone
(73) (3-FMC); 3-fluro-N-methylcathinone
(74) (3-MMC); 3-methylmethcathinone
(75) (3,4 DMMC); 3,4-Dimethylmethcathinone
(76) (3-MEC); 3-Methyl-N-ethylcathinone
(77) 4-methylbuphedrone or 4-MeBP;
2-methylamino-1-(4-methylphenyl)butan-1-one
(78) (4 MTA); 4-methylthioamphetamine
(79) (5-Me MDA);
5-methyl-3,4-methylenedioxyamphetamine
(80) (6-APB); 6-benzofuran
(81) (PMA); 4-methoxyamphetamine
(82) (2C-B);
2,5-dimethoxy-4-bromophenethylamine
(83) (2C-C);
2,5-dimethoxy-4-chlorophenethylamine
(84) (2C-D); 4-methyl-2,5-dimethoxyphenethylamine
(85) (2C-E, aquarust, cindy);
2,5-dimethoxy-4-ethylphenethylamine
(86) (2C-G);
3,4-dimethyl-2,5-dimethoxyphenethylamine
(87) (2C-I);
2,5-dimethoxy-4-iodophenethylamine
(88) (2C-T21);
2-[2,5-dimethoxy-4-(2-fluoroethylthio)phenyl]ethanamine
(89) (2C-B-FLY);
2-(8-bromo-2,3,6,7-tetrahydrofuro [2,3-f][1]benzofuran-4-yl)ethanamine
(90) Bromo-DragonFLY or 3C-Bromo-Dragonfly
or DOB-Dragonfly; 1-(4-Bromofuro[2,3-f][1]benzofuran-8-yl)propan-2-amine
(91) (DOB); 2,5-Dimethoxy-4-bromoamphetamine
(92) (DOC);
2,5-Dimethoxy-4-chloroamphetamine
(93) (DOM);
2,5-Dimethoxy-4-methylamphetamine
(94) (TMA2); 2,4,5-trimethoxyamphetamine
(95) (TMA6); 2,4,6-trimethoxyamphetamine
(96) (MDAT);
6,7-methylenedioxy-2-aminotetralin
(97) (4-acetoxy DiPT, ipracetin);
4-acetoxy-N,N-diisopropyltryptamine
(98) (4-acetoxy DMT, psilacetin;)
O-Acetylpsilocin
(99) 4-HO MET, metocin;
4-hydroxy-N-methyl-N-ethyltryptamine
(100) 4-HO MiPT, hats;
4-hydroxy-N-methyl-N-isopropyltryptamine
(101) 5-MeO-aMT, Alpha-O;
5-methoxy-α-methyltryptamine
(102) (5-MeO-MiPT);
N-[2-(5-methoxy-1H-indol-3-yl)ethyl]-N-methylpropan-2-amine
(103) (DiPT); N,N-diisopropyltryptamine
(104) (DPT); dipropyltryptamine
(105) (5-MeO-DALT); N,N-diallyl-5-methoxytryptamine
(106) (3-MeO PCP); 3-methoxyphencyclidine
(107) (4-MeO PCP); 4-methoxyphencyclidine
(108) (MK-801); dizocilpine
(109) (PCE, perchloroethylene, perchloroethene),
Perc; tetrachloroethylene
(110) (PCE, perchloroethylene, perchloroethene),
Perc; tetrachloroethylene
(111) (PCPr); phencyclamine,
N-(1-phenylcyclohexyl)propanamine
(112) (Tenocyclidine);
1-(1-(2-thienyl)cyclohexyl)piperidine
(113) (3-MeO PCE); 3-methoxyeticyclidine,
N-ethyl-1-(3-methoxyphenyl)cyclohexanamine
(114) (ETH-LAD); 6-ethyl-6-nor-lysergic acid
diethylamide
(115) (AL-LAD); 6-allyl-6-nor-LSD
(116) (PRO-LAD);
10-didehydroergoline-8-carboxamide
F. Any material, compound, mixture or preparation which
contains any quantity of the following substances.
