New Mexico Administrative Code
Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING
Chapter 19 - PHARMACISTS
Part 10 - LIMITED DRUG CLINICS
Section 16.19.10.11 - PUBLIC HEALTH CLINICS
Universal Citation: 16 NM Admin Code 16.19.10.11
Current through Register Vol. 35, No. 18, September 24, 2024
A. Clinic Licensure: All clinics where dangerous drugs are administered, distributed or dispensed shall obtain a limited drug permit as described in Paragraph (7) of Subsection B of Section 61-11-14 NMSA 1978 of the Pharmacy Act which consists of the following types:
(1) Class A clinic drug permit for clinics
where:
(a) dangerous drugs are administered
to patients of the clinic;
(b) more
than 12,500 dispensing units of dangerous drugs are dispensed or distributed
annually;
(c) clinics dispensing
only one class of dangerous drug or controlled substance, such as oral
contraceptives, may be approved by the board as a Class B3 clinic;
(2) Class B clinic drug permit for
clinics where dangerous drugs are:
(a)
administered to patients of the clinic; and
(b) dispensed or distributed to patients of
the clinic. Class B drug permits shall be issued by categories based on the
number of dispensing units of dangerous drugs to be dispensed or distributed
annually, as follows:
1. CATEGORY 1 up to
2,500 dispensing units;
2. CATEGORY
2 from 2,501 - 7,500 dispensing units;
3. CATEGORY 3 from 7,501 - 12,500 dispensing
units;
(3)
Class C clinic drug permit for clinics where dangerous drugs are administered
to patients of the clinic.
(4)
Class D clinic drug permit for school based emergency medicine (SBEM) clinic
(which does not include a Class A, B, or C school based health clinic) - any
school based facility that chooses to possess a stock supply of emergency
dangerous drugs; these emergency dangerous drugs are albuterol aerosol
canisters with spacers and epinephrine standard-dose and pediatric-dose
auto-injectors; these emergency dangerous drugs are for administration to
students of the school; these emergency dangerous drugs shall be the property
of the facility; these facilities will not stock of any other dangerous
drug.
(5) Class E Narcotic
Treatment Program (NTP) clinic drug permit for clinics where opioid agonist
treatment medications that are approved by the Food and Drug Administration
under section 505 of the Federal Food, Drug, and Cosmetic Act [ (21 U.S.C.
355) ] for use in the treatment of opioid use
disorder are used. An NTP shall be licensed and certified as required by state
and federal law, including registration under
21 USC
823(g)(1) and certified as
an Opioid Treatment Program by the Substance Abuse and Mental Health Services
Administration in accordance with
42 CFR
8.11.
B. Formularies:
(1) For all clinic types, drug procurement
and storage is limited to the drugs listed in the dispensing formulary for the
clinic. The formulary shall be developed by the pharmacy and therapeutics
committee of the facility, or if no such committee exists, by the pharmacist
and medical director of the clinic. The formulary drugs shall be appropriate
for the scope of medical services provided at the clinic facility. A dangerous
drug with the same generic name is considered one drug within the formulary
(ie) all dosage forms and packages of ampicillin are considered one
drug.
(2) For all clinic types,
drug procurement and storage is limited to the drugs listed in the
administration formulary for on-site administration. The formulary shall be
developed by the pharmacy and therapeutics committee of the facility, or if no
such committee exists, by the pharmacist and medical director of the clinic.
The formulary drugs shall be appropriate for the scope of medical services
provided at the clinic facility. A dangerous drug with the same generic name is
considered one drug within the formulary (ie) all dosage forms and packages of
ampicillin are considered one drug.
(3) For Class D, (SBEM) clinic may only stock
the approved dangerous drugs; albuterol aerosol canisters with spacers and
epinephrine standard-dose and pediatric-dose auto-injectors.
(4) A clinic may petition the board for an
alternative dispensing formulary as set forth in Subsection R of
16.19.10.11 NMAC.
C. Consultant Pharmacist:
(1) Any facility licensed as a clinic by the
board which does not employ a staff pharmacist must engage the services of a
consultant pharmacist, whose duties and responsibilities are described in
Subsection C of
16.19.4.11 NMAC.
(2) The consultant pharmacist shall wear an
identification badge listing his name and job title while on duty in the
clinic.
