reglab/statecodes huggingface dataset:
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 6 - PHARMACIES › Section 16.19.6.29 - REMOTE PHARMACY TECHNICIAN DATA ENTRY SITES

Current through Register Vol. 35, No. 13, July 16, 2024
A. General requirements.
(1) A New Mexico licensed pharmacy located in
				New Mexico may employ one or more certifed pharmacy technicians for the purpose
				of data input in remote practice sites provided that all security requirements
				are met.
(2) All pharmacy
				technicians employed to work at a remote data entry practice site must be
				registered as a certifed pharmacy technician with the board and have a minimum
				of one year experience performing data entry functions as a certifed pharmacy
				tech.
(3) All remote pharmacy
				technician data entry sites will operate under a New Mexico licensed pharmacy
				located in New Mexico under the authority of its
				pharmacist-in-charge.
(4) No drug
				inventory shall be kept at any remote pharmacy technician data entry site and
				no dispensing shall take place from a remote pharmacy technician data entry
				site.
(5) All remote pharmacy
				technician data entry sites will have a procedure for identifying the pharmacy
				technician and the pharmacist responsible for each aspect of the prescription
				preparations.
(6) All remote
				pharmacy technician data entry sites will have quality monitoring and
				improvement programs in place.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 6 - PHARMACIES › Section 16.19.6.30 - REPACKAGING AND DISTRIBUTION BY A PHARMACY

Current through Register Vol. 35, No. 13, July 16, 2024
A. Scope: This section applies only to repackaging by a pharmacy licensed by the board under the conditions specified in this section.
B. Definitions as used in this section:
(1)
"administer"
means the direct application of a drug to the body of a patient or research subject by injection, inhalation, ingestion or any other means as a result of an order of a licensed practitioner;
(2)
"board"
means the New Mexico Board of Pharmacy;
(3)
"distribute"
means the delivery of a drug or device other than by administering or dispensing;
(4)
"finished drug product"
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;
(5)
"FD&C Act"
means the Federal Food Drug and Cosmetic Act;
(6)
"repackaging"
means the of taking a finished drug product from the container in which it was distributed by the original manufacturer and placing it into a different container without further manipulation of the drug, excluding:
(a) placing medication in a different container to dispense directly to the patient pursuant to a patient-specific prescription;
(b) removing a drug product from the original container at the point of care for immediate administration to a single patient after receipt of a valid patient-specific prescription or order for that patient.
(7)
"USP"
means United States Pharmacopoeia;
(8)
"USP standards"
means standards published in the current official United States pharmacopoeia-national formulary.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 7 - HOSPITAL PHARMACIES › Section 16.19.7.3 - 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
				  hospital pharmacies and the drug rooms of hospitals and the inspection of their
				  facilities and activities.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 7 - HOSPITAL PHARMACIES › Section 16.19.7.5 - EFFECTIVE DATE

Current through Register Vol. 35, No. 13, July 16, 2024
August 16, 1999, unless a later date is cited at the end of a
				  Section or Paragraph.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 7 - HOSPITAL PHARMACIES › Section 16.19.7.6 - OBJECTIVE

Current through Register Vol. 35, No. 13, July 16, 2024
The objective of Part 7 of Chapter 19 is to establish
				  standards for the safe and competent delivery of quality pharmaceutical
				  care.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 7 - HOSPITAL PHARMACIES › Section 16.19.7.8 - LEADERSHIP

Current through Register Vol. 35, No. 13, July 16, 2024
A. There shall be a
				pharmacist-in-charge of the hospital pharmacy. The pharmacist in charge may be
				employed part-time or full-time as the activity of service requires. When
				services are provided on a part-time basis, the pharmacist-in-charge or
				designated pharmacist shall visit the facility at least every 72 hours.
				Visitation schedules exceeding 72 hours must request Board approval.
B. The pharmacist-in-charge shall be assisted
				by an adequate number of competent and qualified personnel.
C. Written job descriptions for all
				categories of pharmacy personnel shall be prepared and revised as
				necessary.
D. A pharmacy policy and
				procedure manual shall be prepared by the pharmacist-in-charge and readily
				available. The manual shall be reviewed annually for the purpose of
				establishing its consistency with current hospital practices and the process
				documented. A copy of this manual shall be submitted to the Board or its agent
				for review and approval at the time of the hospital license application. Any
				subsequent changes shall be reviewed by the Board or its agent.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 7 - HOSPITAL PHARMACIES › Section 16.19.7.9 - FACILITIES

