NMSA 1978, § 26-1-1 Short title
26-1-1. Short title
Chapter 26, Article 1 NMSA 1978 may be cited as the "New Mexico Drug, Device and Cosmetic Act".
1953 Comp., § 54-6-26, enacted by Laws 1967, ch. 23, § 1; 1987, ch. 270, § 1.
General Provisions
NMSA 1978 ch. 26, art. 1
in effectNMSA 1978, § 26-1-2 Definitions
26-1-2. Definitions
As used in the New Mexico Drug, Device and Cosmetic Act:
A. "board" means the board of pharmacy or its duly authorized agent;
B. "person" includes an individual, partnership, corporation, association, institution or establishment;
C. "biological product" means any of the following that is applicable to the prevention, treatment or cure of a disease or condition of human beings:
(1) a virus;
(2) a therapeutic serum;
(3) a toxin;
(4) an antitoxin;
(5) a vaccine;
(6) blood;
(7) a blood component or derivative;
(8) an allergenic product;
(9) a protein, except any chemically synthesized polypeptide;
(10) a product that is analogous to any of the products listed in Paragraphs (1) through (9) of this subsection; or
(11) arsphenamine, a derivative of arsphenamine or any other trivalent organic arsenic compound;
D. "biosimilar" or "biosimilarity" means, in reference to a biological product that the federal food and drug administration has licensed, that:
(1) the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components; and
(2) there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity and potency of the product;
E. "controlled substance" means a drug, substance or immediate precursor enumerated in Schedules I through V of the Controlled Substances Act [Chapter 30, Article 31 NMSA 1978];
F. "drug" means articles:
(1) recognized in an official compendium;
(2) intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in humans or other animals and includes the domestic animal biological products regulated under the federal Animal Virus, Serum, Toxin, Antitoxin Act, 37 Stat 832-833, 21 U.S.C. 151-158, and the biological products applicable to humans regulated under Federal 58 Stat 690, as amended, 42 U.S.C. 216, Section 351, 58 Stat 702, as amended, and 42 U.S.C. 262;
(3) other than food, that affect the structure or any function of the human body or the bodies of other animals; and
(4) intended for use as a component of Paragraph (1), (2) or (3) of this subsection, but "drug" does not include devices or their component parts or accessories;
G. "dangerous drug" means a drug, other than a controlled substance enumerated in Schedule I of the Controlled Substances Act, that because of a potentiality for harmful effect or the method of its use or the collateral measures necessary to its use is not safe except under the supervision of a practitioner licensed by law to direct the use of such drug and hence for which adequate directions for use cannot be prepared. "Adequate directions for use" means directions under which the layperson can use a drug or device safely and for the purposes for which it is intended. A drug shall be dispensed only upon the prescription or drug order of a practitioner licensed by law to administer or prescribe the drug if it:
(1) is a habit-forming drug and contains any quantity of a narcotic or hypnotic substance or a chemical derivative of such substance that has been found under the federal act and the board to be habit forming;
(2) because of its toxicity or other potential for harmful effect or the method of its use or the collateral measures necessary to its use is not safe for use except under the supervision of a practitioner licensed by law to administer or prescribe the drug;
(3) is limited by an approved application by Section 505 of the federal act to the use under the professional supervision of a practitioner licensed by law to administer or prescribe the drug;
(4) bears the legend: "Caution: federal law prohibits dispensing without prescription.";
(5) bears the legend: "Caution: federal law restricts this drug to use by or on the order of a licensed veterinarian."; or
(6) bears the legend "Rx only";
H. "counterfeit drug" means a drug that is deliberately and fraudulently mislabeled with respect to its identity, ingredients or sources. Types of such pharmaceutical counterfeits may include:
(1) "identical copies", which are counterfeits made with the same ingredients, formulas and packaging as the originals but not made by the original manufacturer;
(2) "look-alikes", which are products that feature high-quality packaging and convincing appearances but contain little or no active ingredients and may contain harmful substances;
(3) "rejects", which are drugs that have been rejected by the manufacturer for not meeting quality standards; and
(4) "relabels", which are drugs that have passed their expiration dates or have been distributed by unauthorized foreign sources and may include placebos created for late-phase clinical trials;
I. "device", except when used in Subsection R of this section and in Subsection G of Section 26-1-3, Subsection L and Paragraph (4) of Subsection A of Section 26-1-11 and Subsection C of Section 26-1-24 NMSA 1978, means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or other similar or related article, including any component, part or accessory, that is:
(1) recognized in an official compendium;
(2) intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease in humans or other animals; or
(3) intended to affect the structure or a function of the human body or the bodies of other animals and that does not achieve any of its principal intended purposes through chemical action within or on the human body or the bodies of other animals and that is not dependent on being metabolized for achievement of any of its principal intended purposes;
J. "prescription" means an order given individually for the person for whom prescribed, either directly from a licensed practitioner or the practitioner's agent to the pharmacist, including by means of electronic transmission, or indirectly by means of a written order signed by the prescriber, and bearing the name and address of the prescriber, the prescriber's license classification, the name and address of the patient, the name and quantity of the drug prescribed, directions for use and the date of issue;
K. "practitioner" means a certified advanced practice chiropractic physician, physician, doctor of oriental medicine, dentist, veterinarian, euthanasia technician, certified nurse practitioner, clinical nurse specialist, pharmacist, pharmacist clinician, certified nurse-midwife, physician assistant, prescribing psychologist, dental hygienist, optometrist, naturopathic doctor or other person licensed or certified to prescribe and administer drugs that are subject to the New Mexico Drug, Device and Cosmetic Act. "Practitioner" also means a registered lay midwife licensed by the department of health who is certified or licensed in accordance with department of health rules to procure, carry and administer drugs that are subject to the New Mexico Drug, Device and Cosmetic Act;
L. "cosmetic" means:
(1) articles intended to be rubbed, poured, sprinkled or sprayed on, introduced into or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness or altering the appearance; and
(2) articles intended for use as a component of any articles enumerated in Paragraph (1) of this subsection, except that the term shall not include soap;
M. "interchangeable biological product" means a biological product that the federal food and drug administration has licensed and:
(1) has determined that the biological product is biosimilar to the reference product and can be expected to produce the same clinical result as the reference product in any given patient;
(2) for a biological product that is administered more than once to an individual and:
(a) has determined to have been administered more than once to the individual; or
(b) for which the risk in terms of safety or diminished efficacy of alternating or switching between use of the biological product and the reference product is not greater than the risk of using the reference product without alternation or switching; or
(3) has determined to be therapeutically equivalent as set forth in the latest edition or supplement to the federal food and drug administration's approved drug products with therapeutic equivalence evaluations;
N. "official compendium" means the official United States pharmacopeia and national formulary or the official homeopathic pharmacopoeia of the United States or any supplement to either of them;
O. "label" means a display of written, printed or graphic matter upon the immediate container of an article. A requirement made by or under the authority of the New Mexico Drug, Device and Cosmetic Act that any word, statement or other information appear on the label shall not be considered to be complied with unless the word, statement or other information also appears on the outside container or wrapper, if any, of the retail package of the article or is easily legible through the outside container or wrapper;
P. "immediate container" does not include package liners;
Q. "labeling" means all labels and other written, printed or graphic matter:
(1) on an article or its containers or wrappers; or
(2) accompanying an article;
R. "misbranded" means a label to an article that is misleading. In determining whether the label is misleading, there shall be taken into account, among other things, not only representations made or suggested by statement, word, design, device or any combination of the foregoing, but also the extent to which the label fails to reveal facts material in the light of such representations or material with respect to consequences that may result from the use of the article to which the label relates under the conditions of use prescribed in the label or under such conditions of use as are customary or usual;
S. "advertisement" means all representations disseminated in any manner or by any means, other than by labeling, for the purpose of inducing, or that are likely to induce, directly or indirectly, the purchase of drugs, devices or cosmetics;