D. Pharmacy Technicians and Support Personnel:
(1)
Pharmacy technicians, working in a clinic under the supervision of the
pharmacist, may perform activities associated with the preparation and
distribution of medications, including prepackaging medications and the filling
of a prescription or medication order. These activities may include counting,
pouring, labeling and reconstituting medications.
(2) The pharmacist shall ensure that the
pharmacy technician has completed the initial training required in Subsection A
of 16.19.22.9 NMAC.
(3) A written record of the initial training
and education will be maintained by the clinic pursuant to requirements of
Subsection C of
16.19.22.9 NMAC.
(4) The permissible ratio of pharmacy
technicians to pharmacists on duty is to be determined by the pharmacist in
charge or consultant pharmacist.
(5) Support personnel may perform clerical
duties associated with clinic pharmacy operations, including computer data
entry, typing of labels, processing of orders for stock, duties associated with
maintenance of inventory and dispensing records.
(6) The pharmacist is responsible for the
actions of personnel; allowing actions outside the limits of the regulations
shall constitute unprofessional conduct on the part of the
pharmacist.
(7) Name tags including
job title, shall be required of all personnel while on duty in the
clinic.
E. Procurement or Receipt of Dangerous Drugs:
(1) The system
of procurement for all drugs shall be the responsibility of the
pharmacist.
(2) Records of receipt
of dangerous drugs and inventories of controlled substances shall be maintained
as required by the Drug, Device and Cosmetic Act 26-1-16 and the Controlled
Substances Act 30-31-16 and board of pharmacy regulation 16.19.20
NMAC.
F. Repackaging:
(1) Repackaging from bulk containers to
dispensing units for distribution at locations other than the site of
repackaging requires FDA registration, whether or not the repackaged drugs
enter interstate commerce. (See FDA Regulations Title 21, Sections 207, 210 and
211).
(2) Repackaging of drug from
bulk containers into multiple dispensing units for future distribution to
clinic patients at the site of repackaging may be done by a physician, dentist,
pharmacist, or by a pharmacy technician under the supervision of the pharmacist
as defined in Subsection B of
16.19.22.7 NMAC. All drugs
repackaged into multiple dispensing units by a pharmacy technician must undergo
a final check by the pharmacist.
(3) A record of drugs repackaged must be
maintained, to include the following.
(a)
Date of repackaging.
(b) Name and
strength of drug.
(c) Lot number or
control number.
(d) Name of drug
manufacturer.
(e) Expiration date
(per USP requirements).
(f) Total
number of dosage units (tabs, caps) repackaged (for each drug).
(g) Quantity per each repackaged unit
container.
(h) Number of dosage
units (tabs, caps) wasted.
(i)
Initials of repackager.
(j)
Initials of person performing final check.
(4) All dispensing units of repackaged
medication must be labeled with the following information.
(a) Name, strength, and quantity of the
drug.
(b) Lot number or control
number.
(c) Name of
manufacturer.
(d) Expiration
date.
(e) Date drug was
repackaged.
(f) Name or initials of
repackager.
(g) Federal caution
label, if applicable.
(5) Repackaged units must be stored with the
manufacturer's package insert until relabeled for dispensing. as specified
under Subsection G of
16.19.10.11 NMAC.
G. Clinic Dispensing or Distributing:
(1) Drugs shall be dispensed or
distributed only to clinic patients on the order of a licensed practitioner of
the clinic.
(2) The clinic
practitioner shall record the prescribed drug therapy on the patient medical
record indicating the name, strength, quantity and directions for use of the
prescribed drug. This information shall be initialed or signed by the
practitioner. A separate prescription form in addition to the medical record
may be used.
(3) The prescription
order may then be prepared by the practitioner, pharmacist or technician under
the supervision of the pharmacist and a dispensing label affixed to the
dispensing unit of each drug. The following information shall appear on the
label affixed to the dispensing unit.
(a) Name
of patient.
(b) Name of
prescriber.
(c) Date of
dispensing.
(d) Directions for
use.
(e) Name, strength, and
quantity of the drug.
(f)
Expiration date.
(g) Name, address
and phone number of the clinic.
(h)
Prescription number, if applicable.
(4) The pharmacist or practitioner must then
provide a final check of the dispensing unit and sign or initial the
prescription or dispensing record.
(5) Refill prescription orders must also be
entered on the patient's medical record and the dispensing record.
