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, Albuquerque, NM.
[16.19.20.1 NMAC - Rp 16 NMAC 19.20.1, 07-15-02; A,
12-15-02; A, 03-07-11]
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 NMAC 19.20.2, 07-15-02]
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 NMAC 19.20.3, 07-15-02]
16.19.20.4 DURATION: Permanent.
[16.19.20.4 NMAC - Rp 16 NMAC 19.20.4, 07-15-02]
16.19.20.5 EFFECTIVE
DATE: July 15, 2002, unless a
different date is cited at the end of a Section.
[16.19.20.5 NMAC -
Rp 16 NMAC 19.20.5, 07-15-02]
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 NMAC 19.20.6, 07-15-02]
16.19.20.7 DEFINITIONS: (Reserved)
[16.19.20.7 NMAC -
Rp 16 NMAC 19.20.7, 07-15-02]
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;
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 D.E.A., 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 NMAC 19.20.8, 07-15-02; A,
12-15-02; A, 07-15-2004; A, 05-14-10]
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 NMAC 19.20.8(1), 07-15-02]
16.19.20.10 REGISTRATION
FEE:
A. The registration fee or annual
renewal fee required by the Controlled Substances Act shall be $60.00 for
registrants.
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 NMAC 19.20.9, 07-15-02]
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 NMAC 19.20.10, 07-15-02]
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 NMAC 19.20.10(1), 07-15-02]
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, physicians office where controlled substances are prescribed but not administered or otherwise dispensed.
[16.19.20.13 NMAC - Rp 16 NMAC 19.20.10(2), 07-15-02]
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/or professional license, and shall be signed by the applicant.
[16.19.20.14 NMAC -
Rp 16 NMAC 19.20.10(3), 07-15-02]
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 NMAC 19.20.10(4), 07-15-02]
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 NMAC 19.20.10(5), 07-15-02]
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 NMAC 19.20.10(6), 07-15-02]
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 NMAC 19.20.11, 07-15-02]
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 and/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 NMAC 19.20.12, 07-15-02]
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 6 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 (4) days from the annual inventory date.
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.
[16.19.20.20 NMAC - Rp 16 NMAC 19.20.13, 07-15-02]
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 NMAC 19.20.13(1), 07-15-02]
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 NMAC 19.20.13(2), 07-15-02]
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 NMAC 19.20.13(3), 07-15-02]
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 NMAC 19.20.13(4), 07-15-02]
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 NMAC 19.20.13(5), 07-15-02]
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 (6) 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 NMAC 19.20.14, 07-15-02]
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 NMAC 19.20.14(1), 07-15-02]
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 NMAC 19.20.14(2), 07-15-02]
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 NMAC 19.20.14(3), 07-15-02]
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 NMAC 19.20.15, 07-15-02]
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” 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 NMAC 19.20.15(1), 07-15-02; A, 01-31-07]
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 NMAC 19.20.15(2), 07-15-02]
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 NMAC 19.20.15(3), 07-15-02]
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 NMAC 19.20.15(4), 07-15-02]
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 NMAC 19.20.15(5), 07-15-02]
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 (5) 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 NMAC 19.20.16, 07-15-02]
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 NMAC 19.20.16(1), 07-15-02]
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 NMAC 19.20.17, 07-15-02]
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/or 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 NMAC 19.20.18, 07-15-02]
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 NMAC 19.20.19, 07-15-02]
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 NMAC 19.20.20, 07-15-02]
16.19.20.42 PRESCRIPTION
REQUIREMENTS:
A. Prescriptions for controlled substances shall be dated and signed as of the date of issue, and shall contain the full name and address of the patient, the name, address and federal registration number of the prescribing practitioner. Prescriptions for controlled substances listed in schedule II shall be written in ink, indelible pencil, or typewritten and manually signed by the practitioner.
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.
G. A pharmacy employee must verify the identity of the patient or the
patient’s representative before a new prescription for a controlled substance
listed in schedule II, III, or IV, is delivered. Acceptable identification means a state
issued driver’s license, including photo, or other government issued photo
identification. The identification
number of the government issued identification and the name imprinted on that
identification must be recorded in a manner to be determined by a written
policy developed by the pharmacist-in-charge.