Current through Register Vol. 35, No. 13, July 16, 2024
A. The hospital
				pharmacy shall be enclosed and locked if a pharmacist is not present in the
				facility. Adequate security systems shall be maintained and be consistent with
				the security plan of the facility.
B. The pharmacist-in-charge shall control
				access to the pharmacy and develop an emergency access procedure that may
				include the following situations or conditions:
(1) The hospital administrator or designee
				may possess a key to the pharmacy for emergency access.
(2) For the purposes of withdrawing limited
				doses of a drug for administration in emergencies when the pharmacy is closed,
				if the drugs are not available in floor or emergency drug supplies, the
				following is applicable:
(a) Only one
				designated licensed nurse per shift may remove drugs from the pharmacy. The
				quantity of drugs shall not exceed the quantity needed to last until the
				pharmacist is in the facility:
(b)
				A record shall be made at the time of withdrawal by the authorized person
				removing the drugs. The record shall contain the following:
(i) name of patient;
(ii) name of drug, strength, and dosage
				form;
(iii) dose
				prescribed;
(iv) quantity
				taken;
(v) time and date;
				and
(vi) signature (first initial
				and last name or full signature) or electronic signature of person making the
				withdrawal.
(c) The
				original or direct copy of the medication order may substitute for such record,
				providing the medication order meets all of the requirements of Subparagraph
				(b) of Paragraph (2) of Subsection (B) of
				16.19.7.9
				NMAC (record).
(d) The nurse
				withdrawing the drug shall place upon the record of withdrawal an example of
				the medication removed.
(e) An
				electronic record of the withdrawal is required when the nurse is withdrawing
				more than a 72 hour supply.
(f) The
				pharmacist shall verify the withdrawal after a reasonable interval, but in no
				event may such interval exceed 72 hours from time of withdrawal. Verification
				may be accomplished electronically from a remote site, if approved by the
				board.
(g) A drug regimen review,
				pursuant to a new medication order, will be conducted by a pharmacist either
				on-site or by electronic transmission within 24 hours of the new
				order.
(h) Another duly registered
				pharmacy may supply medications pursuant to a patient specific medication order
				provided:
(i) supplying pharmacy is licensed
				in this state;
(ii) supplying
				pharmacist is licensed in this state;
(iii) all pharmacy preparations of sterile
				products (including total parenteral nutrition and chemotherapy) shall be
				performed in accordance with board of pharmacy 16.19.36 NMAC.
(3) The
				pharmacist-in-charge or designated pharmacist, intern or technician may
				prepackage drugs for emergency withdrawal.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 7 - HOSPITAL PHARMACIES › Section 16.19.7.10 - PHARMACY SERVICE UNIT

Current through Register Vol. 35, No. 13, July 16, 2024
A. A
				pharmacy service unit:
(1) is a separate
				entity from the central hospital pharmacy, within the same physical
				building;
(2) provides limited
				and/or specialized inpatient pharmacy services with a minimum of 100 square
				feet;
(3) has the necessary space,
				references and equipment to perform the pharmacy service to be
				provided.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 7 - HOSPITAL PHARMACIES › Section 16.19.7.11 - DRUG DISTRIBUTION AND CONTROL

Current through Register Vol. 35, No. 13, July 16, 2024
A. In hospitals where there is not a
				pharmacy, prelabeled, prepackaged medications shall be stored in and
				distributed from a drug storage area or automated medication management system,
				which is under the supervision of a pharmacist.
B. The pharmacist-in-charge shall have the
				responsibility for the procurement and storage of all drugs.
C. All medications, with the exception of
				those for emergency use, shall be issued for inpatients use pursuant to the
				review of the physician's order or direct copy thereof, prior to dispensing. If
				the pharmacy is closed when the order is written, the pharmacist shall review
				the order within 24 hours.
D. A
				medication profile for all inpatients and outpatients shall be maintained and
				used. The medication profile shall serve as the distribution record for
				inpatient medications. Dangerous drug distribution records, for inpatient use,
				must include the following information:
(1)
				the patient's name and room (or bed) number;
(2) the name, strength, quantity and dosage
				form of the drug distributed;
(3)
				the name of the technician filling the drug order and pharmacist responsible
				for checking the technician's work; or
(4) the name of the pharmacist or pharmacist
				intern filling the drug order;
(5)
				the date filled; and
(6) the date
				and amount of unwanted/ unused drug returned to the pharmacy stock;
(7) records for schedule II controlled
				substances must be kept separate; and
(8) schedule III-V must be kept separate or
				if stored with non-controlled records, readily retrievable.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 7 - HOSPITAL PHARMACIES › Section 16.19.7.12 - DRUG INFORMATION

