reglab/statecodes huggingface dataset:
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 9 - MINIMUM STANDARDS FOR MANUFACTURERS AND REPACKAGING FIRMS › Section 16.19.9.3 - STATUTORY AUTHORITY

Current through Register Vol. 35, No. 13, July 16, 2024
Section
				  61-11-6
				  A(6) NMSA 1978 directs the Board of Pharmacy to provide for the licensing of
				  drug manufacturers and for the inspection of their facilities and activities.
				  Section 61-11-6(A) NMSA 1978 authorizes the Board to enforce the provisions of
				  all state laws pertaining to the practice of pharmacy and the manufacture,
				  production, sale or distribution of drugs, cosmetics or poisons, including the
				  New Mexico Drug, Device and Cosmetic Act, Chapter 26, Article I NMSA 1978.
				  Pursuant to Section
				  26-1-18
				  of the Drug, Device and Cosmetic Act, the Board is authorized to promulgate
				  regulations for the efficient enforcement of the Act.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 9 - MINIMUM STANDARDS FOR MANUFACTURERS AND REPACKAGING FIRMS › Section 16.19.9.5 - EFFECTIVE DATE

Current through Register Vol. 35, No. 13, July 16, 2024
February 15, 1996, unless another date is specified at the
				  end of a section.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 9 - MINIMUM STANDARDS FOR MANUFACTURERS AND REPACKAGING FIRMS › Section 16.19.9.6 - OBJECTIVE

Current through Register Vol. 35, No. 13, July 16, 2024
The objective of Part 9 of Chapter 19 is to establish
				  standards for the safe and competent manufacture, packaging, repackaging and
				  distribution of drugs, including radioactive pharmaceuticals.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 9 - MINIMUM STANDARDS FOR MANUFACTURERS AND REPACKAGING FIRMS › Section 16.19.9.7 - DEFINITIONS

Current through Register Vol. 35, No. 13, July 16, 2024
For the purpose of defining Section
				  26-1-11
				  A(3) NMSA Comp. the following definitions apply:
A. "Manufacturer" means the steps in the
				preparation, propagation, processing or compounding of a drug - the making by
				chemical, physical, biological or other procedures of any articles which meet
				the definition of drugs and includes manipulation, sampling or control
				procedures resulting in the finished dosage form. Manufacture includes all the
				steps performed on the product itself, which do not affect intrinsically the
				safety, purity or potency of the product.
B. "Manufacturers" means the person or
				company who manufacturers a drug in its' finished dosage form.
C. "Packager" or "Packer" means a person or
				firm, other than a wholesaler, who distributes drugs.
D. "Distributor" means the original selling
				agent, other than a wholesaler, who distributes drugs.
E. "The finished dosage form" of a
				prescription drug is defined as that form of the drug which is or is intended
				to be dispensed or administered to the patient and requires no further
				manufacturing or processing other than packaging and labeling.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 9 - MINIMUM STANDARDS FOR MANUFACTURERS AND REPACKAGING FIRMS › Section 16.19.9.8 - MINIMUM STANDARDS

Current through Register Vol. 35, No. 13, July 16, 2024
A. The
				following minimum standards shall apply to all manufacturing establishments and
				repackaging firms for which licenses have been issued by the Board:
(1) All drugs and chemicals used in the
				manufacturing process or held for sale shall conform to the New Mexico Drug and
				Cosmetic Act and shall be stored, preserved and disposed of as prescribed by
				laws regulating the labeling and manufacture of drugs. When necessary, and/or
				according to label requirements, all drugs and chemicals which require
				refrigeration shall be stored and preserved under proper temperature.
(2) All manufacturers must conform to current
				good manufacturing practices as set forth in Title 21, CFR, Subsection 211.1 to
				211.208 inclusive. The definitions and interpretations contained in Section 201
				of the Federal Food and Drug Act shall be applicable.
(3) All manufacturers must conform to (1141)
				Packaging, Storage, and Distribution of Pharmacopeial Articles, the United
				States Pharmacopeia. These include the following stability protocols:
(4) Stability of manufactured dosage forms
				must be demonstrated by the manufacturer by the use if the methods adequate for
				the purpose. Monograph assays may be used for stability testing if they are
				stability-indicating (i.e., if they accurately differentiate between the intact
				drug molecules and their degradation products). Stability considerations should
				include not only the specific compendial requirements, but also changes in
				physical appearance of the product that would warn, users that the product's
				continued integrity is questionable.
(5) Stability studies on active substances
				and packaged dosage forms must be conducted by means of "real time", long-term
				tests at specific temperatures and relative humidities representing storage and
				shipping conditions experienced in the distribution chain of the climatic zones
				of the country or region of the world concerned. Labeling of the packaged
				active substance or dosage form shall reflect the effects of temperature,
				relative humidity, air, and light on its stability. Label temperature storage
				warnings will reflect both the results of the real-time storage tests and also
				allow for expected seasonal excursions of temperature during
				distribution.
(6) All persons in
				the distribution or dispensing chain shall comply with the manufacturers
				directions.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 9 - MINIMUM STANDARDS FOR MANUFACTURERS AND REPACKAGING FIRMS › Section 16.19.9.9 - LICENSURE OR REGISTRATION

