reglab/statecodes huggingface dataset:
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 29 - CONTROLLED SUBSTANCE PRESCRIPTION MONITORING PROGRAM › Section 16.19.29.12 - REGISTRATION FOR ACCESS TO PRESCRIPTION INFORMATION

Current through Register Vol. 35, No. 13, July 16, 2024
A. Persons authorized for access to PMP
				information as listed in Paragraphs (1) through (10) and (14) of Subsection D
				of
				16.19.29.9
				NMAC must apply for access as described at the PMP website located at
http://nmpmp.org
or as otherwise
				indicated. Persons granted access must maintain individual accounts and shall
				not share access information with other persons.
B. All persons authorized for access to PMP
				information and applying for such access to the PMP shall successfully complete
				a web based training program as determined by the PMP director.
C. Persons reporting prescription information
				to the PMP, but not authorized for access to PMP information must also apply
				for access as described at the PMP website located at
http://nmpmp.org
or as otherwise
				indicated.
D. The PMP director
				shall have the authority to set account access and registration renewal
				requirements necessary for accounts to be considered active and shall also have
				authority to cancel inactive accounts.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 29 - CONTROLLED SUBSTANCE PRESCRIPTION MONITORING PROGRAM › Section 16.19.29.13 - INFORMATION EXCHANGE WITH OTHER PRESCRIPTION MONITORING PROGRAMS

Current through Register Vol. 35, No. 13, July 16, 2024
A. The board may
				provide PMP information to other states' prescription monitoring programs and
				such information may be used by those programs consistent with the provisions
				of this rule.
B. The board may
				request and receive PMP information from other states' prescription monitoring
				programs and may use such information under provisions of this rule.
C. The board may develop the capability to
				transmit information to and receive information from other prescription
				monitoring programs employing the standards of interoperability.
D. The board may enter into written
				agreements with other states' prescription monitoring programs or other persons
				hosting compatible information sharing technologies for the purpose of
				describing the terms and conditions for sharing of PMP information under this
				section.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 29 - CONTROLLED SUBSTANCE PRESCRIPTION MONITORING PROGRAM › Section 16.19.29.14 - PENALTIES

Current through Register Vol. 35, No. 13, July 16, 2024
A. A dispenser who
				knowingly fails to submit prescription monitoring information to the board as
				required by this rule or knowingly submits incorrect prescription information
				shall be subject to disciplinary proceedings as defined in Section
				61-11-20
				of the Pharmacy Act, NMSA 1978.
B.
				Prescription information submitted to the PMP is protected health information.
				Persons with access to the PMP shall exercise due diligence in protecting this
				information and access it only as necessary in the course of legitimate
				professional regulatory, or law enforcement duties.
C. A person found to be in violation of this
				section may be subject to one or more of the following actions.
(1) Termination of access to PMP
				information.
(2) A complaint may be
				filed with his or her appropriate professional licensing entities.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 29 - CONTROLLED SUBSTANCE PRESCRIPTION MONITORING PROGRAM › Section 16.19.29.15 - SEVERABILITY

Current through Register Vol. 35, No. 13, July 16, 2024
If any provisions of this rule or its application to any
				  person or circumstance is held invalid or unenforceable, the remainder of this
				  rule shall not be affected and shall be valid and
				  enforceable.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 30 - COMPOUNDING OF NON-STERILE PHARMACEUTICALS › Section 16.19.30.2 - SCOPE

Current through Register Vol. 35, No. 13, July 16, 2024
All pharmacies as defined in Subsections S and Z of Section
				  61-11-2
				  NMSA 1978, and all persons or entities that own or operated, or are employed by
				  a pharmacy for the purpose of providing pharmaceutical products or
				  services.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 30 - COMPOUNDING OF NON-STERILE PHARMACEUTICALS › Section 16.19.30.3 - STATUTORY AUTHORITY

Current through Register Vol. 35, No. 13, July 16, 2024
Paragraph (6) of Subsection A of Section
				  61-11-6
				  NMSA 1978 requires that the board of pharmacy provide for the licensing of
				  retail pharmacies and nonresident pharmacies and for the inspection of their
				  facilities and activities.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 30 - COMPOUNDING OF NON-STERILE PHARMACEUTICALS › Section 16.19.30.5 - EFFECTIVE DATE

Current through Register Vol. 35, No. 13, July 16, 2024
09-15-06, unless a later date is cited at the end of a
				  section.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 30 - COMPOUNDING OF NON-STERILE PHARMACEUTICALS › Section 16.19.30.6 - OBJECTIVE

Current through Register Vol. 35, No. 13, July 16, 2024
The objective of part 30 of chapter 19 is to provide
				  standards for the compounding of non-sterile pharmaceuticals. Pharmacies
				  compounding non-sterile pharmaceuticals shall comply with the requirements of
				  this section in addition to all provisions for their specific license
				  classification.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 30 - COMPOUNDING OF NON-STERILE PHARMACEUTICALS › Section 16.19.30.7 - DEFINITIONS