T. "antiseptic", when used in the labeling or advertisement of an antiseptic, shall be considered to be a representation that it is a germicide, except in the case of a drug purporting to be or represented as an antiseptic for inhibitory use as a wet dressing, ointment, dusting powder or such other use as involves prolonged contact with the body;
U. "new drug" means a drug:
(1) the composition of which is such that the drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and efficacy of drugs, as safe and effective for use under the conditions prescribed, recommended or suggested in the labeling thereof; or
(2) the composition of which is such that the drug, as a result of investigation to determine its safety and efficacy for use under such conditions, has become so recognized, but that has not, otherwise than in such investigations, been used to a material extent or for a material time under such conditions;
V. "contaminated with filth" applies to a drug, device or cosmetic not securely protected from dirt, dust and, as far as may be necessary by all reasonable means, from all foreign or injurious contaminations, or a drug, device or cosmetic found to contain dirt, dust, foreign or injurious contamination or infestation;
W. "selling of drugs, devices or cosmetics" shall be considered to include the manufacture, production, processing, packing, exposure, offer, possession and holding of any such article for sale and the sale and the supplying or applying of any such article in the conduct of a drug or cosmetic establishment;
X. "color additive" means a material that:
(1) is a dye, pigment or other substance made by a process of synthesis or similar artifice or extracted, isolated or otherwise derived, with or without intermediate or final change of identity, from a vegetable, mineral, animal or other source; or
(2) when added or applied to a drug or cosmetic or to the human body or a part thereof, is capable, alone or through reaction with other substances, of imparting color thereto; except that such term does not include any material that has been or hereafter is exempted under the federal act;
Y. "federal act" means the Federal Food, Drug, and Cosmetic Act;
Z. "restricted device" means a device for which the sale, distribution or use is lawful only upon the written or oral authorization of a practitioner licensed by law to administer, prescribe or use the device and for which the federal food and drug administration requires special training or skills of the practitioner to use or prescribe. This definition does not include custom devices defined in the federal act and exempt from performance standards or premarket approval requirements under Section 520(b) of the federal act;
AA. "prescription device" means a device that, because of its potential for harm, the method of its use or the collateral measures necessary to its use, is not safe except under the supervision of a practitioner licensed in this state to direct the use of such device and for which "adequate directions for use" cannot be prepared, but that bears the label: "Caution: federal law restricts this device to sale by or on the order of a __________", the blank to be filled with the word "physician", "physician assistant", "certified advanced practice chiropractic physician", "doctor of oriental medicine", "dentist", "veterinarian", "euthanasia technician", "certified nurse practitioner", "clinical nurse specialist", "pharmacist", "pharmacist clinician", "certified nurse-midwife", "dental hygienist", registered lay midwife, "optometrist" or "naturopathic doctor" or with the descriptive designation of any other practitioner licensed in this state to use or order the use of the device;
BB. "valid practitioner-patient relationship" means a professional relationship, as defined by the practitioner's licensing board, between the practitioner and the patient;
CC. "pedigree" means the recorded history of a drug;
DD. "drug order" means an order either directly from a licensed practitioner or the practitioner's agent to the pharmacist, including by means of electronic transmission or indirectly by means of a written order signed by the licensed practitioner or the practitioner's agent, and bearing the name and address of the practitioner and the practitioner's license classification and the name and quantity of the drug or device ordered for use at an inpatient or outpatient facility; and
EE. "reference product" means the single biological product against which a biosimilar was evaluated in its marketing application to the federal food and drug administration.
1953 Comp., § 54-6-27, enacted by Laws 1967, ch. 23, § 2; 1971, ch. 245, § 2; 1972, ch. 84, § 43; 1977, ch. 117, § 1; 1987, ch. 270, § 2; 1997, ch. 240, § 1; 1997, ch. 244, § 1; 1997, ch. 253, § 2; 1999, ch. 298, § 1; 2001, ch. 50, § 1; 2002, ch. 100, § 1; 2005, ch. 152, § 1; 2008, ch. 9, § 3; 2008, ch. 44, § 4; 2009, ch. 102, § 1; 2011, ch. 113, § 1; 2013, ch. 157, § 1; 2015, ch. 131, § 6; 2017, ch. 48, § 1; 2019, ch. 11, § 1; 2019, ch. 244, § 14.