H. Patient Counseling:
(1) Each clinic licensed by the board shall
develop and provide to the board policies and procedures addressing patient
counseling which are at least equivalent to the requirements of Subsection F of
16.19.4.16 NMAC.
(2) If the consultant pharmacist is absent at
the time of dispensing or distribution of a prescription from clinic drug stock
to a clinic patient, the patient shall be provided written information when
appropriate on side effects, interactions, and precautions concerning the drug
or device provided. Alternative forms of patient information may be used to
supplement patient counseling when appropriate. Examples include, but not
limited to, written information leaflets, pictogram labels and video programs.
The clinic shall make the consultant pharmacist's phone number available to
patients for consultation on drugs provided by the clinic.
I. Dispensing Records: A record shall be kept of the dangerous drugs dispensed indicating the date the drug was dispensed, name and address of the patient, the name of the prescriber, and the quantity and strength of the drug dispensed. The individual recording the information and the pharmacist or clinic practitioner who is responsible for dispensing the medication shall initial the record.
J. Sample Drugs: Samples of medications which are legend drugs or which have been restricted to the sale on prescription by the New Mexico board of pharmacy are subject to all the record keeping, storage and labeling requirements for prescription drugs as defined by Section 26-1-16 NMSA 1978 and other applicable state and federal laws.
K. Drug Storage:
(1) Space for the storage and dispensing of
drugs shall have proper ventilation, lighting, temperature controls,
refrigeration and adequate security as defined by the board or its' agent.
Minimum space requirements for main drug storage areas are as follows:
(a) for Class A clinics - 240 square foot
room;
(b) for Class B clinics;
(i) categories 1, and 2 - 48 square foot
room; and
(ii) category 3 - 96
square foot room;
(c)
for Class C clinics - an area adequate for the formulary.
(d) for Class D clinics - an area adequate
for the formulary:
(i) medication is stored
in its original packaging until the time of administration, and secured in a
secondary tamper-evident container;
(ii) the dangerous drug is stored in a
restricted area, secure but unlocked, and readily accessible to authorized,
trained personnel;
(iii) for Class
D clinics only, the pre-licensing inspection may be completed by a New Mexico
board of pharmacy state drug inspector's approval of record keeping procedures;
the policy and procedure manual; any other required forms or documents; and
photographs of the proposed dangerous drug storage area, secondary
tamper-evident container, and drug storage area thermometer; this pre-licensing
inspection may not require an onsite inspection.
(e) for Class E clinics - 96 square foot
room.
(2) Controlled
substances must be stored as defined in
16.19.20.48 NMAC.
(3) All drug containers in the facility shall
be clearly and legibly labeled as required under Subsection F of
16.19.10.11 NMAC - (REPACKAGING
and Sections
26-1-10 and
26-1-11 of the Drug, Device and
Cosmetic Act).
(4) Purchase,
storage and control of drugs shall be designed to prevent having outdated,
deteriorated, impure or improperly standardized drugs in the
facility.
(5) Access to the drug
storage area shall be limited to clinic practitioners, the pharmacist, and
supportive personnel who are performing pharmacy-related functions.
(6) Clinics licensed by the board prior to
adoption of this regulation are exempt from the minimum space requirements set
forth in Paragraph (1) of Subsection K of
16.19.10.11 NMAC. When these
facilities change ownership, remodel the drug storage area, or relocate after
May 15, 1996, the requirements of Paragraph (1) of Subsection K of
16.19.10.11 NMAC shall
apply.
L. Dispositon of Unwanted or Outdated Drugs:
(1) The pharmacist
shall be responsible for removal of recalled, outdated, unwanted or otherwise
unusable drugs from the clinic inventory.
(2) Options for disposal are destruction
under the supervision of the pharmacist or return to the legitimate source of
supply. Controlled substance disposition shall occur in accordance with
16.19.20.38 NMAC.
M. Reference Material: Adequate reference materials are to be maintained in the clinic. These shall include a current product information reference such as USPDI, facts and comparisons, or American hospital formulary service; a copy of the state drug laws and regulations and a poison treatment chart with the regional poison control center's telephone number.
N. Procedures Manual:
(1) Written policies and
procedures shall be developed by the pharmacy and therapeutics committee, or if
none, by the pharmacist-in-charge and clinic's executive director, and
implemented by the pharmacist-in-charge.