(1) 3, 4-methylenedioxymethamphetamine
(MDMA), its optical, positional and geometric isomers, salts and salts of
isomers;
(2) (MPPP);
1-methyl-4-phenyl-4-proprionoxypiperidine its optical isomers, salts, and salts
of isomers;
(3) 1-(-2-phenylethyl)-4-phenyl-4-acetoxy
piperidine (PEPAP), its optical isomers, salts and salts of isomers;
(4) Cathinone
(5) Methcathinone
(6) Tianeptene
[16.19.20.65
NMAC - Rp 16 19.20.65 NMAC, 06-26-2018]
16.19.20.66 SCHEDULE II:
A. OPIOIDS: Unless specifically excepted or unless in another
schedule any of the following opioids, including its isomers, esters, ethers,
salts and salts of isomers, esters, and ethers whenever the existence of such
isomers, esters, ethers, and salts is possible within the specific chemical
designation except dextro and levopropoxyphene.
(1) Alphaprodine
(2) Anileridine
(3) Bezitramide
(4) Diphenoxylate
(5) Dihydrocodeine
(6) Dextropropoxyphene (bulk)
non-dosage form
(7) Fentanyl
(8) Isomethadone
(9) Levomethorphan
(10) Levorphanol
(11) Metazocine
(12) Methadone
(13) 4-cyano-2-dimethylamino-4,
4-diphenylbutane
(14) Moramide-Intermediate,
2-methyl-3-morpholino-1, 1-dipehyl-propane-carboxylic acid
(15) Pethidine
(16) 4-cyano-1-methyl-4-phenylpiperidine
(17) ethyl-4-phenyl-piperdine-4-carboxylate
(18) 1-methyl-4-phenylpiperidine-4-carboxylic
acid
(19) Phenazocine
(20) Piminodine
(21) Racemethorphan
(22) Racemorphan
(23) Sufentanil
(24) Carfentanil
(25) (LAAM); Levo-alphacetylmethadol
(26) Tapentadol
B. Shall
consist of the drugs and other substances, by whatever official name, common or
usual name, chemical name or brand name designated, listed in this
section. Substance, vegetable origin or
chemical synthesis. Unless specifically
exempt or unless listed in another schedule, any of the following substances
whether produced directly or indirectly by extraction from substances of
vegetable origin, or independently by means of chemical synthesis, or by a
combination of extraction and chemical synthesis.
(1) Opium
and opiate, and any salts, compound, derivative, or preparation of opium or
opiate excluding naloxone, dextrorphan, nalbuphine, naltrexone and apomorphine
but including the following:
(a) Raw opium
(b) Opium extracts
(c) Opium fluid extracts
(d) Powdered opium
(e) Granulated opium
(f) Tincture of opium
(g) Codeine
(h) Ethylmorphine
(i) Etorphine hydrochloride
(j) Hydrocodone
(k) Hydromorphone
(l) Metopon
(m) Morphine
(n) Oxycodone
(o) Oxymorphone
(p) Thebaine
(q) Alfentanil
(r) Oripavine
(2) Any salt, compound derivative,
or preparation thereof, which is chemically equivalent or identical with any of
the substances referred to in Paragraph (1) of Subsection A of 16.19.20.66
NMAC, except that these substances shall not include the isoquinoline alkaloids
of opium.
(3) Opium poppy and poppy straw.
(4) Coca leaves and any salt,
compound, derivative or preparation of coca leaves and any salt, compound,
derivative or preparation thereof which is chemically equivalent or identical
with any of these substances, except that the substances shall not include
de-cocainized coca leaves or extraction of coca leaves, which extractions do
not contain cocaine or ecgonine.
C. STIMULANTS:
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 stimulant effect on the central nervous system. (See 16.19.21 NMAC- Drug Precursors)
(1) Amphetamine, its salts, optical
isomers and salts of its optical isomers.
(2) Methamphetamine, its salts,
isomers and salts of isomers.
(3) Phenmetrazine and its salts.
(4) Methylphenidate
(5) Lisdexamfetamine
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
E. HALLUCINOGENIC SUBSTANCES:
Unless specifically exempt or unless listed in another schedule, any
material, compound, mixture or preparation, which contains any quantity of the
following hallucinogenic substances, or which contains any of 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 (for
purpose of this paragraph only, the term “isomers” includes the optical,
positional, and geometric isomers):
(1) Nabilone
(2) Phenylacetone
(P2P, benzyl methyl ketone; methyl benzyl ketone)
F. MISCELLANEOUS:
(1) Dihydroetorphine
(2) Bulk dextropropoxyphene
(3) Remifentanil
[16.19.20.66
NMAC - Rp 16 19.20.66 NMAC, 06-26-2018]
16.19.20.67 SCHEDULE III: Shall consist of drugs and other
substances, by whatever official name, common or usual name designated listed
in this section.