Current through Register Vol. 35, No. 13, July 16, 2024
In addition to the definitions for specific license
				  classifications, the following words and terms, when used in this section,
				  shall have the following meanings unless the context clearly indicates
				  otherwise.
A.
"Active
				pharmaceutical ingredient (API)"
any substance or mixture of substances
				intended to be used in the compounding of a drug preparation, thereby becoming
				the active ingredient in that preparation and furnishing pharmacological
				activity or other direct effect in the diagnosis, cure, mitigation, treatment,
				or prevention of disease in humans and animals or affecting the structure and
				function of the body.
B.
"Beyond-use date (BUD)"
the date after which a compounded
				preparation should not be used and is determined from the date the preparation
				was compounded.
C.
"Component"
any ingredient intended for use in the compounding of
				a drug product, including those that may not appear in such product
				labeling.
D.
"Compounding"
the preparation, mixing, assembling, packaging, or
				labeling of a drug or device (reconstitution of commercial products is not
				considered compounding for purposes of this article).
(1) as the result of a practitioner's
				prescription order, based on the practitioner-patient-pharmacist relationship
				in the course of professional practice;
(2) preparing limited quantities of
				prescription orders based upon a history of receiving valid prescriptions
				issued within an established practitioner-patient-pharmacist relationship in
				the course of professional practice;
(3) reconstitution of commercial products is
				not considered compounding for purpose of this article.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 30 - COMPOUNDING OF NON-STERILE PHARMACEUTICALS › Section 16.19.30.8 - PERSONNEL

Current through Register Vol. 35, No. 13, July 16, 2024
A.
				Pharmacist-in-charge. The pharmacist-in-charge shall have the responsibility
				for, at a minimum, the following concerning non-sterile compounding:
(1) determining that all personnel involved
				in non-sterile compounding possess the education, training, and proficiency
				necessary to properly and safely perform compounding duties undertaken or
				supervised;
(2) determining that
				all personnel involved in non-sterile compounding obtain continuing education
				appropriate for the type of compounding done by the personnel;
(3) assuring that the equipment used in
				compounding is properly maintained;
(4) maintaining an appropriate environment in
				the area where non-sterile compounding occurs;
(5) assuring that effective quality control
				procedures are developed and followed; and
(6) assuring availability of current
				reference source for the type of compounding conducted.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 30 - COMPOUNDING OF NON-STERILE PHARMACEUTICALS › Section 16.19.30.10 - RECORDS

Current through Register Vol. 35, No. 13, July 16, 2024
A. Maintenance of
				records. Every record required by this section shall be kept by the pharmacy
				for at least three (3) years.
B.
				Compounding records.
(1) Formulation records:
(a) provides a consistent source document for
				preparing the preparation (recipe);
(b) is a file of individual compounded
				preparations;
(c) must list the
				name, strength, and dosage form of the preparation compounded;
(d) must list all ingredients and their
				quantities;
(e) must list equipment
				needed to prepare the preparation, when appropriate, and mixing
				instructions;
(f) other
				environmental controls, such as the duration of mixing and other factors
				pertinent to the replication of the preparation as compounded; and
(g) must contain beyond-use date and
				methodology, the container used in dispensing, the storage requirements, and
				any quality control procedures.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 31 - EMERGENCY PROVISIONS › Section 16.19.31.2 - SCOPE

Current through Register Vol. 35, No. 13, July 16, 2024
All pharmacies, resident and non-resident, as defined in
				  Subsections S and Z of Section
				  61-11-2
				  NMSA 1978, and all persons or entities that own or operate, or are employed by,
				  a pharmacy for the purpose of providing pharmaceutical products or services.
				  Pharmacists and technicians subject to licensure, registration, and regulation
				  by the Board of Pharmacy. Practitioners subject to registration by the Board of
				  Pharmacy pursuant to Section
				  30-31-12
				  of the Controlled Substances Act.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 31 - EMERGENCY PROVISIONS › Section 16.19.31.3 - STATUTORY AUTHORITY

Current through Register Vol. 35, No. 13, July 16, 2024
Paragraph (1) of Subsection A of Section
				  61-11-6
				  NMAC 1978 authorizes the Board of Pharmacy to adopt, regularly review and
				  revise rules and regulations necessary to carry out the provisions of the
				  Pharmacy Act, Sections
				  61-11-1,
				  61-11-2,
				  61-11-4
				  to
				  61-11-28
				  NMSA 1978. Paragraph (3) of Subsection A of Section
				  61-11-6
				  NMSA 1978 provides for the issuance and renewal of licenses for pharmacists.
				  Paragraph (4) of Subsection A of Section
				  61-11-6
				  authorizes the Board of Pharmacy to require and establish criteria for
				  continuing education as a condition of renewal of licensure for pharmacists.
				  Paragraph (16) of Subsection A of Section
				  61-11-6
				  NMSA 1978 authorizes the Board of Pharmacy to register and regulate
				  qualifications, training and permissible activities of pharmacy technicians.
				  Paragraph (6) of Subsection A of Section
				  61-11-6
				  NMSA 1978 requires that the Board of Pharmacy provide for the licensing of
				  retail pharmacies and nonresident pharmacies and for the inspection of their
				  facilities and activities. Section
				  30-31-11
				  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. Section
				  30-31-12
				  NMSA 1978 requires Board registration to engage in activities relating to
				  controlled substances including possession, dispensing, prescribing or
				  conducting research.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 31 - EMERGENCY PROVISIONS › Section 16.19.31.5 - EFFECTIVE DATE