(2) The policy and procedure manual shall
include but not be limited to the following:
(a) a current list of the names and addresses
of the pharmacist-in-charge, consultant-pharmacist, staff pharmacist(s),
supportive personnel designated to provide drugs and devices, and the
supportive personnel designated to supervise the day-to-day pharmacy related
operations of the clinic in the absence of the pharmacist;
(b) functions of the pharmacist-in-charge,
consultant pharmacist, staff pharmacist(s) and supportive personnel;
(c) clinic objectives;
(d) formularies;
(e) a copy of the written agreement, if any,
between the pharmacist and the clinic;
(f) date of the last review or revision of
policy and procedure manual; and
(g) policies and procedures for
(i) security;
(ii) equipment;
(iii) sanitation;
(iv) licensing;
(v) reference materials;
(vi) drug storage;
(vii) packaging and repackaging;
(viii) dispensing and distributing;
(ix) supervision;
(x) labeling and relabeling;
(xi) samples;
(xii) drug destruction and returns;
(xiii) drug and device procuring;
(xiv) receiving of drugs and
devices;
(xv) delivery of drugs and
devices;
(xvi) record keeping;
and
(xvii) scope of
practice.
(3)
The procedures manual shall be reviewed on at least an annual basis. A copy of
the manual shall be kept at the clinic at all times.
(4) A written agreement defining specific
procedures for the transfer, storage, dispensing and record keeping of clinic
dangerous drug stock from a licensed New Mexico pharmacy will be included in
the procedures manual. The agreement will be signed by a clinic official and
pharmacy official and reviewed annually.
O. Patient Record: clinics shall maintain patient records as defined in Subsection C of 16.19.4.16 NMAC.
P. Drug Transfer to a Pharmacy:
(1) Dangerous drug stock unopened containers,
except samples, may be transferred physically or electronically to a pharmacy
licensed in New Mexico for dispensing to clinic patients.
(a) record of transfer shall be maintained at
the clinic and the pharmacy. It will include:
(i) date of transfer or shipment;
(ii) name and strength of drug;
(iii) package size;
(iv) number of packages;
(v) manufacturer or repackager; and
(vi) lot number and expiration date, unless
transferred from a clinic supplier to a pharmacy.
(b) A copy of the transfer or shipment record
will be provided to the pharmacy at the time of transfer. This record will be
compared with the drugs for accuracy and retained by the pharmacy as the
receipt document separate from other receiving records of the
pharmacy.
(c) Transferred clinic
drugs will be stored in the restricted area of the pharmacy and physically
separated from all other pharmacy drugs.
(d) Drugs returned to the clinic by the
pharmacy will be documented in a transfer record as described in Subparagraph
(a) of Paragraph (1) of Subsection P of
16.19.10.11 NMAC. A copy will be
maintained by the pharmacy and the clinic.
(2) A clinic may petition the board for an
alternative drug transfer system as set forth in Subsection Q of
16.19.10.11 NMAC.
(3) The formulary of transferred drugs for
pharmacy dispensing is restricted to the clinic's scope of practice.
Q. Pharmacy Dispensing: Clinic drug stock may be transferred to, and maintained by, a pharmacy for dispensing to clinic patients as provided in this regulation. Clinic drug stock may be dispensed by the pharmacy if:
(1) the drugs
are dispensed only to a clinic patient with a valid prescription from a
practitioner of that clinic;
(2)
clinic prescriptions for clinic drugs are maintained separately from other
prescriptions of the pharmacy;
(3)
the prescription is dispensed in a container with a label attached which reads
"DISPENSED FOR (clinic name and address) BY (pharmacy name and
address)";
(4) all packaging and
labeling requirements for prescriptions dispensed by a pharmacy have been met;
and
(5) patient records and
counseling requirements have been maintained separately for all clinic patients
whose prescriptions were filled by the pharmacy from clinic drug
stock.
R. Petition for Alternative Plan:
(1) A clinic may petition
the board for an alternative visitation schedule, dispensing formulary, or drug
transfer system (each an "alternative plan") as follows.
(a) Prior to implementation of any
alternative plan, the clinic shall provide to the board a written petition that
describes the proposed alternative plan and justifies the request. The petition
shall include an affidavit that states that the clinic has a current policy and
procedures manual on file, has adequate security to prevent diversion of
dangerous drugs, and is in compliance with all rules applicable to the clinic.