NMSA 1978, § 26-1-3 Prohibited acts
26-1-3. Prohibited acts
The following acts are prohibited:
A. the sale of any drug or device that is adulterated, misbranded or a counterfeit drug which is not a controlled substance;
B. the adulteration or misbranding of any drug or device;
C. the receipt or delivery in commerce of any drug or device that is adulterated, misbranded or a counterfeit drug which is not a controlled substance;
D. the dissemination of any false advertisement;
E. the giving of a false guaranty or undertaking, except by a person who relied on a guaranty or undertaking as attested by label or labeling from whom he received in good faith the drug or device for sale;
F. any act with respect to a drug or device when the act is done while the drug or device is held for sale and results in the drug or device being misbranded or adulterated;
G. the creation, sale, disposition, possession or concealment of any punch, die, plate, stone or other thing designed to print, imprint or reproduce the trademark, trade name or other identifying mark, imprint, device of another or any likeness of any of the foregoing upon any drug or container or labeling so as to render the drug a counterfeit drug;
H. concealment, disposition or possession with intent to sell or preparation with intent to defraud of a counterfeit drug;
I. in the case of a dangerous drug distributed or offered for sale in this state, the failure of the manufacturer or repackager to transmit, to any practitioner licensed to administer the drug who makes a written request for information, true and correct copies of all printed matter which is required to be included in any package in which that drug is distributed or sold or such other printed matter as is approved under the federal act. Nothing in this subsection shall be construed to exempt any person from any labeling requirement imposed under other provisions of the New Mexico Drug, Device and Cosmetic Act [26-1-1 NMSA 1978] and the Controlled Substances Act [Chapter 30, Article 31 NMSA 1978]; and
J. except as provided in Sections 26-3-1 through 26-3-3 NMSA 1978, dispensing or causing to be dispensed a different drug or brand of drug in place of the drug or brand of drug ordered or prescribed without the express permission in each case of the person ordering or prescribing.
1953 Comp., § 54-6-28, enacted by Laws 1967, ch. 23, § 3; 1972, ch. 84, § 44; 1976, ch. 60, § 1; 1987, ch. 270, § 3.
NMSA 1978, § 26-1-3.2 Prescription drug donation
26-1-3.2. Prescription drug donation
A. As used in this section:
(1) "donor" means a person who donates unused prescription drugs to an eligible recipient for the purpose of redistribution to patients;
(2) "eligible recipient" means a person who registers with the board to participate in the collection of donated drugs and is:
(a) licensed pursuant to Section 61-11-14 NMSA 1978 to receive and distribute prescription drugs;
(b) a health care facility licensed by the health care authority pursuant to the Health Care Code [Chapter 24A NMSA 1978]; or
(c) a practitioner licensed to prescribe prescription drugs;
(3) "patient" means an individual who voluntarily receives donated prescription drugs; and
(4) "tamper-evident" means a device or process that makes unauthorized access to protected pharmaceutical packaging easily detected.
B. The board shall adopt and promulgate rules for the donation of unused prescription drugs. Any person, including persons from other states, may donate unexpired and unused prescription drugs to an eligible recipient, and an eligible recipient may accept and redistribute the donated prescription drugs in accordance with rules promulgated by the board. Donated prescription drugs shall only be redistributed to a patient if the drugs will not expire before the patient is able to completely use the drugs, based on the directions for use given by the patient's prescribing health care professional.
C. The board shall promulgate rules to establish:
(1) procedures to allow the donation and redistribution of certain prescription drugs, including refrigerated drugs, that:
(a) ensure that the redistribution process is consistent with public health and safety standards;
(b) exclude controlled substances; and
(c) allow in-state and out-of-state pharmacies that are experienced in managing donated prescription drugs to distribute donated prescription drugs to patients, either at a physical pharmacy location or through a mail-order pharmacy;
(2) standards and procedures for accepting, storing, labeling and redistributing donated prescription drugs;
(3) standards and procedures for inspecting donated prescription drugs to determine that the packaging is tamper-evident and that the donated prescription drugs are unadulterated, safe and suitable for redistribution;
(4) a form to be signed by the patient specifying:
(a) knowledge that the donor took reasonable care of the donated prescription drug;
(b) knowledge that the donated prescription drugs have been inspected prior to being dispensed and that there is no reason to believe that the donated prescription drug was improperly handled or stored;
(c) that any person who exercises reasonable care in donating, accepting or redistributing pursuant to this section shall be immune from civil or criminal liability or professional disciplinary action of any kind for any related injury, death or loss; and
(d) that the immunity provided by this section shall not decrease or increase the civil or criminal liability of a drug manufacturer, distributor or dispenser that would have existed but for the donation;
(5) information required to be provided by the donor verifying that:
(a) the donated prescription drug has been properly stored and the container has not been opened or tampered with;
(b) the donated prescription drug has not been adulterated or misbranded; and
(c) the donor is voluntarily donating the prescription drug;
(6) a handling fee not to exceed the reasonable costs of participating in the collection of donated prescription drugs that may be charged to the patient by the eligible recipient to cover the costs of inspecting, storing, labeling and redistributing the donated prescription drug; and
(7) any other standards deemed necessary by the board.