Current through Register Vol. 35, No. 13, July 16, 2024
April 3, 2006, unless a later date is cited in the history
				  note at the end of a Section.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 31 - EMERGENCY PROVISIONS › Section 16.19.31.6 - OBJECTIVE

Current through Register Vol. 35, No. 13, July 16, 2024
The objective of Part 31 of Chapter 19 is to ensure the safe
				  and competent delivery of quality pharmaceutical products and services to the
				  public by establishing standards for the operation of pharmacies, including but
				  not limited to minimum space requirements and standards for equipment,
				  accessories, personnel, dispensing, labeling and advertising during emergency
				  situations.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 31 - EMERGENCY PROVISIONS › Section 16.19.31.7 - DEFINITIONS

Current through Register Vol. 35, No. 13, July 16, 2024
The following words and terms, when used in this subchapter,
				  shall have the following meanings, unless the context clearly indicates
				  otherwise.
A. Emergency situation -
				and emergency caused by a natural or manmade disaster or any other exceptional
				situation that causes and extraordinary demand for pharmacist
				services.
B. Sponsoring pharmacy -
				a pharmacy licensed by the board in which the emergency temporary pharmacist
				will practice.
C. State - One of
				the 50 United States of America, the District of Columbia, and Puerto
				Rico.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 31 - EMERGENCY PROVISIONS › Section 16.19.31.8 - EMERGENCY TEMPORARY PHARMACIST LICENSE

Current through Register Vol. 35, No. 13, July 16, 2024
A. Emergency temporary pharmacist license. In
				an emergency situation, the board may grant a pharmacist who holds a license to
				practice pharmacy in another state an emergency temporary pharmacist license to
				practice in New Mexico. The following is applicable for the emergency temporary
				pharmacist license.
(1) An applicant for an
				emergency temporary pharmacist license under this section must:
(a) hold a current pharmacist license in
				another state and that license and other licenses held by the applicant in any
				other state may not be suspended, revoked, canceled, surrendered, or otherwise
				restricted for any reason; and
(b)
				be sponsored by a pharmacy with an active license in New Mexico.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 31 - EMERGENCY PROVISIONS › Section 16.19.31.9 - PROVISIONS FOR PHARMACIST LICENSURE DURING DECLARED DISASTER

Current through Register Vol. 35, No. 13, July 16, 2024
A. Emergency
				provisions for license by endorsement. Pharmacist currently licensed in a state
				in which a federal disaster has been declared may be licensed by endorsement in
				New Mexico during the four months following the declared disaster at no cost
				with the following requirements:
(1) receipt
				of a completed application which has been signed and notarized accompanied by
				proof of identity, which may include a copy of a drivers license, passport or
				other photo identification issued by a governmental entity;
(2) other required verification will be
				obtained online if possible by board staff to include:
(a) current licensure status;
(b) national pharmacists data bank;
(c) national association of boards of
				pharmacy disciplinary database; and
(3) nothing in this provision shall
				constitute a waiver of the requirements for licensure contained in 16.19.2
				NMAC.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 31 - EMERGENCY PROVISIONS › Section 16.19.31.10 - PROVISIONS FOR PRACTITIONER CONTROLLED SUBSTANCES REGISTRATION DURING A DECLARED DISASTER

Current through Register Vol. 35, No. 13, July 16, 2024
A.
				Emergency provisions for registration by endorsement. Practitioners currently
				possessing a temporary license issued by a New Mexico regulatory agency and
				possessing a current drug enforcement administration controlled substance
				registration in a state in which a federal disaster has been declared may be
				registered by endorsement in New Mexico during the four months following the
				declared disaster at no cost with the following requirements:
(1) receipt of a completed application which
				has been signed and accompanied by proof of identity, which may include a copy
				of a drivers license, passport or other photo identification issued by a
				governmental entity;
(2) other
				required verification will be obtained online if possible by board staff to
				include: current licensure status, national practitioners data banks;
				and
(3) nothing in this provision
				shall constitute a waiver of the requirements for licensure contained in
				16.19.20 NMAC.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 31 - EMERGENCY PROVISIONS › Section 16.19.31.11 - PROVISIONS FOR PHARMACIST OR PHARMACY TECHNICIAN, UNAVAILABLE TESTING OR TRAINING