A. NARCOTIC
DRUGS: Unless specifically exempt or
unless listed in another schedule, any material, compound, mixture or
preparation containing limited quantities of the following narcotic drugs, or
any salts thereof.
(1) Not more than one and
eight-tenths grams of codeine per 100 milliliters or not more than 90
milligrams per dosage unit, with an equal or greater quantity of an
isoquinoline alkaloid of opium.
(2) Not more than one and
eight-tenths grams of codeine per 100 milliliters or not more than 90
milligrams per dosage units, with one or more active nonnarcotic ingredients in
recognized therapeutic amounts.
(3) Not more than 300 milligrams of
dihydrocodeinone per 100 milliliters or not more than 15 milligrams per dosage
unit, with a fourfold or greater quantity of an isoquinoline alkaloid of opium.
(4) Not more than 300 milligrams of
dihydrocodeinone per 100 milliliters or not more than 15 milligrams per dosage
unit, with one or more active, nonnarcotic ingredients in recognized
therapeutic amounts.
(5) Not more than one and
eight-tenths grams of dihydrocodeine per 100 milliliters or not more than 90
milligrams per dosage unit, with one or more active, nonnarcotic ingredients in
recognized therapeutic amounts.
(6) Not more than 300 milligrams of
ethylmorphine per 100 milliliters or not more than 15 milligrams per dosage
unit, with one or more active, nonnarcotic ingredients in recognized
therapeutic amounts.
(7) Not more than 500 milligrams of
opium per 100 milliliters or per 100 grams or not more than 25 milligrams per
dosage unit, with one or more active, nonnarcotic ingredients in recognized
therapeutic amounts.
(8) Not more than 50 milligrams of
morphine per 100 milliliters or per 100 grams, with one or more active,
nonnarcotic ingredients in recognized therapeutic amounts.
B. STIMULANTS: 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 stimulant effect on
the central nervous system.
(1) Those compounds, mixtures or
preparations in dosage unit form containing any stimulant, amphetamine, phenmetrazine
or methamphetamine previously exempt, for which the exemption was revoked by
FDA Regulation Title 21, Part 308.13, and any other drug of the quantitative
composition shown in that regulation for those drugs or which is the same
except that it contains a lesser quantity of controlled substances.
(2) Benzphetamine
(3) Phendimetrazine
(4) Chlorphentermine
(5) Clortermine
C. 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.
(1) Any compound, mixture or
preparation containing:
(a) Amobarbital
(b) Secobarbital
(c) Pentobarbital
(d) Butalbital; or any salt thereof
and one or more active medicinal ingredients which are not listed in any
schedule.
(2) Any suppository dosage form
containing:
(a) Amobarbital
(b) Secobarbital
(c) Pentobarbital; or any salt of any
of these drugs approved by the FDA for marketing only as a suppository.
(3) Any substance which contains any
quantity of a derivative of barbituric acid or any salt of a derivative of
barbituric acid.
(4) Chlorhexadol
(5) Lysergic Acid
(6) Lysergic Acid Amide
(7) Methyprylon
(8) Sulfondiethylmethane
(9) Sulfonethylmethane
(10) Sulfonmethane
(11) Telazol; Tiletamine/zolazepam
(12) Ketamine Hydrochloride
(13) Any
drug product containing gamma hydroxybutyric acid, including its salts,
isomers, and salts of isomers, for which an application is approved under
Section 505 of the Federal Food, Drug and Cosmetic Act.
(14) Embutramide
(15) Dronabinol
(synthetic) in sesame oil and encapsulated in soft gelatin capsules in a drug
product approved by the U.S. food and drug administration.