D. The board shall maintain and publish a current listing of eligible recipients.
E. Before redistributing donated prescription drugs, the eligible recipient shall:
(1) comply with all applicable federal laws and the laws of the state that deal with the inspection, storage, labeling and redistribution of donated prescription drugs; and
(2) examine the donated prescription drug to determine that it has not been adulterated or misbranded and certify that the drug has been stored in compliance with the requirements of the product label.
F. Any person who exercises reasonable care in donating, accepting or redistributing prescription drugs pursuant to this section shall be immune from civil or criminal liability or professional disciplinary action of any kind for any related injury, death or loss.
G. The immunity provided by this section shall not decrease or increase the civil or criminal liability of a drug manufacturer, distributor or dispenser that would have existed but for the donation.
H. A manufacturer shall not be liable for failure to transfer or communicate product consumer information or the expiration date of the donated prescription drug pursuant to this section.
I. This section does not restrict the authority of an appropriate governmental agency to regulate or ban the use of any prescription drugs.
Laws 2011, ch. 119, § 1; 2025, ch. 116, § 1.
NMSA 1978, § 26-1-4 Power to enjoin violations
26-1-4. Power to enjoin violations
In addition to the remedies provided the board is authorized to apply to the district court for, and the court shall have jurisdication [jurisdiction] upon hearing and for cause shown, to grant a temporary or permanent injunction restraining any other person from violating any provision of Section 3 [26-1-3 NMSA 1978] of the New Mexico Drug and Cosmetic Act [New Mexico Drug Device and Cosmetic Act], irrespective of whether or not there exists an adequate remedy at law.
1953 Comp., § 54-6-29, enacted by Laws 1967, ch. 23, § 4.
NMSA 1978, § 26-1-5 Penalty; exemptions
26-1-5. Penalty; exemptions
No publisher, radio-broadcast licensee, or agency or medium for the dissemination of an advertisement, except the manufacturer, packer, distributor or seller of the article to which a false advertisement relates, shall be liable under this section [act] by reason of dissemination by him of such false advertisement, unless he has refused, on the request of the board, to furnish the board the name and post-office address of the manufacturer, packer, distributor, seller or advertising agency, who cause [caused] him to disseminate such advertisement.
1953 Comp., § 54-6-30, enacted by Laws 1967, ch. 23, § 5.
NMSA 1978, § 26-1-6 Detection of drugs, devices or cosmetic believed adulterated, misbranded or counterfeit; condemnation; destruction or correction of defect; forfeiture and sale
26-1-6. Detection of drugs, devices or cosmetic believed adulterated, misbranded or counterfeit; condemnation; destruction or correction of defect; forfeiture and sale
A. Whenever an authorized agent of the board has probable cause to believe that any drug, device or cosmetic is adulterated, misbranded or counterfeit, he shall affix to such article appropriate marking, giving notice that the article is suspected of being adulterated, misbranded or counterfeit and has been detained or embargoed, and warning all persons not to remove or dispose of such article until permission for removal or disposal is given by the agent or the court. It is unlawful for any person to remove or dispose of such detained or embargoed article without such permission.
B. When an article detained or embargoed has been found by the agent to be adulterated, misbranded or counterfeit he shall petition the judge of the district court in whose jurisdiction the article is detained or embargoed for a libel for condemnation of such article. When the agent has found that an article so detained or embargoed is not adulterated, misbranded or counterfeit he shall remove the marking.
C. If the court finds that a detained or embargoed article is adulterated or misbranded or counterfeit, the article shall, after entry of the decree, be destroyed at the expense of the claimant under the supervision of the agent, and all court costs and fees, and storage and other proper expenses shall be taxed against the claimant of the article or his agent. However, when the adulteration or misbranding can be corrected by proper labeling or processing of the article, the court, after entry of the decree and after costs, fees and expenses have been paid and a sufficient bond has been executed, conditioned that the article shall be so labeled or processed, may by order direct that the article be delivered to the claimant for labeling or processing under the supervision of an agent of the board. The expense of the supervision shall be paid by the claimant. The bond shall be returned to the claimant of the article on representation to the court by the board that the article is no longer in violation of the New Mexico Drug and Cosmetic Act [New Mexico Drug Device and Cosmetic Act] and that the expenses of the supervision have been paid.