Current through Register Vol. 35, No. 13, July 16, 2024
Wholesale distributor and manufacturer distributor or
				  manufacturer.
A. No manufacturer
				shipping dangerous drugs into New Mexico or who sells or distributes dangerous
				drugs in this state through any person or media, other than a wholesaler who
				has obtained a license, shall conduct the business of selling or distributing
				dangerous drugs without obtaining an out-of-state drug license from the
				Board.
B. Applications for an
				out-of-state drug distributor's license under this section shall be made on a
				form furnished by the Board of Pharmacy. The Board may require such information
				as it deems is reasonably necessary to carry out the purposes of this section.
				This requirement does not include the licensure of a parent corporation of a
				corporation or division.
C. The
				license fee shall be as specified in 16.19.12 NMAC, Fees, and shall be renewed
				annually before the last day of December each year.
D. No person acting as principal or agent
				(detail man) for any out-of-state manufacturer, wholesaler or distributor who
				has not obtained a license from the Board shall conduct the business of selling
				or distributing dangerous drugs within the state.
E. Any person acting as principal or agent
				for any manufacturer, wholesaler or distributor who is licensed by the Board
				and who possesses or distributes dangerous drugs, shall register as principal
				or agent for the licensed manufacturer, wholesaler or distributor.
F. Registration of persons under this section
				shall be made on a form furnished by the Board. The Board may require such
				information as it deems is reasonably necessary to carry out the purpose of
				this section, including, but not limited to, the name and address of the
				registrant and the name and address of the manufacturer whose drugs he is
				selling or distributing.
G. The
				Board may deny, revoke or suspend such person's registration for any violation
				of the State Drug Laws.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 9 - MINIMUM STANDARDS FOR MANUFACTURERS AND REPACKAGING FIRMS › Section 16.19.9.10 - LABELS

Current through Register Vol. 35, No. 13, July 16, 2024
Labels for legend drugs in package form shall conspicuously
				  state the name and place of business of the manufacturer of the finished dosage
				  form and the name and place of business of the packer or
				  distributor.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 9 - MINIMUM STANDARDS FOR MANUFACTURERS AND REPACKAGING FIRMS › Section 16.19.9.11 - FINISHED DOSAGE FORMS

Current through Register Vol. 35, No. 13, July 16, 2024
Where the manufacturer of the finished dosage form and the
				  packer or distributor are the same person, only the name and place of business
				  of such persons are required to be on the labels, no qualifying language is
				  necessary.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 9 - MINIMUM STANDARDS FOR MANUFACTURERS AND REPACKAGING FIRMS › Section 16.19.9.12 - FINISHED DOSAGE FORMS - QUALIFYING LANGUAGE

Current through Register Vol. 35, No. 13, July 16, 2024
Where the manufacturer of the finished dosage form and the
				  packer or distributor are different persons, the labels shall contain
				  qualifying language that states the connection such persons have with the
				  drugs: i.e., "Manufactured by ________, distributed by _________, "Manufactured
				  by ____________, for ___________", or other wording which adequately expresses
				  the facts.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 9 - MINIMUM STANDARDS FOR MANUFACTURERS AND REPACKAGING FIRMS › Section 16.19.9.13 - FINISHED DOSAGE FORMS - CORPORATE NAME

Current through Register Vol. 35, No. 13, July 16, 2024
In the case of a corporation, only the actual corporate name,
				  which may be preceded or followed by the name of the particular division of the
				  corporation shall be required. In the case of an individual partnership or
				  association, the name under which the business is conducted shall be
				  used.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 9 - MINIMUM STANDARDS FOR MANUFACTURERS AND REPACKAGING FIRMS › Section 16.19.9.14 - FINISHED DOSAGE FORMS - PLACE OF BUSINESS

Current through Register Vol. 35, No. 13, July 16, 2024
If a person manufactures, packs or distributes a drug at a
				  place other than his principle place of business, the label may state the
				  principle place of business in lieu of the actual place where such drug is
				  manufactured or packed or is to be distributed, unless such statement would be
				  misleading.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 10 - LIMITED DRUG CLINICS › Section 16.19.10.2 - SCOPE