Current through Register Vol. 35, No. 13, July 16, 2024
A. During
				a declared civil or public health emergency resulting in unavailable required
				testing or training, the board may authorize a temporary extension for a:
(1) temporary pharmacist license under
				reciprocity issued pursuant to 16.19.3 NMAC;
(2) pharmacy technician
				registration;
(3) pharmacist to
				exercise prescriptive authority pursuant to 16.19.26 NMAC (e.g. current live
				basic life support/cardiopulmonary resuscitation).
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 32 - WAIVER PROVISIONS › Section 16.19.32.2 - SCOPE

Current through Register Vol. 35, No. 13, July 16, 2024
Any person or business pursuant to
				  26-1-17 of the
				  New Mexico Drug, Device and Cosmetic Act, 30-31-12(A), (B) of the Controlled
				  Substance Act, and
				  61-11-9,
				  61-11-11,
				  61-11-11.1,
				  61-11-14(A), (B) of the Pharmacy Act.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 32 - WAIVER PROVISIONS › Section 16.19.32.3 - STATUTORY AUTHORITY

Current through Register Vol. 35, No. 13, July 16, 2024
Section 26-1-18(A) NMSA 1978 authorizes the board to
				  promulgate regulations for the efficient enforcement of the New Mexico Drug,
				  Device and Cosmetic Act (26-1-1 NMSA 1978).
				  The board shall conform the regulations promulgated under the New Mexico Drug,
				  Device and Cosmetic Act, insofar as practical, with regulations promulgated
				  under the federal act as defined in Section
				  26-1-2
				  NMSA 1978. Section
				  30-31-11
				  NMSA 1978 authorizes the board to promulgate regulations and charge reasonable
				  fees relating to the registration and control of the manufacture, distribution
				  and dispensing of controlled substances. Section 61-11-6(A)(1) NMSA 1978
				  authorizes the board of pharmacy to adopt, regularly review and revise rules
				  and regulations necessary to carry out the provisions of the Pharmacy Act.
				  Section
				  61-11B-3
				  NMSA 1978 authorizes the board to adopt regulations to carry out the provisions
				  of the Pharmacist Prescriptive Authority Act. Section
				  30-31B-6
				  NMSA 1978 authorizes the board to promulgate regulations and charge reasonable
				  fees relating to the licensing and control of the manufacture, possession,
				  transfer and transportation of drug precursors.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 32 - WAIVER PROVISIONS › Section 16.19.32.5 - EFFECTIVE DATE

Current through Register Vol. 35, No. 13, July 16, 2024
April 30, 2007, unless a later date is cited in the history
				  note at the end of a section.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 32 - WAIVER PROVISIONS › Section 16.19.32.6 - OBJECTIVE

Current through Register Vol. 35, No. 13, July 16, 2024
This regulation established guidelines to waive provisions of
				  the New Mexico board of pharmacy regulations as authorized by
				  law.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 32 - WAIVER PROVISIONS › Section 16.19.32.7 - DEFINITIONS

Current through Register Vol. 35, No. 13, July 16, 2024
"Waive/waivers" means to refrain from pressing or enforcing
				  compliance with certain regulations for the specified period of time provided
				  the health, safety, or welfare of patients and staff are not in danger. Waivers
				  are issued at the sole discretion of the New Mexico board of
				  pharmacy.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 32 - WAIVER PROVISIONS › Section 16.19.32.8 - PROVISIONS FOR ENTITY SEEKING TO OBTAIN A WAIVER

Current through Register Vol. 35, No. 13, July 16, 2024
A. Petition for a waiver must be submitted to
				the board of pharmacy. Waivers granted by the board are limited to use by the
				party and business specified in the waiver document and other limitations set
				forth. Such petitions shall include:
(1) name
				of party;
(2) address of the
				business;
(3) type of
				business;
(4) reason for waiver
				request, including each affected New Mexico administrative code
				citation;
(5) supporting
				documents;
(6) the expected public
				benefit as a result of the waiver, and;
(7) other information requested by the board
				as deemed necessary.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 33 - TELE-PHARMACY AND REMOTE DISPENSING › Section 16.19.33.2 - SCOPE

Current through Register Vol. 35, No. 13, July 16, 2024
This section applies to hub pharmacies and remote
				  tele-pharmacies. Both the hub pharmacy and remote tele-pharmacy must be located
				  within and licensed by the New Mexico board of pharmacy. The remote
				  tele-pharmacy must be greater than 20 miles from an existing retail pharmacy to
				  qualify under these rules.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 33 - TELE-PHARMACY AND REMOTE DISPENSING › Section 16.19.33.3 - STATUTORY AUTHORITY