D. The following may be seized by a duly authorized law enforcement official of the state whenever he has reasonable grounds to believe they are:
(1) a drug other than a controlled substance, that is counterfeit;
(2) a container of a counterfeit drug;
(3) any punch, die, plate, stone, labeling, container or other thing used or designed for use in making a counterfeit drug or drugs.
E. When an article, equipment or other thing is seized under Section 6D [26-1-6D NMSA 1978] of the New Mexico Drug and Cosmetic Act [New Mexico Drug Device and Cosmetic Act], the proceedings shall be brought in the name of the state by the prosecuting attorney of the county in which the article was seized, and the libel shall be verified by a duly authorized agent of the state in a manner required by the law of this state. The libel shall describe the merchandise, state its location, state the name of the person in actual possession, state the name of the owner, if known to the duly authorized agent of the state, allege the essential elements of the violation which is claimed to exist and shall conclude with a prayer of due process to enforce the forfeiture. Upon the filing of libel the court shall properly cause process to issue to the authorized law enforcement official commanding him to seize the goods described in the libel and to hold the same for further order of the court. The authorized law enforcement official shall at the time of seizure serve a copy of said process upon the owner of said merchandise. Such service may be made personally, by mail or by publication according to the rules governing the service of civil process in this state. At the expiration of twenty days after such seizure, if no claimant has appeared to defend the libel, the court shall order the authorized law enforcement official to dispose of said merchandise.
F. Any person having an interest in the alleged article, equipment or other thing proceeded against, or any person against whom a civil or criminal liability would exist if said merchandise is in violation of Section 3 [26-1-3 NMSA 1978] of the New Mexico Drug and Cosmetic Act [New Mexico Drug Device and Cosmetic Act] may, within twenty days following the authorized law enforcement official's seizure, appear and file answer or demurrer to the libel. The answer or demurrer shall allege the interest or liability of the party filing it. In all other respects the issue shall be made up as in other civil actions.
G. Any article, equipment or other thing condemned under this section shall, after entry of the decree, be disposed of by destruction or sale as the court may, in accordance with the provisions of this section, direct and the proceeds, if sold, less the legal costs and charges, shall be paid to the general fund; but such article, equipment or other thing shall not be sold under such decree contrary to provisions of the New Mexico Drug and Cosmetic Act [New Mexico Drug Device and Cosmetic Act]. Whenever in any proceedings under this section the condemnation of any equipment or other thing, other than a drug, is decreed, the court shall allow the claim of any claimant, to the extent of such claimant's interest, for remission or mitigation of such forfeiture if such claimant proves to the satisfaction of the court that he has not committed or caused to be committed any prohibited act referred to in this section and has no interest in any drug referred to therein; that he has an interest in such equipment or other thing as owner or lienor or otherwise, acquired by him in good faith; and that he at no time had any knowledge or reason to believe that such equipment or other thing was being or would be used in, or to facilitate, the violation of the laws of this state relating to counterfeit drugs.
H. When a decree of condemnation is entered against the article, equipment or other thing, court costs and fees and storage and other proper expenses may be awarded against the person, if any, intervening as claimant of the article.
1953 Comp., § 54-6-31, enacted by Laws 1967, ch. 23, § 6; 1971, ch. 241, § 1; 1972, ch. 84, § 45.
NMSA 1978, § 26-1-7 Attorney general or district attorney to institute prosecutions
26-1-7. Attorney general or district attorney to institute prosecutions
It is the duty of the attorney general or the various district attorneys of this state to whom the board reports any violation of the New Mexico Drug, Device and Cosmetic Act to cause appropriate proceedings to be instituted in the proper courts without delay and to be prosecuted in the manner required by law.
1953 Comp., § 54-6-32, enacted by Laws 1967, ch. 23, § 7; 2005, ch. 152, § 2.
NMSA 1978, § 26-1-8 Minor violations of act; warnings authorized
26-1-8. Minor violations of act; warnings authorized
Nothing in the New Mexico Drug and Cosmetic Act [New Mexico Drug, Device and Cosmetic Act] shall be construed as requiring the board to report for the institution of proceedings, minor violations of the New Mexico Drug and Cosmetic Act [New Mexico Drug, Device and Cosmetic Act], whenever the board believes that the public interest will be adequately served in the circumstances by a suitable written notice or warning.