Current through Register Vol. 35, No. 13, July 16, 2024
All public health clinics, industrial health clinics,
				  emergency medical services, and animal control clinics, and all individuals or
				  entities that own or operate, or are employed by, such clinics for the purpose
				  of providing pharmaceutical products and services.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 10 - LIMITED DRUG CLINICS › Section 16.19.10.3 - 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 the Board of Pharmacy to provide for the licensing of
				  industrial and public health clinics and for the inspection of their facilities
				  and activities. Pursuant to Paragraphs (6), (7), (12), and (13) of Subsection B
				  of Section
				  61-11-14
				  NMSA 1978, the Board is authorized to issue drug permits, as defined and
				  limited by Board regulation, for industrial health clinics, community health
				  clinics, animal control facilities, and wholesalers, retailers and distributors
				  of veterinary drugs. Subsection (A) of Section
				  26-1-16
				  NMSA 1978 prohibits the sale, disposal or possession of any dangerous drug
				  except by individuals and entities identified in the statute, including clinics
				  licensed by the Board.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 10 - LIMITED DRUG CLINICS › Section 16.19.10.5 - EFFECTIVE DATE

Current through Register Vol. 35, No. 13, July 16, 2024
February 15, 1996, unless a different date is cited at the
				  end of a Section or Paragraph. This Part reformatted for inclusion into the New
				  Mexico Administrative Code (NMAC) effective 2-15-96.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 10 - LIMITED DRUG CLINICS › Section 16.19.10.6 - OBJECTIVE

Current through Register Vol. 35, No. 13, July 16, 2024
The objective of Part 10 of Chapter 19 is to ensure safe and
				  competent maintenance, delivery and administration of drugs by emergency
				  medical services and in industrial, public health, and animal control clinic
				  settings.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 10 - LIMITED DRUG CLINICS › Section 16.19.10.7 - DEFINITIONS

Current through Register Vol. 35, No. 13, July 16, 2024
All terms defined in the Pharmacy Act or elsewhere in the
				  Board Regulations shall have the same meanings in this regulation unless
				  otherwise defined below:
A. "Clinic",
				means any facility where one or more licensed practitioners diagnose and treat
				patients, and where drugs are stored, dispensed, distributed or administered
				for the diagnosis and treatment of the facility's patients; provided that this
				definition shall not include the privately owned practice of any licensed
				practitioner or group of licensed practitioners exempt under Section
				61-11-22
				of the Pharmacy Act.
B. "Dispensing
				Unit", means a container or containers of a drug entity, either prepackaged
				(repackaged per Board requirements) or the manufacturer's original
				container(s), containing a quantity suitable for the prescribed treatment or
				condition.
C. "Distribute" means
				delivery of a dispensing unit (as defined in this section) by a licensed
				practitioner to a patient of the clinic by means other than
				dispensing.
D. "Drug Storage Area",
				means an area restricted to the storage, dispensing and distribution of
				dangerous drugs.
E. "Medical
				Records", means the medical information gathered and maintained for a clinic's
				patient, including but not restricted to the patients weight, height, sex,
				D.O.B., allergies, diagnosis and treatments.
F. "Mobile Narcotic Treatment Program" means
				a narcotic treatment program (NTP) operating from a motor vehicle, as defined
				in this section, that serves as a mobile component (conveyance) and is
				operating under the registration of the NTP, and engages in maintenance and/ or
				detoxification treatment with narcotic drugs in schedules II-V, at a location
				or locations remote from, but within the same State as, its registered
				location. Operating a mobile NTP is a coincident activity of an existing
				NTP.
G. Motor vehicle means a
				vehicle propelled under its own motive power and lawfully used on public
				streets, roads, or highways with more than three wheels in contact with the
				ground. This term does not include a trailer.
H. "Transfer", means the direct delivery,
				physically or electronically, of dangerous drug stock unopened containers,
				except samples, from a clinic or the clinic's supplier to a pharmacy to be
				dispensed by the pharmacy to patients of the clinic.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 10 - LIMITED DRUG CLINICS › Section 16.19.10.8 - MEDICAL STATIONS AND FIRST AID STATIONS

Current through Register Vol. 35, No. 13, July 16, 2024
A. The New Mexico Board of Pharmacy
				acknowledges the establishment of Medical Stations and First Aid Stations for
				employees in or of industrial plants and business organizations. In order to
				protect the people who utilize such facilities, laws and safeguards pertaining
				to drugs must be observed. Medications must occasionally be used and therefore
				require Board of Pharmacy supervision.
B. The variety and quantity of medications
				allowed at an Industrial Health Clinic must be kept to a minimum and must be
				only sufficient to meet the needs of the individual station.
C. The physician in charge of and responsible
				for the station must order the legend drugs to be used in such station. In
				order to purchase and stock any controlled substances, the responsible
				physician must obtain a separate controlled substance registration.
D. All legend drugs must be under lock when
				the nurse or physician is not in attendance. Extra precautions should be
				provided for security of controlled substances.
E. A record book indicating the following
				information shall be kept to account for the receipt and administration of all
				legend drugs:
(1) Date received
(2) Quantity received
(3) Date of administration
(4) Name of patient
(5) Name of medication
(6) Dosage administration
(7) Name of physician responsible for the
				order
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 10 - LIMITED DRUG CLINICS › Section 16.19.10.10 - ANIMAL CONTROL CLINICS