The affidavit shall be signed by the medical director, the consultant
pharmacist, and the owner or chief executive officer of the clinic. In
addition, a petition for an alternative drug transfer system must include a
detailed, written description of the proposed alternative transfer system in
the policy and procedures manual describing:
(i) drug ownership;
(ii) drug ordering;
(iii) drug shipping;
(iv) drug receiving;
(v) drug accountability system;
(vi) formulary for transfer; and
(vii) records of transfer.
(b) The board may approve or deny
the petition for an alternative plan, at the board's discretion. The board may
consider the following:
(i) degree of
compliance by the clinic on past compliance inspections;
(ii) size and type of the patient
population;
(iii) number and types
of drugs contained in the clinic's formulary;
(iv) the clinic's objectives; and
(v) impact on the health and welfare of the
clinic's patients.
(2) A copy of the board approved alternative
plan shall be maintained at the clinic's license location for review by the
board or its agent.
(3) The board
may terminate the alternative plan if the board determines that the clinic's
status or other circumstances justifying the alternative plan have
changed.
S. Class D (SBEM) clinic:
(1) Only trained personnel may
administer epinephrine. Trained personnel can be a school employee, agent or
volunteer who has completed epinephrine administration training documented by
the school nurse, school principal or school leader and approved by the New
Mexico department of health and who has been designated by the school principal
or school leader to administer epinephrine on a voluntary basis outside of the
scope of employment. Epinephrine is administered on the standing order of a
health care practitioner employed or authorized by the New Mexico department of
health. If administering epinephrine, written policies and procedures must be
maintained on the premises. These policies and procedures must follow New
Mexico department of health requirements as well as any policy or procedure
requirement listed in
16.19.10.11 NMAC. Documentation of
New Mexico department of health required training must be maintained on-site
for each trained and authorized person.
(2) Only a school nurse may administer
albuterol to a student who is perceived to be in respiratory distress. Written
policies and procedures must be maintained at the licensed location.
Documentation of New Mexico department of health required training must be
maintained on-site for each nurse.
(3) The following records must be kept
on-site and available for inspection for three years:
(a) receipt records;
(b) destruction or other disposition
records;
(c) storage records;
storage records include daily (on school days) documented drug storage area
temperature; documented verification that medication is sealed in its original
packaging until the time of administration, and secured but unlocked in a
secondary tamper-evident container; dangerous drugs are stored in a restricted
area, unlocked, and readily accessible to trained personnel; policies and
procedures must be in place to ensure proper drug storage conditions on
non-school days;
(d) usage records;
if a dangerous drug is used, a record must be kept; the consultant pharmacist
must be notified within a 72-hour period in order to review the record; in
addition, all New Mexico department of health guidelines must be
followed;
(e) annual
self-assessment form; this form will be supplied by the New Mexico board of
pharmacy and shall be reviewed by the consultant pharmacist at least
annually;
(f) consultant pharmacist
record of activities and comments;
(g) a current copy of facility's New Mexico
board of pharmacy registration and the consultant pharmacist's current license
will be posted in the drug storage area;
(h) policy and procedure manual.
(4) Albuterol and epinephrine must
be stored in a secure but unlocked, temper evident, container. This container
must be in a restricted area but readily accessible to trained personnel. A
list of the contents, including expiration dates, must be posted on the outside
of the container.
T. NTP clinic:
(1) Administering, Dispensing,
Distributing or Supplying:
(a) Drugs shall be
administered, dispensed, distributed, or supplied only to clinic patients on
the order of a licensed practitioner of the clinic. This provision does not
prohibit guest dosing pursuant to policies and procedures and in compliance
with federal law, or supplying an opioid antagonist for rescue use.
(b) The clinic practitioner shall record the
prescribed drug therapy on the patient medical record indicating the name,
strength, quantity and directions for use of the prescribed drug.
(c) The order may then be prepared by the
practitioner, pharmacist, or technician under the supervision of the pharmacist
and a dispensing label affixed to the dispensing unit of each drug. The
pharmacist or practitioner must then provide a final check of the dispensing
unit and sign or initial the prescription or dispensing record.