Current through Register Vol. 35, No. 13, July 16, 2024
A. The
				pharmacist-in-charge is responsible for provision of drug information to the
				staff and patients of the healthcare facility. The pharmacist-in-charge shall
				be responsible for providing in-service education to the facility's
				professional staff. In-service activities shall be documented.
B. The pharmacist-in-charge is responsible
				for maintaining up-to-date reference materials or electronic access to
				reference publications commensurate with the scope of practice. At a minimum,
				these references will include the current editions of:
(1) a drug interactions text;
(2) an injectable drug text;
(3) a general drug information text;
				and
(4) New Mexico Pharmacy Law and
				Rules and Regulations and all available revisions.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 7 - HOSPITAL PHARMACIES › Section 16.19.7.13 - ASSURING RATIONAL DRUG THERAPY

Current through Register Vol. 35, No. 13, July 16, 2024
A. The pharmacist in conjunction with
				practitioners, nurses and other professional staff shall develop a procedure
				for the review and reporting of significant adverse drug reactions and
				medication errors. These events shall be reported to the prescribing
				practitioner and the appropriate hospital quality assurance committee such as
				the Pharmacy and Therapeutics Committee or its equivalent..
B. Clinical information about patients must
				be available and accessible to the pharmacist for use in daily practice
				activities.
C. The pharmacist shall
				review each medication order for safety and appropriateness and communicate
				with the prescriber when adjustments may be necessary. Suggested changes made
				to the prescriber must be documented.
D. A documented medication-use-measurement
				program, developed shall be in place to evaluate the medication-use-process of
				prescribing, dispensing, administering and monitoring.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 7 - HOSPITAL PHARMACIES › Section 16.19.7.14 - RESEARCH

Current through Register Vol. 35, No. 13, July 16, 2024
A. The pharmacist
				shall conduct, participate in and support medical and pharmaceutical research
				appropriate to the goals, objectives and resources of the facility.
B. There shall be a pharmacist member on the
				facility's Institutional Review Board, or its equivalent. The pharmacist shall
				ensure that policies and procedures for the appropriate use of investigational
				drugs are established and followed.
C. A copy of the research protocol for a
				study involving investigational drugs and the facility's patients, shall be
				provided to the pharmacist. A copy of drug protocols shall be maintained in the
				pharmacy of all active investigational drug studies and similar research
				projects involving drugs in which the facility's patients are
				participants.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 7 - HOSPITAL PHARMACIES › Section 16.19.7.15 - IN-HOUSE CLINICS

Current through Register Vol. 35, No. 13, July 16, 2024
In-house clinics owned and operated by the institution must
				  meet regulations set forth in Part 10 "Limited Drug Clinics" and Part 4
				  "Pharmacists". The clinic may operate under the license of the hospital
				  pharmacy and is not required to obtain a separate license or permit from the
				  Board.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 7 - HOSPITAL PHARMACIES › Section 16.19.7.17 - INPATIENT HOSPITAL PHARMACY LIMITED DISPENSING, HOSPITALIZATION DISCHARGE

Current through Register Vol. 35, No. 13, July 16, 2024
A. In order to
				improve continuity of care by avoiding temporary disruption in a patient's
				prescribed medication regimen upon discharge from hospitalization, and to
				decrease medication waste (as in the case of a partially used multidose
				container, such as an inhaler), dispensing by a pharmacist in a hospital
				pharmacy not otherwise licensed as a retail pharmacy may occur under the
				conditions of this section.
B. A
				prescription or order is issued by a licensed practitioner of the hospital to
				be dispensed to the patient upon discharge. If not specified in the
				prescription or order, the pharmacist is responsible for obtaining and
				documenting any additional information needed for dispensing, including
				directions for use and quantity. The prescription or order may not be refilled,
				or transferred.
C. Naloxone for
				rescue use may be dispensed to the patient upon discharge pursuant to standing
				order, in accordance with Section
				24-23-1
				NMSA 1978.
D. The medication is not
				a controlled substance.
E. The
				dispensing label shall include all information as required in Paragraph (4) of
				Subsection (L) of
				16.19.7.11
				NMAC, and any other information required by state or federal law.
F. Responsibilities of pharmacist and
				pharmacist intern shall be fulfilled in accordance with
				16.19.4.16
				NMAC.
(1) Patient counseling shall be in
				person, whenever practicable, or by telephone.
(2) If the pharmacist is absent at the time
				of patient discharge, the patient shall be provided written information when
				appropriate on side effects, interactions, and precautions concerning the drug
				or device provided. Written information may be printed or electronic,
				consistent with patient preference.
(3) The pharmacy phone number shall be made
				available to patients for consultation.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 8 - WHOLESALE PRESCRIPTION DRUG DISTRIBUTION › Section 16.19.8.2 - SCOPE