Current through Register Vol. 35, No. 13, July 16, 2024
A. The
				New Mexico Board of Pharmacy acknowledges the establishment of animal control
				clinics. In order to protect the people who utilize such clinics, laws and
				safeguards pertaining to drugs must be observed. Medications must occasionally
				be used and therefore require Board of Pharmacy supervision.
B. The veterinarian in charge of and
				responsible for the clinic must specify the dangerous drugs to be used in such
				clinic. In order to purchase and stock any controlled substances, the clinic
				must obtain a separate controlled substance registration to be issued under the
				name of the clinic.
C. All
				dangerous drugs must be under lock when the veterinarian or his designee is not
				in attendance. Extra precautions should be provided for security of controlled
				substances.
D. A record indicating
				the following information shall be kept to account for the administration of
				all dangerous drugs:
(1) Date of
				administration;
(2) Type of
				animal;
(3) Name of medication;
(4) Dosage administered;
(5) Name of veterinarian responsible for the
				order;
(6) Name of individual
				administering the dose.
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

Current through Register Vol. 35, No. 13, July 16, 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;
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 10 - LIMITED DRUG CLINICS › Section 16.19.10.12 - INPATIENT HOSPICE FACILITIES

Current through Register Vol. 35, No. 13, July 16, 2024
A.
				Licensure:
(1) All inpatient hospice
				facilities which maintain custody of patients' drugs, and such drugs are
				administered by the facilities' designated personnel shall obtain a custodial
				care facility license as described in 16.19.11.7.A or 7.B NMAC.
(2) All inpatient hospice facilities where
				dangerous drugs are acquired and maintained for administration, to patients of
				the facility shall obtain a limited drug permit as described in
				16.19.10.11(A).
(3) All inpatient
				hospice facilities holding a limited drug permit where controlled substances
				are maintained for administration from stock to patients of the facility shall
				obtain controlled substance registration as described in 16.19.20.8 NMAC
				through 16. 19.20.10 NMAC.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 11 - NURSING HOME DRUG CONTROL › Section 16.19.11.1 - ISSUING AGENCY

Current through Register Vol. 35, No. 13, July 16, 2024
Regulation and Licensing Department - Board of Pharmacy,
				  Albuquerque, NM, (505) 841-9102.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 11 - NURSING HOME DRUG CONTROL › Section 16.19.11.2 - SCOPE

Current through Register Vol. 35, No. 13, July 16, 2024
All nursing homes and custodial care facilities; all health
				  care professionals who provide pharmaceutical products or services, including
				  the ordering and administration of drugs, to patients in nursing homes and
				  custodial care facilities. Hospital based Skilled Nursing Facilities are not
				  subject to this regulation - See Part 7.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 11 - NURSING HOME DRUG CONTROL › Section 16.19.11.3 - 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 license nursing home drug
				  facilities and all places where dangerous drugs are dispensed or administered
				  and to provide for the inspection of their facilities and activities. Section
				  61-11-14.B(9)
				  NMSA 1978 directs the Board to issue drug custodial licenses for licensed
				  nursing homes and to adopt regulations that define and limit those
				  licenses.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 11 - NURSING HOME DRUG CONTROL › Section 16.19.11.5 - EFFECTIVE DATE

Current through Register Vol. 35, No. 13, July 16, 2024
December 15, 2002, 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 11 - NURSING HOME DRUG CONTROL › Section 16.19.11.6 - OBJECTIVE

Current through Register Vol. 35, No. 13, July 16, 2024
The objective of Part 11 of Chapter 19 is to establish
				  standards for the ordering, administration, maintenance and disposal of drugs
				  for patients in nursing homes, skilled nursing facilities, and long-term care
				  and custodial care facilities and to ensure that the facilities' pharmaceutical
				  services are organized and carried out for the benefit and safety of the
				  patients.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 11 - NURSING HOME DRUG CONTROL › Section 16.19.11.7 - DEFINITIONS

Current through Register Vol. 35, No. 13, July 16, 2024
A. Licensed Facility - Any facility, skilled nursing facility, intermediate care or any other upper level of care facility as defined by Health and Human Services Department that is required to maintain custody of patients drugs in a drug room, and such drugs are administered by the facilities' designated personnel.
B. Licensed Custodial Care Facility - Any facility or business, including non-profit entity which provides retirement care, mental care or other facility that provides extended health care to patients.
C. Consultant pharmacist - means a pharmacist who is responsible to the administrator of the facility and the Board of Pharmacy for the development of the drug storage and distribution and record keeping requirements of a licensed nursing home facility, and as further defined in 16.19.4.11 NMAC.
D. Designated agent - A licensed nurse, certified nurse practitioner, physician assistant, pharmacist or pharmacist clinician authorized by a practitioner and employed in a facility to whom the practitioner communicates a prescription drug order.
E. Prescription drug order - An order from a practitioner or a practitioner's designated agent to a pharmacist for a drug or device to be dispensed.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 11 - NURSING HOME DRUG CONTROL › Section 16.19.11.8 - MINIMUM STANDARDS