(d) Methadone for take-home purposes may be
supplied to a clinic patient in a properly labeled dispensing unit by a
registered nurse or licensed practical nurse employed by the NTP. Supplying of
methadone in this manner (pouring and labeling the take home dose) is not
considered dispensing.
(e) The
following information shall appear on the label affixed to the take home
medication unit:
(i) Name of
patient;
(ii) Name of
prescriber;
(iii) Date of
dispensing;
(iv) Directions for
use;
(v) Name, strength, and
quantity of the drug;
(vi)
Expiration date;
(vii) Name,
address and phone number of the clinic;
(viii) Prescription number, if applicable;
and
(ix) Additional required
information, such as federal statement(s)
(2) Records and Reports:
(a) Each NTP clinic, including a mobile NTP,
shall maintain records with the following information for each dangerous drug
administered, dispensed, distributed or supplied indicating:
(i) Name of substance;
(ii) Strength of substance;
(iii) Dosage form;
(iv) Date dispensed;
(v) Adequate identification of the
patient;
(vi) The name of the
prescriber
(vii) Amount
consumed;
(viii) Amount, units, and
dosage form taken home by patient; and
(ix) Initials of personnel who administered,
dispensed, distributed or supplied.
(b) These records will be maintained in an
administration or dispensing, distributing or supplying log at the NTP site, or
in the case of a mobile NTP, at the registered site of the NTP.
(c) As an alternative to maintaining a paper
administration or dispensing, distributing of supplying log, an NTP or its
mobile component may also use an automated/computerized data processing system
for the storage and retrieval of the program's dispensing records, if the
following conditions are met:
(i) The
automated system maintains the information required in paragraph (a)
above;
(ii) The automated system
has the capability of producing a hard copy printout of the program's
administration or dispensing, distributing or supplying records;
(iii) The NTP or its mobile component prints
a hard copy of each day's administration or dispensing, distributing or
supplying log, which is then initialed appropriately by each person who
administered, dispensed, distributed or supplied medication to the program's
patients;
(iv) The automated system
is approved by DEA;
(v) The NTP or
its mobile component maintains an off-site back-up of all computer generated
program information; and
(vi) The
automated system is capable of producing accurate summary reports for both the
registered site of the NTP and any mobile component, for any time-frame
selected by Board personnel during an investigation. If these summary reports
are maintained in hard copy form, they must be kept in a systematically
organized file located at the registered site of the NTP.
(d) The NTP must retain all records for the
NTP as well as any mobile component for three years from the date of
execution.
(3) Patient
Counseling: Each NTP clinic shall develop and provide to the board policies and
procedures addressing patient counseling which are at least equivalent to the
requirements of Subsection F of
16.19.4.16 NMAC. When a medication
is started, the patient should be provided with patient information to
supplement patient counseling. Examples of patient information include, but not
are limited to, written information leaflets, pictogram labels and video
programs. The clinic shall maintain a mechanism for the patient to be provided
with medication information and counseling as requested.
(4) Policies and Procedures: In addition to
requirements of 16.19.10.11(N) NMAC (Procedures Manual), NTPs must maintain
procedures to:
(a) ensure appropriate training
and qualifications of personnel for competent performance of assigned
functions.
(b) ensure appropriate
medication administration and supplying,
(c) ensure appropriate supervision consistent
with state and federal law.
(d)
support prevention of medication errors, including through adequate staffing,
training, and supervision.
(5) Controls: Each NTP clinic must maintain
effective controls and procedures to ensure maintance of required records in
proper form and to identify theft or diversion of NTP clinic controlled
substances.
(6) Responsibility:
While the consultant pharmacist is responsible for overall clinic pharmacy
services, a corresponding responsibility rests with the NTP clinic, the
practitioner, and nurses for ensuring proper completion of medication related
functions and record maintenance as applicable.
(7) Prescription Monitoring Program (PMP)
Utilization: The consultant pharmacist shall request and review a PMP report
covering at least a one year time period and another states' report for each
program patient receiving an opioid, at least quarterly. The pharmacist will
use professional judgement to determine whether more frequent monitoring is
appropriate, as in the case of patients who are receiving a benzodiazepine or
carisoprodol, or an opioid prescribed outside of the NTP. The pharmacist will
use professional judgment in taking steps to avoid or resolve potential isues
identified on PMP report review. The pharmacist shall document review of these
PMP reports, and his or her action regarding such reports.