Current through Register Vol. 35, No. 13, July 16, 2024
All individuals and entities engaged in the wholesale
				  distribution of prescription drugs, including, own-label distributors,
				  private-label distributors, jobbers, brokers, manufacturer's warehouses,
				  distributor's warehouses, chain drug warehouses, wholesale drug warehouses,
				  independent wholesale drug traders and retail pharmacies that conduct wholesale
				  distribution; third-party logistics providers; manufacturers and
				  repackagers.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 8 - WHOLESALE PRESCRIPTION DRUG DISTRIBUTION › Section 16.19.8.3 - STATUTORY AUTHORITY

Current through Register Vol. 35, No. 13, July 16, 2024
Paragraph (6) of Subsection A of Section
				  61-11-6
				  NMSA 1978 directs the board of pharmacy to provide for the licensing of drug
				  manufacturers, repackagers and wholesale drug distributors and for the
				  inspection of their facilities and activities. 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, 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 8 - WHOLESALE PRESCRIPTION DRUG DISTRIBUTION › Section 16.19.8.5 - EFFECTIVE DATE

Current through Register Vol. 35, No. 13, July 16, 2024
November 28, 2017, 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 8 - WHOLESALE PRESCRIPTION DRUG DISTRIBUTION › Section 16.19.8.6 - OBJECTIVE

Current through Register Vol. 35, No. 13, July 16, 2024
The objective of Part 8 of Chapter 19 is to implement the
				  Federal Food, Drug and Cosmetic Act, 21 United States Code (U.S.C.) 351 et
				  seq., as amended by the Drug Supply Chain Security Act of 2013 (
				  Pub. L.
				  113-54 ), by providing minimum standards, terms
				  and conditions for the licensing by the board of wholesale distributors,
				  third-party logistics providers and repackagers; and by replicating the federal
				  requirements relating to product tracing, identification and
				  verification.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 8 - WHOLESALE PRESCRIPTION DRUG DISTRIBUTION › Section 16.19.8.7 - DEFINITIONS

Current through Register Vol. 35, No. 13, July 16, 2024
A.
"Adulterated"
a drug or device shall be deemed to be adulterated
				if it:
(1) consists in whole or part of any
				filthy, putrid, or decomposed substance;
(2) has been produced, prepared, packed or
				held under unsanitary conditions whereby it may have been contaminated with
				filth, or whereby it may have been rendered injurious to health;
(3) is a drug and the methods used in or the
				facilities of controls used for its manufacture, processing, packing or holding
				do not conform to or are not operated or administered in conformity with
				current good manufacturing practice to assure that such drug meets the
				requirements of the New Mexico Drug, Device and Cosmetic Act (this article) as
				to safety and has the identity and strength and meets the quality and purity
				characteristics which purports or is represented to possess;
(4) is a drug and its container is composed
				in whole or part of any poisonous or deleterious substance which may render the
				contents injurious to health;
(5)
				is a drug and it bears or contains for purposes of coloring only a color
				additive which is unsafe within the meaning of the Federal Act or it is a color
				additive the intended use of which in drugs is for the purpose of coloring only
				and is unsafe within the meaning of the Federal Act;
(6) purports to be or is represented as a
				drug the name of which is recognized in an official compendium and its strength
				differs from or its quality or purity falls below the standard set forth in
				such compendium; such determination as to strength, quality and purity shall be
				made in accordance with the tests or methods of assay set forth in such
				compendium or in the absence of or inadequacy of such rests or methods of
				assay, those prescribed under the authority of the Federal Act; no drug defined
				in an official compendium shall be deemed to be adulterated under this
				paragraph because it differs from the standard of strength, quality or purity
				therefore set forth if such standard is plainly stated on its label; whenever a
				drug is recognized both in the United States pharmacopoeia and the homeopathic
				pharmacopoeia of the United States it shall be subject to the requirements of
				the United States pharmacopoeia unless it is labeled and offered for sale as a
				homeopathic drug, in which case it shall be subject to the provisions of the
				homeopathic pharmacopoeia of the United States and not those of the United
				States pharmacopoeia;
(7) is not
				subject to the provisions of Paragraph (6) of this subsection and its strength
				differs from or its purity or quality falls below that which it purports or is
				represented to possess;
(8) is a
				drug and any substance has been mixed or packed therewith so as to reduce its
				quality or strength or substituted wholly or in part therefore.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 8 - WHOLESALE PRESCRIPTION DRUG DISTRIBUTION › Section 16.19.8.8 - WHOLESALE DRUG DISTRIBUTOR LICENSING REQUIREMENTS