Current through Register Vol. 35, No. 13, July 16, 2024
A. MINIMUM
				STANDARDS FOR THE DISTRIBUTION, STORAGE, HANDLING AND RECORD KEEPING OF DRUGS:
(1)The pharmaceutical service shall be
				organized and maintained primarily for the beneft and safety of the
				patient.
(2) All medications
				administered to patients shall be by direct order of a physician, or other
				licensed practitioner, as defined in the Pharmacy Act,
				61-11-2
				P.
(3) The pharmaceutical service
				shall be under the direction of a registered pharmacist, who may be on a
				part-time or consultant basis.
(4)
				Policies relating to the control, distribution and administration of
				medications shall be developed by the pharmacist. Preparation of a written
				procedures manual shall be the responsibility of the pharmacist.
(5) An automatic stop-order policy shall be
				adopted to provide guidance in these instances where medications ordered are
				not specifcally limited as to time or number of doses.
(6) Adequate facilities to be provided for
				storage of medications. Proper labeling is required on each patient's
				medication container.
(7) Complete
				records - In addition to those records specifcally required by federal and
				state laws, records shall be maintained of the receipt, use, or disposition of
				medications. The receipt and destruction journal shall show:
(a) date;
(b) patient's name;
(c) pharmacy's name;
(d) name of drug;
(e) strength and dosage form;
(f) prescription number;
(g) quantity;
(h) initials of person accepting delivery;
				and
(i) inventory of drugs to be
				destroyed.
(8)
				Appropriate current drug reference sources shall be provided at the
				facility.
(9) In licensed nursing
				homes an emergency drug supply shall be maintained to be used in a medical
				emergency situation, contents and quantity to be determined by a physician,
				nursing director and the pharmacist of each institution. In licensed custodial
				care facilities an emergency drug supply may be used. This emergency drug
				supply shall be accessed only when licensed personnel are on duty. In licensed
				custodial care facilities without a 24-hour/365 day per year on-site nurse, the
				emergency drug tray shall not contain any controlled substances. Licensed
				custodial care facilities, with a 24-hour/365 day per year on-site nurse may
				use an emergency drug tray containing controlled substances. A list of the
				contents of the emergency drug supply shall be attached to the outside of the
				tray.
(10) Medication errors and
				drug reactions should be documented and a method of reporting shall be
				addressed in the pharmacy procedure manual.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 12 - FEES › Section 16.19.12.3 - STATUTORY AUTHORITY

Current through Register Vol. 35, No. 13, July 16, 2024
Section 30 -31-11 NMSA 1978 authorizes the board of pharmacy
				  ("board") to charge reasonable fees relating to the registration and control of
				  the manufacture, distribution and dispensing of controlled substances. Section
				  30-31B-6 NMSA 1978 authorizes the
				  board to charge reasonable fees for the registration and control of the
				  manufacture, possession, transfer and transportation of drug precursors.
				  Sections 61-11-12,
				  61-11-13, and
				  61-11-14 NMSA 1978 authorize the
				  board to charge, and limit the maximum charges for:
A. applications for registration and renewal
				of registration as a pharmacist, pharmacist intern, or pharmacy technician;
				and
B. applications for the
				registration of retail pharmacies, wholesale drug distributors, nonresident
				pharmacies, drug manufacturers, hospital pharmacies, drug rooms, nursing homes,
				industrial or public health clinics, the department of health clinics and
				health facilities, home care services, wholesalers, retailers and distributors
				of legend-bearing veterinary drugs, medicinal gas repackagers, medicinal gas
				sellers, outsourcing facilities, repackagers, and third party logistics
				providers. Section
				61-1-34 NMSA 1978 authorizes the
				board to waive license fees for the first three years for military service
				members, spouses, dependents, and veterans where the license is issued by
				reciprocity.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 12 - FEES › Section 16.19.12.5 - EFFECTIVE DATE

Current through Register Vol. 35, No. 13, July 16, 2024
February 15, 1996, unless a different date is cited at the
				  end of a Section or Paragraph. This Part reformatted for inclusion into the New
				  Mexico Administrative Code (NMAC) effective 2-15-96.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 12 - FEES › Section 16.19.12.6 - OBJECTIVE

Current through Register Vol. 35, No. 13, July 16, 2024
The objective of Part 12 of Chapter 19 is to ensure uniform
				  imposition and collection of fees that conform to statutory requirements for
				  individuals and entities that provide pharmaceutical products and
				  services.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 12 - FEES › Section 16.19.12.8 - FEES