1953 Comp., § 54-6-33, enacted by Laws 1967, ch. 23, § 8.
NMSA 1978, § 26-1-9 Addition of poisonous or deleterious substances; color additives
26-1-9. Addition of poisonous or deleterious substances; color additives
A. The board may adopt regulations authorizing color additives.
B. Any added poisonous or deleterious substance or any color additive, shall with respect to any particular use or intended use be deemed unsafe for the purpose of application of Section 10A [26-1-10 NMSA 1978] of the New Mexico Drug and Cosmetic Act [New Mexico Drug, Device and Cosmetic Act] with respect to any drug or device or Section 25A [26-1-25 NMSA 1978] of the New Mexico Drug and Cosmetic Act [New Mexico Drug, Device and Cosmetic Act] with respect to any cosmetic unless there is in effect a regulation pursuant to Subsection C of this section limiting the quantity of such substance, and the use or intended use of such substance conform [conforms] to the terms prescribed by such regulation. While such regulation relating to such substance is in effect, drug or cosmetic shall not, by reason of bearing or containing such substance in accordance with the regulation be considered adulterated within the meaning of Section 10 or Section 25 of the New Mexico Drug and Cosmetic Act [New Mexico Drug, Device and Cosmetic Act].
C. The board, whenever public health or other considerations in the state so require, is authorized to adopt, amend or repeal regulations whether or not in accordance with regulations promulgated under the federal act, prescribing the conditions under which a color additive may be safely used and exemptions where such color additive is to be used solely for investigational or experimental purposes, upon its own motion or upon the petition of any interested party requesting that such a regulation be established, and it shall be incumbent upon the petitioner to establish by data submitted to the board of pharmacy that a necessity exists for such regulation, and that its effect will not be detrimental to public health. If the data furnished by the petitioner is not sufficient to allow the board to determine whether such regulation should be promulgated, the board may require additional data to be submitted and failure to comply with the request shall be sufficient grounds to deny the request. In adopting, amending or repealing regulations relating to such substances, the board shall consider among other relevant factors, the following which the petitioner, if any, shall furnish:
(1) the name and all pertinent information concerning such substance including where available, its chemical identity and composition, a statement of conditions of the proposed use, including directions, recommendations and suggestions and including specimens of proposed labeling, all relevant data bearing on the physical or other technical effect and the quantity required to produce such effect;
(2) the probable composition of, or the relevant exposure from the article and of any substance formed in or on a drug or cosmetic resulting from the use of such substance;
(3) safety factors which, in the opinion of experts qualified by scientific training and experience to evaluate the safety of such substances for the use or uses for which they are proposed to be used, are generally recognized as appropriate for the use of animal experimentation data;
(4) the availability of any needed practicable methods of analysis for determining the identity and quantity of:
(a) such substance in or on an article;
(b) any substance formed in or on such article because of the use of such substance; and
(c) the pure substance and all intermediates and impurities; and
(5) facts supporting a contention that the proposed use of such substance will serve a useful purpose.
1953 Comp., § 54-6-34, enacted by Laws 1967, ch. 23, § 9.
NMSA 1978, § 26-1-10 Drug or device adulteration
26-1-10. Drug or device adulteration
A drug or device shall be deemed to be adulterated:
A. if it consists in whole or in part of any filthy, putrid or decomposed substance; or if it has been produced, prepared, packed or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health; or if it 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 and Cosmetic Act [New Mexico Drug, Device and Cosmetic Act] as to safety and has the identity and strength, and meets the quality and purity characteristics which it purports or is represented to possess; or if it is a drug and its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or if it 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 purposes of coloring only, and is unsafe within the meaning of the federal act;
B. if it 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 tests 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 therefor set forth if such standard is plainly stated on its label. Whenever a drug is recognized both in the United State [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;
C. if it is not subject to the provisions of Subsection B of this section and its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess; or