Current through Register Vol. 35, No. 13, July 16, 2024
A. Every wholesale drug distributor, wherever
				located, who engages in wholesale distribution into, out of, or within this
				state must be licensed by the board in accordance with the laws and regulations
				of this state before engaging in wholesale distribution of prescription
				drugs.
B. Wholesale distributors
				cannot operate from a place of residence.
C. Where wholesale distribution operations
				are conducted at more than one location, each such location shall be licensed
				by the board of pharmacy.
D. A
				wholesale distributor located in New Mexico shall be located apart and separate
				from any pharmacy.
E. Common or
				contract carriers or warehousemen, or an employee thereof, whose involvement in
				the wholesale distribution of prescription drugs occurs in the usual course of
				his business or employment shall not be required to obtain a wholesale drug
				distributor license from the board.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 8 - WHOLESALE PRESCRIPTION DRUG DISTRIBUTION › Section 16.19.8.10 - MINIMUM QUALIFICATIONS

Current through Register Vol. 35, No. 13, July 16, 2024
A. The
				board shall prohibit a person from receiving or maintaining licensure for
				wholesale distribution if the person:
(1) has
				been convicted of any felony for conduct relating to wholesale distribution,
				any felony violation of Subsection (i) or (k) of Section 301, or any felony
				violation of Section 1365 of title 18, United States Code, relating to product
				tampering; or
(2) has engaged in a
				pattern of violating the requirements of this section, or state requirements
				for licensure, that presents a threat of serious adverse health consequences or
				death to humans.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 8 - WHOLESALE PRESCRIPTION DRUG DISTRIBUTION › Section 16.19.8.11 - PERSONNEL

Current through Register Vol. 35, No. 13, July 16, 2024
As a condition of receiving and retaining a wholesale drug distributor license, the licensee shall require each person employed in any prescription drug wholesale distribution activity to have education, training, and experience, or any combination thereof, sufficient for that person to perform the assigned functions in such a manner as to provide assurance that the drug product quality, safety and security will at all times be maintained by law. Each person that is issued an initial or renewal license as a wholesale distributor whether in state or out of state must designate in writing on a form required by the board a person for each facility to serve as the designated representatives of the wholesale distributor.
A. To be certified as a designated representative a person must:
(1) submit an application on a form furnished by the board and provide information that includes:
(a) evidence of criminal background check and fingerprinting, the background check shall be sufficient to include all states residence since the person has been an adult;
(b) date of birth and social security number;
(c) occupations, positions of employment and offices held during the past seven years;
(d) whether the person during the past seven years has been enjoined, either temporarily or permanently, by a court of competent jurisdiction from violating and state or federal laws regulating the possession, control or wholesale distribution of prescription drugs or devices, together with details of such events;
(e) whether the person has been during the past seven years, the subject of any proceeding for the revocation of any professional or business license or any criminal violation and if so, the nature of the proceeding and the disposition of the proceeding;
(f) description of any involvement by the person with any business, including any investments, other than the ownership of stock in a publicly traded company or mutual fund during the past seven years, which manufactured, administered, prescribed, wholesale distributed or stored prescription drugs and devices in which such businesses were names as a party in a lawsuit;
(g) description of any criminal offense (not including minor traffic violations) of which the person, as an adult, was found guilty, regardless of whether adjudication of guilt was withheld or whether the person pled guilty or nolo contendere; if the person indicates that a criminal conviction is under appeal and submits a copy of the notice of appeal of the criminal offense, the applicant must, within 15 days after the disposition of the appeal, submit to the board a copy of the final written order of disposition; and
(h) any other information the board deems relevant;
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 8 - WHOLESALE PRESCRIPTION DRUG DISTRIBUTION › Section 16.19.8.12 - VIOLATIONS AND PENALTIES