Current through Register Vol. 35, No. 13, July 16, 2024
All fees shall be paid in advance of the issuance of any
				  license, permit, certificate or replacement of a certificate and shall not be
				  refundable.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 12 - FEES › Section 16.19.12.9 - REGISTRATION FEES

Current through Register Vol. 35, No. 13, July 16, 2024
A. Registration by examination $200.00
B. Registration by reciprocity $200.00
C. Registration as an intern $25.00
D. Registration as a pharmacy technician $25.00
E. Waiver of registration fees: The board of pharmacy waives the registration fee set forth in regulation 16.19.12.9 for change of duty location to New Mexico for individuals who are currently serving in the United States military, and for those service member spouses.
F. Registration fees are waived for United States military service members, spouses (includes surviving spouse of a member who at the time of member's death was serving on active duty), dependent children, and veterans who are applying for pharmacist licensure by reciprocity.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 12 - FEES › Section 16.19.12.10 - CERTIFICATE OF REGISTRATION OR REPLACEMENT

Current through Register Vol. 35, No. 13, July 16, 2024
Any replacement of a certificate shall be accompanied by a
				  notarized statement of the reason or cause of the loss of the original, or by
				  the original certificate to be replaced in case of damage or name change. All
				  replacement certificates will be given the same number as the original
				  certificate and will be marked "DUPLICATE".
A. Certificate of registration
				$20.00
B. Replacement of a
				certificate of registration $20.00
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 12 - FEES › Section 16.19.12.11 - CERTIFICATION OF GRADES AND INTERNSHIP HOURS

Current through Register Vol. 35, No. 13, July 16, 2024
A. Certification of Grades $10.00
B. Certification of Internship Hours
				$10.00
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 12 - FEES › Section 16.19.12.12 - LICENSE/REGISTRATION RENEWAL

Current through Register Vol. 35, No. 13, July 16, 2024
A.
				Pharmacist license renewal for active $200.00 bi-ennially
B. Pharmacist license renewal for in-active
				$70.00 bi-ennially
C. Intern
				renewal $25.00 per year
D.
				Duplicate license for interns and pharmacists $10.00
E. Controlled substance registration $180.00
				tri-ennially
A locum tenens practitioner may apply for an initial
				  registration which expires no more than one year after date of issuance, and
				  this registration fee shall be $60.00. The board may issue a registration for a
				  time period determined by the board and shorter than three years if it is
				  consistent with the public health and safety.
F. Duplicate license for controlled substance
				$10.00
G. Pharmacy technician
				renewal $30.00 bi-ennially
H.
				Pharmacist clinician $70.00 bi-ennially
I. Pharmacist license renewal for active
				pharmacists with 50 or more years of service $70.00 bi-ennially
J. Note: Waiver of license renewal fees: The
				board of pharmacy waives the renewal fee set forth in regulation 16.19.12.12
				for individuals who are currently serving in the United States military in an
				active war zone or who serve in direct support of operation in active war
				zones.
K. Initial renewal fees are
				waived for United States military service members, spouses (includes surviving
				spouse of a member who at the time of member's death was serving on active
				duty), dependent children, and veterans, who obtained pharmacist licensure by
				reciprocity.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 12 - FEES › Section 16.19.12.13 - LICENSE FEES

Current through Register Vol. 35, No. 13, July 16, 2024
A. Drug manufacturer $1000.00 bi-ennially
B. Wholesale drug distributor $1000.00 bi-ennially
C. Drug manufacturer/re-packager $1000.00 bi-ennially
D. Re-packager $1000.00 bi-ennially
E. Retail pharmacy $300.00 bi-ennially
F. Hospital pharmacy $300.00 bi-ennially
G. Nonresident pharmacy $400.00 bi-ennially
H. Nonresident pharmacy, sterile compounding $600.00 bi-ennially
I. Seller or dispenser of contact lenses $200.00 bi-ennially
J. Dangerous drug research $200.00 bi-ennially
K. Drug warehouse $200.00 bi-ennially
L. Duplicate license or permit(for all types) $10.00 per each request
M. Letter of good standing, verification, and certification $10.00 per each request
N. Outsourcing facility $2000.00 bi-ennially
O. Third party logistics provider $1000.00 bi-ennially
P. Medical gas repackager, or seller $200 bi-ennially
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 12 - FEES › Section 16.19.12.14 - DRUG ROOM PERMIT

Current through Register Vol. 35, No. 13, July 16, 2024
A. Drug room
				permit in adult shelter care or custodial care facility:
(1) 10 or fewer beds: $100.00 bi-ennially
(2) 11 or more beds: $200.00
				bi-ennially
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 12 - FEES › Section 16.19.12.15 - CLINIC LICENSE FEES