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 NMAC 19.20(1), 07-15-02; A, 01-15-08]
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 NMAC 19.20.20(2), 07-15-02]
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 NMAC 19.20.20(3), 07-15-02]
16.19.20.45 PRESCRIPTION
REFILL REQUIREMENTS:
A. Prescriptions for Schedule III
or IV substances shall not be filled or refilled more than six (6) months after
the date of issue or be refilled more than five (5) times unless renewed by the
practitioner and a new prescription is placed in the pharmacy files.
B. Schedule V prescriptions may be
refilled only as expressly authorized by the prescribing physician on the
prescription. If no such authorization
is given, the prescription may not be refilled.
[16.19.20.45 NMAC - Rp 16 NMAC 19.20.20(4), 07-15-02]
16.19.20.46 PRESCRIPTION
- PARTIALLY REFILLED:
A. A Schedule II prescription may
be partially filled if the amount is recorded on the prescription. The remaining portion may be filled within 72
hours of the partial filling. Pharmacist
must notify the prescribing physician if remaining portion cannot be filled
within a 72 hour period.
B. 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 (6) months from
date of prescription.
C. 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 NMAC 19.20.20(5), 07-15-02]
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 7 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 7 days period, the pharmacist shall notify the nearest DEA office,
and the Board of Pharmacy.
[16.19.20.47 NMAC -
Rp 16 NMAC 19.20.20(6), 07-15-02]
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/or 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 NMAC 19.20.21, 07-15-02]
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 NMAC 19.20.21(1), 07-15-02]
16.19.20.50 PHARMACIES,
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 NMAC 19.20.21(2), 07-15-02]
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 NMAC 19.20.21(3), 07-15-02]
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 NMAC 19.20.21(4), 07-15-02]
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 (8) 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 (4) 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
br 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 3.6 grams per day or more than a total
of 9 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 3.6 grams
today or more than a total of 9 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.
[16.19.20.53 NMAC -
Rp 16 NMAC 19.20.22, 07-15-02; A, 06-30-06]
16.19.20.54 EXEMPTED OVER-THE-COUNTER DRUGS: (Information published by D.E.A.)
[16.19.20.54 NMAC - Rp 16 NMAC 19.20.23, 07-15-02]
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 NMAC 19.20.24, 07-15-02]
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 NMAC 19.20.25, 07-15-02]
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 NMAC 19.20.26, 07-15-02]
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 NMAC 19.20.26(1), 07-15-02]
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 NMAC 19.20.26(2), 07-15-02]
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 NMAC 19.20.26(3), 07-15-02]
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 NMAC 19.20.26(4), 07-15-02]
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 NMAC 19.20.26(5), 07-15-02]
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, Controlled Substances Act.
[16.19.20.63 NMAC -
Rp 16 NMAC 19.20.26(6), 07-15-02]
16.19.20.64 CONTROLLED
SUBSTANCE PRECURSORS: See 16.19.21 NMAC - Drug Precursors
[16.19.20.64 NMAC - Rp 16 NMAC 19.20.27, 07-15-02]
16.19.20.65 SCHEDULE
I:
A. NMSA 1978 Section 30-31-6
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; OPIATES,
unless specifically exempt or unless listed in another schedule, any of the
following opiates, 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) Dextromoramide
(14) Diampromide
(15) Diethylthiambutene
(16) Dimethylthiambutene
(17) Difenoxin
(18) Dimenoxadol
(19) Dimepheptanol
(20) Dimethylthiambutene
(21) Dioxaphetyl Butyrate
(22) Dipipanone
(23) Ethylmethylthiambutene
(24) Etonitazene
(25) Etoxeridine
(26) Furethidine
(27) Hydroxypethidine
(28) Ketobemidone
(29) Levomoramide
(30) Levophenacylmorphan
(31) Morpheridine
(32) Noracymethadol
(33) Norlevorphanol
(34) Normethadone
(35) Norpipanone
(36) Phenadoxone
(37) Phenampromide
(38) Phenomorphan
(39) Phenoperidine
(40) Piritramide
(41) Proheptazine
(42) Properidine
(43) Propiram
(44) Racemoramide
(45) Tilidine
(46) Trimeperidine
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) Beta-Hydroxy-3-Methylfentanyl