Current through Register Vol. 35, No. 13, July 16, 2024
Section
				  61-11-6.A.(6)
				  NMSA 1978 requires that the board of pharmacy provide for the licensing of
				  retail pharmacies and nonresident pharmacies and for the inspection of their
				  facilities and activities. Section
				  61-11-6.A.(1)
				  NMSA 1978 requires the board of pharmacy to adopt, regularly review and revise
				  or repeal rules and regulations necessary to carry out the provisions of the
				  Pharmacy Act.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 33 - TELE-PHARMACY AND REMOTE DISPENSING › Section 16.19.33.5 - EFFECTIVE DATE

Current through Register Vol. 35, No. 13, July 16, 2024
May 14, 2010, unless a different date is cited at the end of
				  a section.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 33 - TELE-PHARMACY AND REMOTE DISPENSING › Section 16.19.33.6 - OBJECTIVE

Current through Register Vol. 35, No. 13, July 16, 2024
The objective of Part 33 of Chapter 19 is to ensure the safe
				  and competent delivery of quality pharmaceutical products and the provision of
				  pharmaceutical care to the public by establishing standards for the operation
				  of remote dispensing sites and tele-pharmacy, including but not limited to
				  minimum space requirements and standards for equipment, accessories, personnel,
				  dispensing and labeling.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 33 - TELE-PHARMACY AND REMOTE DISPENSING › Section 16.19.33.8 - PURPOSE

Current through Register Vol. 35, No. 13, July 16, 2024
The board is responsiblefor maintaining, continuing and
				  enhancing the development of the education and professional role of the
				  pharmacist for the protection of the health, welfare and safety of the citizens
				  of New Mexico. In order to maintain, augment or expand the availability of
				  pharmacy services in communities that have pharmacy access issues, rules are
				  necessary to permit remote tele-pharmacy services and remote
				  dispensing.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 34 - PRESCRIPTION DRUG DONATIONS › Section 16.19.34.2 - SCOPE

Current through Register Vol. 35, No. 13, July 16, 2024
This section applies to licensed clinics and participating
				  practitioners located within the state of New Mexico who provide for the
				  donation and redistribution of previously dispensed prescription drugs that
				  have not been used.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 34 - PRESCRIPTION DRUG DONATIONS › Section 16.19.34.3 - STATUTORY AUTHORITY

Current through Register Vol. 35, No. 13, July 16, 2024
Section
				  26-1-3.2
				  of the New Mexico Drug, Device and Cosmetic Act requires the board of pharmacy
				  to promulgate rules establishing standards and procedures necessary for the
				  safe redistribution of previously dispensed prescription drugs.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 34 - PRESCRIPTION DRUG DONATIONS › Section 16.19.34.6 - OBJECTIVE

Current through Register Vol. 35, No. 13, July 16, 2024
The objective of Part 34 of Chapter 19 is to ensure the safe
				  donation and redistribution of unused prescription drugs by licensed clinics
				  and participating practitioners by establishing standards and procedures
				  including but not limited to accepting, storing, packaging, labeling,
				  inspecting, record keeping and disposal.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 34 - PRESCRIPTION DRUG DONATIONS › Section 16.19.34.7 - DEFINITIONS

Current through Register Vol. 35, No. 13, July 16, 2024
A. "Board" means
				the New Mexico board of pharmacy.
B. "Clinic" means a facility licensed
				pursuant to Section 61-22-14 NMSA 1978 in which one or more licensed
				practitioners diagnose and treat patients and in which drugs are stored,
				dispensed or administered for the diagnosis and treatment of the facility's
				patients; provided that "clinic" does not include the privately owned practice
				of a licensed practitioner or group of licensed practitioners exempt under
				Section
				61-11-11
				NMSA 1978.
C. "Donor" means an
				individual who donates an unused prescription drug to a clinic or participating
				practitioner, who originally prescribed that prescription drug for their
				patient, for the purpose of redistribution of established patients of that
				clinic or practitioner.
D.
				"Eligible drug" means an unused prescription drug stored in a tamper-evident
				container, or by a tamper-evident process preventing unauthorized access, and
				has an expiration date of six months or greater listed on the packaging. No
				drug shall be re-dispensed more than one time.
E. "Ineligible drug" means any controlled
				substances or any prescription drug within the risk evaluation and mitigation
				strategies (REMS) requirements as set forth by Section 505-1[
				21
				USC355-1 ] of the Food Drug and Cosmetic Act
				(FD&C Act), with the exception of a medication guide (MedGuide) as set
				forth in Title 34, CFR, Subsection 208, patient package insert (PPI) or a
				communication plan, without prior board approval.
F. "Participating practitioner" means a
				licensed practitioner who is authorized to prescribe drugs, who registers with
				the board and is subject to rules promulgated by the board to participate in
				the collection of donated drugs prescribed for use by established patients of
				that practitioner, and donated for the purpose of redistribution to established
				patients of that practitioner.
G.
				"Prescription drug" for the purposes of this rule means any drug required by
				federal or state law or regulation to be dispensed only by a prescription,
				including finished dosage forms and active ingredients subject to Section
				503(b) of the Federal Food, Drug and Cosmetic Act.
H. "Recipient" means an individual who
				voluntarily receives donated prescription drugs.
I. "Tamper-evident" means a device or process
				that makes unauthorized access to protected pharmaceutical packaging easily
				detected.
J. "REMS" means risk
				evaluation and mitigation strategy as required by the Food and Drug
				Administration Amendments Act of 2007.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 34 - PRESCRIPTION DRUG DONATIONS › Section 16.19.34.8 - PROCEDURES