Current through Register Vol. 35, No. 13, July 16, 2024
The board shall have the authority to suspend or revoke any
				  licenses granted under this part on the grounds established by law or
				  regulations; and may impose fines or civil penalties if allowed by law.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 8 - WHOLESALE PRESCRIPTION DRUG DISTRIBUTION › Section 16.19.8.13 - MINIMUM REQUIREMENTS FOR THE STORAGE AND HANDLING OF PRESCRIPTION DRUGS AND FOR THE ESTABLISHMENT AND MAINTENANCE OF PRESCRIPTION DRUG DISTRIBUTION RECORDS BY WHOLESALE DRUG DISTRIBUTORS AND THEIR OFFICERS, AGENTS, REPRESENTATIVES, AND EMPLOYEES

Current through Register Vol. 35, No. 13, July 16, 2024
A.
Facilities.
All facilities at which prescription drugs are stored,
				warehoused, handled, held, offered, marketed, or displayed 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 prescription drugs that are outdated, damaged,
				deteriorated, misbranded, counterfeit or suspected of being counterfeit or
				adulterated, suspect or illegitimate, otherwise unfit for distribution or
				wholesale distribution or that are in immediate or sealed, secondary containers
				that have been opened;
(4) be
				maintained in a clean and orderly condition; and
(5) be free from infestation by insects,
				rodents, birds, or vermin of any kind; and
(6) be a commercial location and not a
				personal dwelling or residence; and
(7) provide for the secure and confidential
				storage of information with restricted access and policies and procedures to
				protect the integrity and confidentiality of the information; and
(8) provide and maintain appropriate
				inventory controls in order to detect and document any theft, counterfeiting or
				diversion of prescription drugs or devices; and
(9) controlled substances must be isolated
				from non-controlled substance drugs and stored in a secure area in accordance
				with DEA security requirements and standards.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 8 - WHOLESALE PRESCRIPTION DRUG DISTRIBUTION › Section 16.19.8.14 - THIRD-PARTY LOGISTICS PROVIDER LICENSING REQUIREMENTS

Current through Register Vol. 35, No. 13, July 16, 2024
A. Every third-party logistics provider,
				wherever located, who engages in providing third-party logistics into, out of,
				or within this state must be licensed by the board in accordance with the laws
				and regulations of this state before engaging as a third-party logistics
				provider of prescription drugs.
B.
				Third-party logistics providers cannot operate from a place of
				residence.
C. Where third-party
				logistics operations are conducted at more than one location, each such
				location shall be licensed by the board.
D. A third-party logistics provider located
				in New Mexico shall be located apart and separate from any pharmacy.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 8 - WHOLESALE PRESCRIPTION DRUG DISTRIBUTION › Section 16.19.8.16 - MINIMUM QUALIFICATIONS

Current through Register Vol. 35, No. 13, July 16, 2024
A. The
				board will not license a third-party logistics provider when the FDA has made a
				finding that the third-party logistics provider does not utilize good handling
				and distribution practices and published notice thereof.
B. The board shall consider, at a minimum,
				the following factors in reviewing the qualifications of persons who engage in
				providing third-party logistics 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
				manufacture or distribution of prescription drugs, including controlled
				substances;
(4) the furnishing by
				the applicant of false or fraudulent material in any application;
(5) suspension, revocation or any other
				sanction 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 regulatory and 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 part; and
(8) any findings by the board that the
				applicant has violated or been disciplined, or the subject of administrative
				action, by a regulatory or licensing agency in any state for violating and
				federal, state, or local laws relating to drug or device
				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 8 - WHOLESALE PRESCRIPTION DRUG DISTRIBUTION › Section 16.19.8.17 - PERSONNEL

Current through Register Vol. 35, No. 13, July 16, 2024
As a condition of receiving and retaining a third-party logistics provider license, the licensee shall require each person employed in any prescription drug third-party logistics activity to have education, training, and experience, or any combination thereof, sufficient for that person to perform the assigned functions in such a manner as to provide assurance that the drug product quality, safety and security will at all times be maintained by law. Each person that is issued an initial or renewal license as a third-party-logistics provider whether in state or out of state must designate in writing on a form required by the board a person for each facility to serve as the designated representatives of the third-party logistics provider.
A. To be certified as a designated representative a person must:
(1) submit an application on a form furnished by the board and provide information that includes:
(a) evidence of criminal background check and fingerprinting, the background check shall be sufficient to include all states residence since the person has been an adult;
(b) date of birth and social security number;
(c) occupations, positions of employment and offices held during the past seven years;
(d) whether the person during the past seven years has been enjoined, either temporarily or permanently, by a court of competent jurisdiction from violating and state or federal laws regulating the possession, control or wholesale distribution of prescription drugs or devices, together with details of such events;
(e) whether the person has been during the past seven years, the subject of any proceeding for the revocation of any professional or business license or any criminal violation and if so, the nature of the proceeding and the disposition of the proceeding;
(f) description of any involvement by the person with any business, including any investments, other than the ownership of stock in a publicly traded company or mutual fund during the past seven years, which manufactured, administered, prescribed, distributed or stored prescription drugs and devices in which such businesses were names as a party in a lawsuit;
(g) description of any criminal offense (not including minor traffic violations) of which the person, as an adult, was found guilty, regardless of whether adjudication of guilt was withheld or whether the person pled guilty or nolo contendere; if the person indicates that a criminal conviction is under appeal and submits a copy of the notice of appeal of the criminal offense, the applicant must, within 15 days after the disposition of the appeal, submit to the board a copy of the final written order of disposition;
(h) any other information the board deems relevant;
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 8 - WHOLESALE PRESCRIPTION DRUG DISTRIBUTION › Section 16.19.8.18 - MINIMUM STANDARDS FOR THIRD-PARTY LOGISTICS PROVIDERS