(25) 3-Methylthiofentanyl
(26) Acetyl-Alpha-Methyl fentanyl
(27) Alpha-Methylthiofentanyl
(28) Beta-hydroxfentanyl
(29) Para-Fluoro fentanyl
(30) Thiofentanyl
C. 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 position, and geometric isomers).
(1) 3,4 -methylenedioxy amphetamine
(2) 5 - methoxy - 3,4-methylenedioxy amphetamine
(3) 3,4,5 -trimethoxy amphetamine
(4) Bufotenine
(5) Diethyltryptamine; DET
(6) Dimethyltryptamine; DMT
(7) 4-methyl-2,5-dimethoxy-amphetamine; DOM or STP
(8) Lysergic acid diethylamide
(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) 4-methoxyamphetamine; PMA
(23) Ethylamine N-ethyl-1-phenylcyclohexylamine (PCE)
(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) 2,.5
dimethoxy-4-(n)-propylthiophenethylamine (2C-T-7)
(30) Alpha-methyltryptamine (AMT)
(31) 5-methoxy-N,N-diisopropyltryptamine
(5-MeO-DIPT)
(32) Synthetic cannabinoids: Unless specifically exempted or unless listed
in another schedule, any material, compound, mixture of 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:
(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)
(33) Substances determined by the board to have the pharmacological effect of the substance,
the risk to the public health by abuseof the substance and the potential of the substance to produce psychic
or physiological dependence liability is similar to thesubstances 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)
(34) 4-methyl-ethylcathinone (4-MEC)
(35) 4-ethyl-methcathinone (4-EMC)
(36) 2-ethylamino-1-phenyl-propan-1-one (ethcathinone)
(37) 3’,4’-methylenedioxyethcathinone (ethylone)
(38) beta-keto-N-methyl-3,4-benzodioxyolybutanamine (bk-MBDB, butylone)
(39) naphthylpyrovalerone (NRG-1, naphyrone)
(40) N,N-dimethylcathinone (metamfepramone)
(41) alpha-pyrrolidinopropiophenone (alpha-PPP)
(42) alpha-pyrrolidinobutiophenone (α-PBP)
(43) 4’-methoxy-alpha-pyrrolidinopropiophenone (MOPPP)
(44) 4’-methyl-α-pyrrolidinopropiophenone (MPPP)
(45) 3’,4’-methylenedioxy-alpha-pyrrolidinopropiophenone (MDPPP)
(46) 3’,4’-methylenedioxy-alpha-pyrrolidinobutiophenone (MDPBP)
(47) 4’-methyl-α-pyrrolidinobutiophenone
(MPBP)
(48) alpha-pyrrolidinovalerophenone (alpha-PVP)
(49) 5,6-methylenedioxy-2-aminoindane (MDAI)
(50) alpha-methylamino-butyrophenone
(buphedrone)
(51) beta-keto-ethylbenzodioxolylbutanamine
(eutylone)
(52) beta-keto-ethylbenzodioxolylpentanamine
(pentylone)
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
(b) camazepam
(c) clobazam
(d) cloxazolam
(e) delorazepam
(f) ethylloflazepate
(g) fludiazepam
(h) flunitrazepam
(i) haloxazolam
(j) ketazolam
(k) loprazolam
(l) lormetazepam
(m) medazepam
(n) nimetazepam
(o) nitrazepam
(p) nordiazepam
(q) oxazolam
(r) pinazepam
(s) tetrazepam
(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.
E. 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) N-benzylpiperazine (BZP,
1-benzylpiperazine)
F. Any material, compound, mixture of preparation which contains any quantity of the following substances.
(1) 3-Methylfentanyl(N-3-methyl-1-(2-phenyl-ethyl)-4-Piperidyl)-N-phenylpropanamide, its’ optical and geometric isomers, salts and salts of isomers.