Current through Register Vol. 35, No. 13, July 16, 2024
All clinics and participating practitioners shall follow the
				  procedures for accepting and redistributing certain donated prescription drugs,
				  including refrigerated drugs, consistent with public health and safety
				  standards.
A. Before accepting donated
				prescription drugs the clinic or the participating practitioner shall:
(1) register with the New Mexico board of
				pharmacy as a practitioner who will facilitate prescription drug
				donation;
(2) provide donor with
				appropriate form for documentation and verification upon acceptance of an
				eligible donated drug;
(3) identify
				drug as eligible or ineligible prior to accepting the donated drug;
(a) ineligible drugs may not be accepted for
				donation;
(b) only drugs originally
				prescribed by a licensed clinic or practitioner may be accepted.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 34 - PRESCRIPTION DRUG DONATIONS › Section 16.19.34.9 - RECORD KEEPING

Current through Register Vol. 35, No. 13, July 16, 2024
All clinics and participating practitioners shall provide
				  separate records or forms documenting the receipt and redistribution of all
				  unused prescription drugs and maintain the records for three years.
A. A form to be signed by the donor serving
				as receipt of the drug verifying the donor voluntarily donating the drug, the
				donated prescription drug has been properly stored-not stored at temperature
				extremes nor hazardous conditions and protected from light and humidity, the
				container has not been tampered with, and the drug has not been adulterated or
				misbranded. The form shall include at least the following:
(1) date the drug was donated;
(2) name, address and telephone number of
				donor;
(3) name, strength and
				quantity of the drug;
(4)
				manufacturer and lot number (if applicable) of drug;
(5) the expiration date of drug;
(6) name, date and signature of the
				practitioner or pharmacist who is accepting and inspecting the donated
				drugs.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 34 - PRESCRIPTION DRUG DONATIONS › Section 16.19.34.10 - LIABILITY

Current through Register Vol. 35, No. 13, July 16, 2024
A. Any person who
				exercises reasonable care in donating, accepting or redistributing prescription
				drugs pursuant to this section shall be immune from civil or criminal liability
				or professional disciplinary action of any kind for any related injury, death
				or loss.
B. The immunity provided
				by this section shall not decrease or increase the civil or criminal liability
				of a drug manufacturer, distributor or dispenser that would have existed but
				for the donation.
C. A manufacturer
				shall not be liable for failure to transfer or communicate product consumer
				information or the expiration date of the donated prescription drug pursuant to
				this section.
D. This section does
				not restrict the authority of an appropriate government agency to regulate or
				ban the use of any prescription drugs.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 34 - PRESCRIPTION DRUG DONATIONS › Section 16.19.34.11 - PARTICIPATING PRACTITIONERS AND LICENSED CLINICS

Current through Register Vol. 35, No. 13, July 16, 2024
A. Practitioners and licensed clinics must
				submit the required application form provided by the board to obtain
				eligibility for participation.
B.
				The board may remove at any time practitioners or any licensed clinics from
				participating in the reuse of prescription drug donation should they fail to
				comply with regulations stated therein.
C. The board shall maintain and publish a
				current listing of participating practitioners and licensed clinics including
				names(s) and address.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 34 - PRESCRIPTION DRUG DONATIONS › Section 16.19.34.12 - DISPOSAL

Current through Register Vol. 35, No. 13, July 16, 2024
Participating practitioners and licensed clinics may dispose
				  of unused donated prescription drugs, that were collected but not
				  redistributed, in accordance with state and federal requirements for disposal
				  of prescription drugs.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 34 - PRESCRIPTION DRUG DONATIONS › Section 16.19.34.13 - RECALLS

Current through Register Vol. 35, No. 13, July 16, 2024
Participating practitioners shall monitor FDA recalls, market
				  withdrawals, and safety alerts and will communicate with recipients if
				  medications they received may be impacted by this FDA action.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 35 - DRUG WAREHOUSE › Section 16.19.35.3 - STATUTORY AUTHORITY

Current through Register Vol. 35, No. 13, July 16, 2024
Section 61-11-6(A)(6) NMSA 1978 authorizes the board of
				  pharmacy to provide for the licensing of all places where dangerous drugs are
				  stored or administered and for the inspection of their facilities and
				  activities. Section 61-11-14(B)(10) NMSA 1978 authorizes the board to issue
				  limited drug permits for home care services.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 35 - DRUG WAREHOUSE › Section 16.19.35.6 - OBJECTIVE