Current through Register Vol. 35, No. 13, July 16, 2024
A.
Reporting
: Each facility of a
				third-party logistics provider shall comply with the FDA annual reporting
				requirements.
B.
Storage
				practices, facilities
: All third-party logistics provider facilities at
				which prescription drugs are stored, warehoused, handled, held, or displayed
				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
				prescription drugs that are outdated, damaged, deteriorated, misbranded,
				counterfeit or suspected of being counterfeit or adulterated, suspect or
				illegitimate, otherwise unfit for distribution or that are in immediate or
				sealed, secondary containers that have been opened;
(4) be maintained in a clean and orderly
				condition; and
(5) be free from
				infestation by insects, rodents, birds, or vermin of any kind; and
(6) be a commercial location and not a
				personal dwelling or residence; and
(7) provide for the secure and confidential
				storage of information with restricted access and policies and procedures to
				protect the integrity and confidentiality of the information; and
(8) provide and maintain appropriate
				inventory controls in order to detect and document any theft, counterfeiting or
				diversion of prescription drugs or devices; and
(9) controlled substances must be isolated
				from non-controlled substance drugs and stored in a secure area in accordance
				with DEA security requirements and standards.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 8 - WHOLESALE PRESCRIPTION DRUG DISTRIBUTION › Section 16.19.8.19 - REPACKAGER LICENSING REQUIREMENTS

Current through Register Vol. 35, No. 13, July 16, 2024
A. Every repackager, wherever located, who
				engages in distribution into, out of, or within this state must be licensed by
				the board in accordance with the laws and regulations of this state before
				engaging in repackaging or distribution of prescription drugs.
B. A repackager shall have valid registration
				with the FDA as a drug establishment under section 510 of the Federal
				Act.
C. Repackagers cannot operate
				from a place of residence.
D. Where
				repackaging operations are conducted at more than one location, each such
				location shall be licensed by the board.
E. The repackaging facility shall be located
				apart and separate from any pharmacy licensed by the board.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 8 - WHOLESALE PRESCRIPTION DRUG DISTRIBUTION › Section 16.19.8.21 - MINIMUM QUALIFICATIONS

Current through Register Vol. 35, No. 13, July 16, 2024
A. The board shall prohibit a person from receiving or maintaining repackager licensure if the person:
(1) has been convicted of any felony for conduct relating to manufacturing or distribution, any felony violation of Subsection (i) or (k) of section 301, or any felony violation of Section 1365 of title 18, United States Code, relating to product tampering; or
(2) has engaged in a pattern of violating the requirements of this section, or state requirements for licensure, that presents a threat of serious adverse health consequences or death to humans.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 8 - WHOLESALE PRESCRIPTION DRUG DISTRIBUTION › Section 16.19.8.22 - PERSONNEL

Current through Register Vol. 35, No. 13, July 16, 2024
As a condition of receiving and retaining a repackager license, the licensee shall require each person employed in any repackaging or distribution activity to have education, training, and experience, or any combination thereof, sufficient for that person to perform the assigned functions in such a manner as to provide assurance that the drug product quality, safety and security will at all times be maintained by law. Each person that is issued an initial or renewal license as a repackager whether in state or out of state must designate in writing on a form required by the board a person for each facility to serve as the designated representatives of the repackager.
A. Each licensed repackager located outside of this state that distributes prescription drugs in this state shall designate a registered agent in this state for service of process. Any licensed repackager that does not so designate a registered agent shall be deemed to have designated the secretary of state of this state to be its true and lawful attorney, upon who may be served all legal processes in any action or proceeding against such licensed repackager growing out of or arising from such manufacture or distribution. A copy of any such service or process shall be mailed to such repackager by the board by certified mail, return receipt requested, postage prepaid, at the address such licensed repackager has designated on its application for licensure in this state. If any such repackager is not licensed in this state, service on the secretary of state only shall be sufficient service.
B. A designated representative must complete training programs that address applicable state and federal laws and are provided by qualified in-house specialists, outside counsel or counseling specialists with capabilities to help ensure compliance.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 8 - WHOLESALE PRESCRIPTION DRUG DISTRIBUTION › Section 16.19.8.23 - REPACKAGER MINIMUM STANDARDS