(16) Perampanel
D. MISCELLANEOUS:
(1) Nalorphine
(a narcotic drug)
(2) Buprenorphine
(3) Clenbuterol
E. ANABOLIC
STEROIDS: The term “anabolic
steroid” means any drug or hormonal substance, chemically and pharmacologically
related to testosterone (other than estrogens, progestins, and corticosteroids)
that promotes muscle growth. Unless specifically
exempt or unless listed in another schedule, any material, compound, mixture or
preparation which contains any quantity of the following substances listed in
this section:
(1) Boldenone
(2) Chloro testosterone
(3) Clostebol
(4) Dehydrochlormethyltestosterone
(5) Dihydrotestosterone
(6) Drostanolone
(7) Ethylestrenol
(8) Fluoxymesterone
(9) Formebolone
(10) Mestanolone
(11) Mesterolone
(12) Methandienone
(13) Methandranone
(14) Methandriol
(15) Methandrostenolone
(16) Methenolone
(17) Methyltrienolone
(18) Methyltestosterone
(19) Mibolerone
(20) Nandrolone
(21) Norbolethone
(22) Norethandrolone
(23) Oxandrolone
(24) Oxymesterone
(25) Oxymetholone
(26) Stanolone
(27) Sanozolol
(28) Testolactone
(29) Testosterone
(30) Trenbolone; and
(31) Any salt, ester, or isomer of a drug or
substance described or listed in this paragraph, if that salt, ester, or isomer
promotes muscle growth.
F. Exempt
anabolic steroids: Compounds, mixtures,
or preparations that contain an anabolic steroid that have been exempted by the
board from Subsection E of 16.19.20.67 NMAC, schedule III to the same extent
that the substance has been exempted from the application of the Federal
Controlled Substance Act, if the substance is listed as an exempt anabolic
steroid product under 21 C.F.R. Section 1308.34 and its subsequent amendments.
[16.19.20.67
NMAC - Rp 16 19.20.67 NMAC, 06-26-2018]
16.19.20.68 SCHEDULE IV: Shall consist of the drugs and
other substances, by whatever official name, common or usual name, chemical
name, or brand name designated, listed in this section.
A. DEPRESSANTS: Unless specifically exempt or unless listed
in another schedule, any material, compound, mixture or preparation which
contains any quantity of the following substances, 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) Alfaxalone
(2) Alprazolam
(3) Barbital
(4) Chloral Betaine
(5) Chloral Hydrate
(6) Chlordiazepoxide
(7) Clobazam
(8) Clonazepam
(9) Clorazepate
(10) Clotiazepam
(11) Diazepam
(12) Estazolam
(13) Ethchlorvynol
(14) Ethinamate
(15) Flurazepam
(16) Fospropofol
(17) Halazepam
(18) Lorazepam
(19) Mebutamate
(20) Meprobamate
(21) Methohexital
(22) Methylphenobarbital
(23) Midazolam
(24) Oxazepam
(25) Paraldehyde
(26) Petrichloral
(27) Phenobarbital
(28) Prazepam
(29) Quazepam
(30) Suvorexant
(31) Temazepam
(32) Triazolam
B. FENFLURAMINE: Any material, compound, mixture or
preparation which contains any quantity of the following substance, including
its salts, isomers (whether optical, positional, or geometric) and its salts,
or such isomers, whenever the existence of such salts, isomers, and salts of
isomers is possible: Fenfluramine.
C. LORCASERIN: Any material, compound, mixture or
preparation which contains any quantity of the following substance, including
its salts, isomers (whether optical, positional, or geometric) and its salts,
or such isomers, whenever the existence of such salts, isomers, and salts of
isomers is possible: Lorcaserin.
D. STIMULANTS: 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 stimulant effect on the central nervous system, including
its salts, isomers (whether optical, positional, or geometric) and salts of
such isomers whenever the existence of such salts, isomers and salts of isomers
is possible within the specific chemical designation:
(1) Diethylpropion
(2) Phentermine
(3) Pemoline (including
organometallic complexes and chelates thereon)
(4) Pipradrol
(5) SPA ((-)-1-dimethyl
amino-1,2-diphenylmethane)
(6) Mazindol
(7) Cathine
(8) Fencamfamin
(9) Fenproporex
(10) Mefenorex
(11) Modafinil
(12) Sibutramine
E. OTHER
SUBSTANCES: Unless specifically
exempt or unless listed in another schedule, any material, compound, mixture or
preparation which contains any quantity of the following substances, including
its salts:
(1) Dextropropoxyphene(Alpha-(+)-4-dimethylamino-1,2-diphenyl-3-methyl-2-propionoxybutane)
(2) Pentazocine
(3) Carisoprodol
(4) Nalbuphine Hydrochloride
(5) Butorphanol Tartrate
(6) Dezocine
(7) Dichloralphenazone
(8) Zaleplon
(9) Zolpidem
(10) Eszopiclone
(11) Tramadol
(12) Eluxadoline
(5-[[[(2S)-2-amino-3-[4-aminocarbonyl)-2,6-dimethylphenyl]-1-oxopropyl][(1S)-1-(4-phenyl-1H-imidazol-2-yl)ethyl]amino]methyl]-2-methoxybenzoic
acid) (including its optical isomers) and its salts, isomers, and salts of
isomers.