Current through Register Vol. 35, No. 13, July 16, 2024
The objective of Part 35 of Chapter 19 is to establish
				  standards for the safe and competent storage of pharmaceutical products in
				  facilities located off-site from the licensed clinic, hospital or
				  pharmacy.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 35 - DRUG WAREHOUSE › Section 16.19.35.7 - DEFINITIONS

Current through Register Vol. 35, No. 13, July 16, 2024
"Drug warehouse" means an off-site physical storage location
				  of a clinic, hospital or pharmacy currently licensed by the New Mexico board of
				  pharmacy. Dangerous drugs may be stored for the use of the licensed clinic,
				  hospital or pharmacy.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 35 - DRUG WAREHOUSE › Section 16.19.35.8 - FACILITIES

Current through Register Vol. 35, No. 13, July 16, 2024
A. All facilities
				at which prescription drugs are stored shall:
(1) be of suitable size and construction to
				facilitate cleaning, maintenance and proper operations;
(2) have storage areas designed to provide
				adequate lighting, ventilation, temperature, sanitation, humidity, space,
				equipment and security;
(3) have a
				quarantine area for storage of prescriptions that are outdated, damaged,
				deteriorated, misbranded, counterfeit or suspected of being counterfeit or
				adulterated, otherwise unfit for use;
(4) be maintained in a clean and orderly
				condition;
(5) be free from
				infestation by insects, rodents, birds, or vermin of any kind;
(6) be a commercial location and not a
				personal dwelling or residence;
(7)
				provide and maintain appropriate inventory controls in order to detect and
				document any theft, counterfeiting or diversion of prescription drugs or
				devices.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 35 - DRUG WAREHOUSE › Section 16.19.35.9 - STORAGE

Current through Register Vol. 35, No. 13, July 16, 2024
All prescription drugs shall be stored at appropriate
				  temperatures and under appropriate conditions in accordance with requirements,
				  if any, in the labeling of such drugs, or in compliance with standards in the
				  current edition of an official compendium, such as United States
				  pharmacopeia-national formulary (USP/NF).
A. If no requirements are established for a
				prescription drug, the drug may be held at "controlled" room temperature, as
				defined in an official compendium, to help ensure that its identity, strength,
				quality and purity are not adversely affected.
B. Appropriate manual, electromechanical, or
				electronic temperature and humidity recording equipment, devices or logs shall
				be utilized to document proper storage of prescription drugs.
C. The record keeping requirements in
				Subsection F of 16.19.8.13 NMAC shall be followed for all stored prescription
				drugs.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 35 - DRUG WAREHOUSE › Section 16.19.35.10 - SECURITY

Current through Register Vol. 35, No. 13, July 16, 2024
A. All facilities
				used for drug warehouses shall be secure from unauthorized entry and;
(1) access from outside the premises shall be
				kept to a minimum and well-controlled;
(2) the outside perimeter of the premises
				shall be well-lighted;
(3) entry
				into areas where prescription drugs are held shall be limited to authorized
				personnel.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 35 - DRUG WAREHOUSE › Section 16.19.35.11 - EXAMINATION OF MATERIALS

Current through Register Vol. 35, No. 13, July 16, 2024
A.
				Upon receipt, each outside shipping container shall be visually examined for
				identity and to prevent the acceptance of contaminated prescription drugs or
				prescription drugs that are otherwise unfit for distribution. This examination
				shall be adequate to reveal container damage that would suggest possible
				contamination, adulteration, misbranding, counterfeiting, contraband, suspected
				of being counterfeit or contraband, or other damage to the contents.
B. Each outgoing shipment shall be carefully
				inspected for identity of the prescription drug products and to ensure that
				there is no delivery of prescription drugs that have been damaged in storage or
				held under improper conditions.
C.
				Upon receipt, a drug warehouse must review records for the acquisition of
				prescription drugs or devices for accuracy and completeness.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 35 - DRUG WAREHOUSE › Section 16.19.35.12 - RECORD KEEPING

Current through Register Vol. 35, No. 13, July 16, 2024
A. Drug
				warehouses shall establish and maintain inventories and records of all
				transactions regarding receipt and distribution of other disposition of
				prescription drugs. These records shall be maintained at the clinic, hospital
				or pharmacy and must include the following information:
(1) the identity and quantity of the drugs
				received and distributed or disposed of; and
(2) the dates of receipt and distribution or
				other disposition of the drugs;
(3)
				the name, location and license number of the business, health care practitioner
				or other entity appropriately licensed to possess, dispense, distribute,
				administer or destroy prescription drugs.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 35 - DRUG WAREHOUSE › Section 16.19.35.13 - WRITTEN POLICIES AND PROCEDURES