Current through Register Vol. 35, No. 13, July 16, 2024
A.
Compliance with federal, state, and local law.
A repackager shall
				operate in compliance with applicable federal, state, and local laws and
				regulations.
(1) A repackager shall comply
				with 16.19.9 NMAC, including operation in compliance with the Federal Food,
				Drug, and Cosmetic Act;
Good Manufacturing Practices
,
				21 U.S.C.
				321,
				351,
				352,
				355,
				360b,
				371,
				374; 42 U.S.C. 216,
				262, 263a, 264; and 21 C.F.R. Parts 210 and 211.
(2) A repackager shall permit board
				authorized personnel and authorized federal, state and local law enforcement
				officials, to enter and inspect its premises and delivery vehicles, and to
				audit its records and written operating procedures, at reasonable times and in
				a reasonable manner, to the extent authorized by law, and to confiscate
				prescription drugs and records to the extent authorized by law or rules. Such
				officials shall be required to show appropriate identification prior to being
				permitted access to wholesale drug distributors' premises and delivery
				vehicles.
(3) Inventories, records
				and written operating procedures shall be made available for inspection and
				photocopying by authorized inspectors employed by the board for a period of
				three years following disposition of the drugs.
(4) Repackagers that deal in controlled
				substances shall register with the board and with the DEA, and shall comply
				with all applicable state, local and DEA regulations.
(5) A repackager may distribute only to
				authorized trading partners. Product shall be delivered only to the licensed
				address of the authorized trading partner.
(6) 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.
(7) Product tracing, product identifier, and
				verification: Repackagers licensed by the board shall comply with the
				requirements for tracing products through the distribution system as defined in
				Sections 353 and 360eee, et seq., of the DSCSA,
				21
				U.S.C. 301, et seq., and successor FDA
				regulations, with respect to the role of such repackager including any
				requirements with respect to: transaction history, transaction information, or
				transaction statement of a product as such product changes ownership in the
				supply chain, or verification, investigation, disposition, notification, or
				recordkeeping relating to such systems, including paper or electronic pedigree
				systems or for tracking and tracing drugs throughout the distribution
				system.
(8) Authorized trading
				partners: The trading partners of a repackager may be only authorized trading
				partners.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 8 - WHOLESALE PRESCRIPTION DRUG DISTRIBUTION › Section 16.19.8.24 - MANUFACTURER REQUIREMENTS

Current through Register Vol. 35, No. 13, July 16, 2024
A.
Product tracing, product identifier, and verification:
Manufacturers shall comply with the requirements for tracing products through
				the distribution system as defined in Sections 353 and 360eee, et seq., of the
				DSCSA,
				21
				U.S.C. 301, et seq., and successor FDA
				regulations, with respect to the role of such manufacturer including any
				requirements with respect to: transaction history, transaction information, or
				transaction statement of a product as such product changes ownership in the
				supply chain, or verification, investigation, disposition, notification, or
				recordkeeping relating to such systems, including paper or electronic pedigree
				systems or for tracking and tracing drugs throughout the distribution
				system.
B.
Authorized trading
				partners
: The trading partners of a manufacturer may be only authorized
				trading partners.
C.
Compliance with federal, state, and local law:
Manufacturers shall
				operate in compliance with applicable federal, state, and local laws and
				regulations. Manufacturers that deal in controlled substances shall register
				with the board and with the DEA, and shall comply with all applicable state,
				local and DEA regulations.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 9 - MINIMUM STANDARDS FOR MANUFACTURERS AND REPACKAGING FIRMS › Section 16.19.9.1 - 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 9 - MINIMUM STANDARDS FOR MANUFACTURERS AND REPACKAGING FIRMS › Section 16.19.9.2 - SCOPE

Current through Register Vol. 35, No. 13, July 16, 2024
All manufacturers, packagers and distributors, other than
				  wholesalers, of drugs, including radioactive pharmaceuticals.