(2) 3, 4-methylenedioxymethamphetamine (MDMA), its’ optical, positional and geometric isomers, salts and salts of isomers.
(3) 1-methyl-4-phenyl-4-proprionoxypiperidine (MPPP), its’ optical isomers, salts, and salts of isomers.
(4) 1-(-2-phenylethyl)-4-phenyl-4-acetoxy piperidine (PEPAP), its’ optical isomers, salts and salts of isomers.
(5) Cathinone.
(6) Methcathinone.
[16.19.20.65 NMAC - Rp 16 NMAC 19.20.28, 07-15-02; A, 06-30-05; A, 01-15-08; A, 05-14-10; A, 11-27-11]
16.19.20.66 SCHEDULE
II:
A. 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 16.19.20.66.A.(1) 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.
B. OPIATES: Unless specifically excepted or unless in
another schedule any of the following opiates, 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 dextrose 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) Methadone-Intermediate
(14) Monamide-Intermediate
(15) Pethidine
(16) Pethidine-Intermediate A
(17) Pethidine-Intermediate B
(18) Pethidine-Intermediate C
(19) Phenazocine
(20) Piminodine
(21) Racemethorphan
(22) Racemorphan
(23) Sufentanil
(24) Carfentanil
(25) Levo-alphacetylmethadol (LAAM)
(26) Tapentadol
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) Dronabinol (synthetic) - in sesame oil and encapsulated in soft gelatin capsules in a drug product approved by the U.S. food and drug administration
(6) Glutethimide
(7) 1-phenylcyclohexylamine
(8) 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 position, and geometric isomers): Nabilone
F. MISCELLANEOUS:
(1) Dihydroetorphine
(2) Bulk dextropropoxyphene
(3) Remifentanil
[16.19.20.66 NMAC - Rp 16 NMAC 19.20.28(1), 07-15-02; A, 06-30-05; A, 01-15-08; A, 05-14-10]
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. 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.
B. 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) Tiletamine/zolazepam (Telazol)
(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
C. Nalorphine (a narcotic drug).
D. Buprenorphine.
E. 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 1.8 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 1.8 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 1.8 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.
F. 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) stanozolol
(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.
G. 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 NMAC 19.20.28(2), 07-15-02; A, 02-15-03; A, 06-30-05; A, 01-31-07; A,
01-15-08; A, 05-14-10]
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) Alprazolam
(2) Barbital
(3) Chloral Betaine
(4) Chloral Hydrate
(5) Chlordiazepoxide
(6) Clonazepam
(7) Clorazepate
(8) Clotiazepam
(9) Diazepam
(10) Estazolam
(11) Ethchlorvynol
(12) Ethinamate
(13) Flurazepam
(14) Halazepam
(15) Lorazepam
(16) Mebutamate
(17) Meprobamate
(18) Methohexital
(19) Methylphenobarbital
(20) Midazolam
(21) Oxazepam
(22) Paraldehyde
(23) Petrichloral
(24) Phenobarbital
(25) Prazepam
(26) Quazepam
(27) Temazepam
(28) Triazolam
(29)
Zopiclone
B. FENFLURAMINE: Any material, compound, mixture or preparation which contains any quantity of the following substance, including its’ salts, isomers (whether optical position, or geometric) and its’ salts, or such isomers, whenever the existence of such salts, isomers, and salts of isomers is possible: Fenfluramine
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, including its’ salts, isomers (whether optical position, 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
D. 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) Tramadol
E. 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 1 milligram of difenoxin and not less than 25 micrograms of atropine sulfate per dosage unit.
F. 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.
G. EXEMPT COMPOUNDS: Librax and Menrium are preparations which contain chlordiazepoxide, a depressant listed in Schedule IV, 16.19.20.68.A.5 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 NMAC 19.20.28(3), 07-15-02; A, 06-30-05; A, 05-14-10; A, 03-07-11]
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 2.5 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 0.5 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]
[16.19.20.69 NMAC - Rp 16 NMAC 19.20.28(4), 07-15-02; A, 06-30-05; A, 06-30-06; A, 01-31-07; A, 05-14-10]
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 NMAC 19.20.28(5), 07-15-02]
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.
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.