F. NARCOTIC
DRUG: Unless specifically exempt or
unless listed in another schedule, any material, compound, mixture or
preparation containing limited quantities of any of the following narcotic
drugs or any salts thereof: Not more
than one milligram of difenoxin and not less than 25 micrograms of atropine
sulfate per dosage unit.
G. EXEMPTION
OF CHLORAL: When packaged in a
sealed, oxygen-free environment, under nitrogen pressure, safeguarded against
exposure to the air. Chloral when
existing under the above conditions is a substance which is not intended for
general administration to a human being or another animal, and contains no
narcotic controlled substances and is packaged in such a form that the package
quantity does not present any significant potential for abuse. All persons who engage in industrial
activities with respect to such chloral are subject to registration; but shall
be exempt from Section 30-31-16 through 19 of the New Mexico Controlled
Substances Act and 16.19.20.19 NMAC through 16.19.20.52 NMAC of the board of
pharmacy regulations.
H. EXEMPT
COMPOUNDS: Librax and Menrium are
preparations which contain chlordiazepoxide, a depressant listed in schedule
IV, Paragraph (6) of Subsection A of 16.19.20.68 NMAC and other ingredients in
such combinations, quantity, preparation or concentration as to vitiate the
potential for abuse of chlordiazepoxide, and are hereby exempt preparations.
(1) Librax
(2) Menrium, 5-2
(3) Menrium, 4-5
(4) Menrium, 10-4
[16.19.20.68
NMAC - Rp 16 19.20.68 NMAC, 06-26-2018]
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]
[16.19.20.69
NMAC - Rp 16 19.20.69 NMAC, 06-26-2018]
16.19.20.70 EXEMPT DANGEROUS DRUGS (PRESCRIPTION
STATUS DRUGS): The drugs set forth
in the Federal DEA Table of Excepted
Prescription Drugs published in a separate volume under Code of Federal
Regulations, Title 21, Chapter II, Part 1308.32 have been exempt by the New
Mexico board of pharmacy. Any deviation
from the quantitative composition of any of the listed drugs shall require a
petition for exemption to the Federal DEA in order that a drug may be exempt by
DEA and the New Mexico board of pharmacy.
[16.19.20.70
NMAC - Rp 16.19.20.70 NMAC, 06-26-2018]
History of 16.19.20 NMAC:
Pre-NMAC History:
Material
in this part was derived from that previously filed with the commission of
public records - state records center and archives as:
BOP
69-2, Rules and Regulations of the State Board of Pharmacy, filed 06-13-69;
BOP
69-3, New Mexico Laws and Regulations, Pharmacy Act, Drug and Cosmetic Act,
Narcotic Drug Act, Poisons Act, Board of Pharmacy Rules and Regulations, filed
08-15-69;
BOP
72-1, New Mexico Board of Pharmacy Rules and Regulations Promulgated Pursuant
to New Mexico Drug and Cosmetic Act, Pharmacy Act, Controlled Substances Act,
filed 04-01-69;
Regulation
No. 20, Controlled Substances, filed 02-07-80;
Regulation
No. 20, Controlled Substances, filed 10-24-85;
Regulation
No. 20, Controlled Substances, filed 02-02-87;
Regulation
No. 20, Controlled Substances, filed 07-27-90.
History
of Repealed Material:
85-1,
Repealer, filed 10-29-85.
16
NMAC 19.20, Pharmacists - Controlled Substances, filed 05-01-98, repealed effective 07-15-2002.
16.19.20
NMAC, Controlled Substances, filed 07-15-2002, repealed effective 06-26-2018.
Other History:
Regulation
No. 20, Controlled Substances, filed 07-27-90; renumbered, reformatted to 16
NMAC 16.4, Pharmacists - Controlled Substances, filed 02-02-96;
16
NMAC 19.20, Pharmacists - Controlled Substances, filed 07-25-96;
16
NMAC 19.20, Pharmacists - Controlled Substances, filed 05-01-98;
16
NMAC 19.20, Pharmacists - Controlled Substances, filed 05-01-98, replaced by 16.19.20 NMAC, Controlled
Substances, effective 07-15-2002.