(8) Moblie NTP: An NTP may operate one or
more mobile NTPs, subject to:
(a) For any NTP
intending to operate a mobile NTP, the NTP must notify the Board, in writing,
of its intent to do so, and the NTP must receive written approval from the
board prior to operating the mobile NTP. The mobile NTP may only operate in New
Mexico.
(b) An NTP clinic is not
required to obtain a separate clinic license or registration for conveyances
(mobile components) utilized by the NTP to transport controlled substances away
from registered locations for administration or provision of take home doses at
unregistered locations as part of a mobile NTP. Vehicles must possess valid
county/city and State information (e.g., a vehicle information number (license
plate number) on file at the registered location of the NTP.
(i) A mobile NTP is not permitted to reverse
distribute, share, or transfer controlled substances from one mobile component
to another mobile component while deployed away from the registered location.
NTPs with mobile components are not allowed to modify their registrations to
authorize their mobile components to act as collectors under
21 CFR
1301.51 and
1317.40. Mobile components of NTPs
may not function as hospitals, long-term care facilities, or emergency medical
service vehicles, and will not transport patients.
(ii) A mobile NTP may operate at any remote
location or locations within the state, including correctional facilities, so
long as doing so is otherwise consistent with applicable Federal, State,
tribal, and local laws and regulations, and so long as the local DEA office,
does not otherwise direct.
(c) Physical security controls, mobile NTP;
storage areas:
(i) For any conveyance operated
as a mobile narcotic treatment program (NTP), a safe must be installed and used
to store narcotic drugs in schedules II-V for the purpose of maintenance or
detoxification treatment, when not located at the clinic's registered location.
The safe must conform to the requirements set forth in
21 CFR
1301.72(a)(1).
(ii) The mobile component must also be
equipped with an alarm system that conforms to the requirements set forth
21 CFR
1301.70
(a)(1)(iii).
(iii) Accessibility to storage areas. The
controlled substances storage areas shall be accessible only to an absolute
minimum number of specifically authorized employees. When it is necessary for
employee maintenance personnel, nonemployee maintenance personnel, business
guests, or visitors to be present in or pass through controlled substances
storage areas, the NTP shall provide for adequate observation of the area by an
employee specifically authorized in writing. The storage area for controlled
substances in a mobile component of an NTP must not be accessible from outside
of the vehicle. Personnel transporting the controlled substances on behalf of
the mobile NTP are required to retain control over all controlled substances
when transferring them between the registered location and the conveyance, and
when providing medication to patients at remote locations. At all other times
during transportation, all controlled substances must be properly secured in
the safe. Upon completion of the operation of the mobile NTP on a given day,
the conveyance must be immediately returned to the registered location, and all
controlled substances must be removed from the conveyance and secured within
the registered location. After the conveyance has returned to the registered
location and the controlled substances have been removed, the conveyance may be
parked until its next use at the registered location or any secure, fenced-in
area, once the local DEA office has been notified of the location of this
secure, fenced-in area. All NTPs with mobile components shall be required to
establish a standard operating procedure to ensure, if the mobile component
becomes inoperable (mechanical failure, accidents, fire, etc.), that all
controlled substances on the inoperable conveyance are accounted for, removed
from the inoperable conveyance, and secured at the registered
location.
(iv) Upon completion of
the operation of the mobile NTP on a given day, the conveyance must be
immediately returned to the registered location, and all controlled substances
must be removed from the conveyance and secured within the registered location.
An NTP may apply for an exception to this requirement after receiving an
exception from the DEA.
(d) Other security controls: Persons enrolled
in any NTP, including those receiving treatment at a mobile NTP, will be
required to wait in an area that is physically separated from the narcotic
storage and preparation area by a physical entrance such as a door or other
entryway. Patients must wait outside of a mobile NTP component if that
conveyance does not have seating or a reception area that is separated from the
narcotic storage and preparation area. This requirement will be enforced by the
program practitioner and NTP employees.
(e) Any controlled substances being
transported for disposal from the remote location of a mobile NTP shall be
secured and disposed of in compliance with 21 CFR part 1317 , and all other
applicable Federal, State, tribal, and local laws and regulations.
(f) A conveyance used as part of a mobile NTP
may only be supplied with narcotic drugs by the registered NTP that operates
such conveyance.
Disclaimer: These regulations may not be the most recent version. New Mexico may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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