Current through Register Vol. 35, No. 13, July 16, 2024
A.
				Class A, B, C, or E Clinic $300.00 bi-ennially
B. Class D clinic $50.00
				bi-ennially
C. Animal control
				clinic $100.00 bi-ennially
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 12 - FEES › Section 16.19.12.17 - LIMITED VETERINARY DRUG RETAIL OR WHOLESALE LICENSE

Current through Register Vol. 35, No. 13, July 16, 2024
Limited veterinary drug retail or wholesale license shall be:
				  $150.00 per year
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 12 - FEES › Section 16.19.12.18 - INSPECTION FEE

Current through Register Vol. 35, No. 13, July 16, 2024
A. Initial
				inspection or reinspection $150.00
B. Pre-licensing inspection for Class D
				clinic $30.00
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 12 - FEES › Section 16.19.12.20 - REINSTATEMENT FEES

Current through Register Vol. 35, No. 13, July 16, 2024
Any person whose board registration or license has expired
				  and who seeks reinstatement of the certificate of license must pay the
				  following reinstatement fee in addition to all delinquent renewal fees:
A. Pharmacists $25.00
B. All other licenses issued by the board of
				pharmacy under the Pharmacy Act and the Drug Precursor Act including, but not
				limited to, licenses for retail pharmacy, non-resident pharmacy, wholesale drug
				distributor, drug manufacturer, hospital pharmacy, drug room, nursing home,
				clinic facility, wholesalers, retailers or distributors of veterinary drugs,
				and drug precursor, twenty-five percent of the license renewal fee not to
				exceed $100.00
C. Controlled
				substance registrations are exempt from reinstatement fees. Delinquent renewal
				fees shall not exceed $180.00.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 12 - FEES › Section 16.19.12.21 - EMS LICENSURE FEES

Current through Register Vol. 35, No. 13, July 16, 2024
Annual license fees shall be paid to the Board according to
				  the following schedule:
A. The home
				office or headquarters shall pay $50.00;
B. Every additional location shall pay
				$25.00.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 13 - TEMPORARY BUSINESS LICENSES › Section 16.19.13.1 - ISSUING AGENCY

Current through Register Vol. 35, No. 13, July 16, 2024
Regulation and Licensing Department Board of Pharmacy, 1650
				  University Blvd, NE - Ste. 400B, Albuquerque, NM 87102, (505)
				  841-9102.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 13 - TEMPORARY BUSINESS LICENSES › Section 16.19.13.2 - SCOPE

Current through Register Vol. 35, No. 13, July 16, 2024
All business entities that possess, administer, dispense
				  and/or distribute prescription drugs and/or devices for the purpose of
				  providing pharmaceutical products and services.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 13 - TEMPORARY BUSINESS LICENSES › Section 16.19.13.3 - STATUTORY AUTHORITY

Current through Register Vol. 35, No. 13, July 16, 2024
Section
				  61-11-6.B.(1)
				  NMSA 1978 authorizes the Board to delegate its authority to the Executive
				  Director to issue temporary licenses as provided in Section
				  61-11-14.H.
				  NMSA 1978.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 13 - TEMPORARY BUSINESS LICENSES › Section 16.19.13.6 - OBJECTIVE

Current through Register Vol. 35, No. 13, July 16, 2024
To expedite the licensure of business entities providing
				  pharmaceutical products and services. Temporary licenses shall only be issued
				  after the applicant has completed a deficiency free facility
				  inspection.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 13 - TEMPORARY BUSINESS LICENSES › Section 16.19.13.7 - DEFINITIONS

Current through Register Vol. 35, No. 13, July 16, 2024
All terms defined in the Pharmacy Act or elsewhere in the
				  Board regulations shall have the same meaning in this regulation unless
				  otherwise defined below:
A. Deficiency
				Free Inspection means compliance with all Board pre-licensing inspection
				requirements.
B.
				[Reserved]
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 13 - TEMPORARY BUSINESS LICENSES › Section 16.19.13.8 - PROCEDURE FOR TEMPORARY LICENSURE OF BUSINESS ENTITIES THAT POSSESS, ADMINISTER, DISPENSE AND/OR DISTRIBUTE PRESCRIPTION DRUGS AND/OR DEVICES

Current through Register Vol. 35, No. 13, July 16, 2024
A. Prior to
				issuance of a permanent license, an applicant may apply once, for each
				location, for a temporary license. The applicant shall submit required
				application and fee to the Board office.
B. After preliminary approval of the
				application, the applicant shall submit a "Request for Inspection" and the
				inspection fee, where applicable, a minimum of fourteen days in advance of the
				requested date for inspection.
C.
				Upon receipt of a deficiency free inspection report the Executive Director may
				issue a temporary facility license for this location.
D. The Board shall review the license
				application and the inspection report at its next meeting and shall cause a
				license to be issued or denied in accordance with the Uniform Licensing Act
				61-1-1 to
				61-1-33 NMSA
				1978.
E. The temporary license
				shall expire at the close of business on the last day of the next regular Board
				meeting.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 14 - DEVICES; MEDICAL GAS REPACKAGERS AND SELLERS › Section 16.19.14.2 - SCOPE