Current through Register Vol. 35, No. 13, July 16, 2024
A. Drug warehouses shall establish, maintain
				and adhere to written policies and procedures which shall be followed:
(1) for the receipt, security, storage,
				inventory, and distribution of prescription drugs, including policies and
				procedures;
(2) for identifying,
				recording and reporting losses or thefts; and
(3) for correcting all errors and
				inaccuracies in inventories.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 35 - DRUG WAREHOUSE › Section 16.19.35.14 - RESPONSIBLE PERSONS

Current through Register Vol. 35, No. 13, July 16, 2024
Drug warehouses shall establish and maintain lists of
				  officers, directors, managers and other persons in charge of drug warehouse
				  storage and handling, including a description of their duties and a summary of
				  their qualifications.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 35 - DRUG WAREHOUSE › Section 16.19.35.15 - COMPLIANCE WITH FEDERAL, STATE AND LOCAL LAW

Current through Register Vol. 35, No. 13, July 16, 2024
Drug warehouses shall operate in compliance with applicable
				  federal, state and local laws and regulations.
A. Drug warehouses shall permit board
				authorized personnel and authorized federal, state and local law enforcement
				officials to enter and inspect their premises, delivery vehicles and to audit
				their records and written operating procedures, at reasonable times and in a
				reasonable manner, to the extent authorized by law. Such officials shall be
				required to show appropriate identification prior to being permitted access to
				wholesale drug distributors' premises and delivery vehicles.
B. Drug warehouses that deal in controlled
				substances shall register with the board and the DEA and shall comply with all
				applicable state, local and DEA regulations.
C. A licensed drug warehouse may distribute
				only to persons who are licensed to possess dangerous drugs.
D. Controlled substances may only be
				distributed or delivered to persons in this state who are registered by the
				board and the DEA to possess controlled substances.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 35 - DRUG WAREHOUSE › Section 16.19.35.17 - MINIMUM QUALIFICATIONS

Current through Register Vol. 35, No. 13, July 16, 2024
A. The
				board shall consider, at a minimum, the following factors in reviewing the
				qualifications of persons who engage in warehousing of prescription drugs
				within the state:
(1) any conviction of the
				applicant under any federal, state or local laws relating to drug samples,
				wholesale or retail drug distribution, or distribution of controlled
				substances;
(2) any felony
				convictions of the applicant under federal, state or local law;
(3) the applicant's past experience in the
				distribution of prescription drugs, including controlled substances;
(4) the furnishing by the applicant of false
				or fraudulent material in any application made in connection with prescription
				drug manufacturing or prescription drug distribution;
(5) suspension or revocation by federal,
				state, or local government of any license currently or previously held by the
				applicant for the manufacture or distribution of any drugs, including
				controlled substances;
(6)
				compliance with licensing requirements under previously granted licenses, if
				any;
(7) compliance with
				requirements to maintain or make available to the board or to federal, state,
				or local law enforcement officials those records required under this section;
				and
(8) any findings by the board
				that the applicant has violated or been disciplined by a regulatory agency in
				any state for violating and federal, state, or local laws relating to drug or
				device wholesale distribution;
(9)
				any other factors or qualifications the board considers relevant to and
				consistent with the public health and safety.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 36 - COMPOUNDED STERILE PREPARATIONS › Section 16.19.36.2 - SCOPE

Current through Register Vol. 35, No. 13, July 16, 2024
All facilities as defined in Paragraph (1), (2), (5) through
				  (11) and (15) of Subsection B of
				  61-11-14
				  NMSA 1978, and all persons or entities that own or operate, or are employed by
				  a facility for the purpose of providing pharmaceutical compounded sterile
				  preparations or services.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 36 - COMPOUNDED STERILE PREPARATIONS › Section 16.19.36.3 - STATUTORY AUTHORITY

Current through Register Vol. 35, No. 13, July 16, 2024
Paragraph (6) of Subsection A of Section
				  61-11-6
				  NMSA 1978 authorizes the board of pharmacy to provide for the licensing of all
				  places where dangerous drugs are stored, dispensed, distributed or administered
				  and for the inspection of their facilities and activities. Paragraph (7) of
				  Subsection A of
				  61-11-6
				  NMSA 1978 authorizes the board to enforce the provisions of all laws of the
				  state pertaining to the practice of pharmacy and the manufacture, production,
				  sale or distribution of drugs and their standards of strength and
				  purity.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 36 - COMPOUNDED STERILE PREPARATIONS › Section 16.19.36.5 - EFFECTIVE DATE

Current through Register Vol. 35, No. 13, July 16, 2024
June 28, 2014, unless a different date is cited at the end of
				  a section.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 36 - COMPOUNDED STERILE PREPARATIONS › Section 16.19.36.6 - OBJECTIVE

Current through Register Vol. 35, No. 13, July 16, 2024
The objective of Part 36 of Chapter 19 is to establish
				  standards to ensure that the citizens of New Mexico receive properly compounded
				  contaminant-free sterile preparations properly compounded in accordance with
				  all applicable USP/NF General Chapters numbered below 1000.