Current through Register Vol. 35, No. 13, July 16, 2024
All individuals and entities subject to the New Mexico Drug,
				  Device and Cosmetic Act, Chapter 26, Article I NMSA 1978.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 14 - DEVICES; MEDICAL GAS REPACKAGERS AND SELLERS › Section 16.19.14.3 - STATUTORY AUTHORITY

Current through Register Vol. 35, No. 13, July 16, 2024
Paragraph 7 of Subsection A of Section
				  61-11-6 NMSA 1978 authorizes the
				  Board to enforce the provisions of all state laws pertaining to the practice of
				  pharmacy and the manufacture, production, sale or distribution of drugs,
				  cosmetics or poisons, including the New Mexico Drug, Device and Cosmetic Act.
				  Paragraphs 18 and 19 of Subsection B of Section
				  61-11-14 authorize the Board to
				  license and otherwise establish minimum standards for medical gas sellers and
				  repackagers. Section
				  26-1-18 of the Drug, Device and
				  Cosmetic Act authorizes the Board to promulgate regulations for the efficient
				  enforcement of the Act.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 14 - DEVICES; MEDICAL GAS REPACKAGERS AND SELLERS › Section 16.19.14.5 - EFFECTIVE DATE

Current through Register Vol. 35, No. 13, July 16, 2024
February 15, 1996, unless a different date is cited at the
				  end of a Section or Paragraph. This Part reformatted for inclusion into the New
				  Mexico Administrative Code (NMAC) effective 2-15-96.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 14 - DEVICES; MEDICAL GAS REPACKAGERS AND SELLERS › Section 16.19.14.6 - OBJECTIVE

Current through Register Vol. 35, No. 13, July 16, 2024
The objective of Part 14 of Chapter 19 is to establish
				  mandatory controls and performance standards for health care devices so as to
				  minimize the risk of injury from the distribution and use of adulterated or
				  misbranded devices, and to establish standards for the repackaging and selling
				  of medical gases, so as to minimize the risk of injury from the distribution
				  and use of adulterated or misbranded medical gases.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 14 - DEVICES; MEDICAL GAS REPACKAGERS AND SELLERS › Section 16.19.14.7 - DEFINITIONS

Current through Register Vol. 35, No. 13, July 16, 2024
A.
"Device",
as used in the New Mexico Drug and Cosmetic Act, is any
				health care product that does not achieve any of its principal intended purpose
				through chemical action within or on the body of man or other animal and which
				is not dependent upon being metabolized for achievement of any of its principal
				intended purposes.
B.
"Board"
means the New Mexico board of pharmacy.
C.
"Distribution of medical
				gases"
means the distribution of medical gas, to persons other than
				consumers or patients.
D.
"Drug order"
means a prescription drug order issued by a licensed
				prescriber for medical gas.
E.
"FDA"
means the United States Food and Drug
				Administration.
F.
"Federal
				Act"
means the Federal Food, Drug and Cosmetic Act.
G.
"Medical gas"
means:
(1) a drug that is manufactured or stored in
				a liquefied, nonliquefied, or cryogenic state and is administered as a gas;
				and
(2) that is labeled for medical
				use in compliance with federal law and is otherwise a designated medical gas as
				defined at 21 U.S.C. Section
				360dd d(1) of the Federal Act, including each
				of the following that meets the standards set forth in an official compendium:
				oxygen, nitrogen, nitrous oxide, carbon dioxide, helium, and medical
				air.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 14 - DEVICES; MEDICAL GAS REPACKAGERS AND SELLERS › Section 16.19.14.8 - CLASSIFICATION OF DEVICES

Current through Register Vol. 35, No. 13, July 16, 2024
Three regulatory classes are established based on the extent
				  of control necessary to ensure safety and effectiveness of each device:
A. Class I -- General Controls
(1) prohibiting adulteration or
				misbranding
(2) requiring federal
				registration and listing by the manufacturer
(3) requiring notification of risks, repairs,
				replacement or refund
(4)
				requirement restricting sale, distribution or use
(5) requirement with respect to good
				manufacturing practices, record keeping, reports and inspections
(6) authority to ban the device
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 14 - DEVICES; MEDICAL GAS REPACKAGERS AND SELLERS › Section 16.19.14.9 - ADULTERATION

Current through Register Vol. 35, No. 13, July 16, 2024
A device may be considered to be adulterated:
A. It is subject to a performance standard
				and does not comply with all requirements of such standard.
B. Class II device FDA pre-market approval is
				not completed.
C. It is a banned
				device.
D. It is in violation of
				good manufacturing practice requirements.
E. It fails to comply with the IDE
				(Investigational Device Exemption) protocol.