D. if it 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 therefor.
1953 Comp., § 54-6-35, enacted by Laws 1967, ch. 23, § 10.
NMSA 1978, § 26-1-11 Drug or device; misbranding
26-1-11. Drug or device; misbranding
A. A drug or device shall be deemed to be misbranded:
(1) if its labeling is false or misleading in any particular;
(2) if in package form, unless it bears a label containing the name and place of the business of the manufacturer, packer or distributor and an accurate statement of the quantity of the contents in terms of weight, measure or numerical count; provided that reasonable variations shall be permitted and exemptions as to small packages shall be allowed in accordance with regulations prescribed by the board or issued under the federal act;
(3) if it is a drug subject to the restrictions on sale contained in Subparagraph 1 of Subsection (b) of 21 U.S.C. Section 353, which provisions describe those substances commonly referred to as "legend drugs", and if the drug is in package form, unless it bears a label on its immediate container, and on any outer container if such there be, including the name and place of the business of the manufacturer of the finished dosage form and the name and place of business of the packer or distributor and an accurate statement of the quantity of the contents in terms of weight, measure or numerical count;
(4) if any word, statement or other information required by or under authority of the New Mexico Drug, Device and Cosmetic Act to appear on the label or labeling is not prominently placed with such conspicuousness, as compared with other words, statements, designs or devices in the labeling, and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use;
(5) if it is for use by man and contains any quantity of a narcotic or hypnotic substance or any chemical derivative of such substance, which derivative after investigation has been found to be and designated as habit-forming by regulations issued pursuant to Section 502(d) or 511 of the federal act, unless its label bears the name and quantity or proportion of such substance or derivative and in juxtaposition therewith the statement "Warning - May be habit-forming" and meets labeling requirements of the federal Comprehensive Drug Abuse Prevention and Control Act of 1970; or
(6) if it is a drug, unless the label bears, to the exclusion of any other nonproprietary name except the applicable systematic chemical name or the chemical formula, the established name, as defined in this section, of the drug, and in case it is fabricated from two or more active ingredients, the established name and quantity of each active ingredient, including the kind and quantity or proportion of any alcohol and also including the established name and quantity or proportion of any bromides, ether, chloroform, acetanilid, acetphenetidin, antipyrine, amidropyrine, atropine, hyoscine, hyoscyamine, arsenic, digitalis, digitalis glycosides, mercury, ouabain, strophanthin, strychnine, thyroid or any derivative or preparation of any such substances contained therein; provided that the requirements for stating the quantity of the active ingredients, other than the quantity of those specifically named in this section, shall apply only to prescription drugs; provided, further, that to the extent that compliance with the requirements of this section is impracticable, exemptions shall be allowed under regulations promulgated by the board or under the federal act.
B. As used in this section, the term "established name" with respect to a drug or ingredient means:
(1) the applicable official name designated pursuant to Section 508 of the federal act; or
(2) if there is no such name and such drug or such ingredient is an article recognized in an official compendium, then the official title in such compendium or if neither applies, then the common or usual name, if any, of such drug or of such ingredient; provided that where an article is recognized in the United States pharmacopoeia and in the homeopathic pharmacopoeia under different official titles, the official title used in the United States pharmacopoeia shall apply unless it is labeled and offered for sale as a homeopathic drug, in which case the official title used in the homeopathic pharmacopoeia shall apply.
C. A drug or device shall be deemed to be misbranded unless its labeling bears adequate directions for use and such adequate warnings against use in those pathological conditions or by children where its use may be dangerous to health or against unsafe dosage or methods or duration of administration or application, in such manner and form as are necessary for the protection of users; provided that where adequate directions for use as applied to any drug or device are not necessary for the protection of the public health, the board shall promulgate regulations exempting such drug or device from such requirements; provided, further, that articles exempted under regulations issued under Section 502(f) of the federal act may also be exempt.
D. A drug or device shall be deemed to be misbranded if it purports to be a drug the name of which is recognized in an official compendium unless it is packed and labeled as prescribed therein; provided that the method of packing may be modified with the consent of the board. Whenever a drug is recognized in both the United States pharmacopoeia and the homeopathic pharmacopoeia of the United States, it shall be subject to the requirements of the United States pharmacopoeia with respect to packaging and labeling 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; provided, further, that in the event of inconsistency between the requirements of this subsection and those of Paragraph (6) of Subsection A of this section as to the name by which the drug or its ingredients shall be designated, the requirements of Paragraph (6) of Subsection A of this section shall prevail.
E. A drug or device shall be deemed to be misbranded if it has been found by the board or under the federal act to be a drug liable to deterioration unless it is packaged in such form and manner and its label bears the statement of such precautions as the regulations issued by the board or under the federal act require as necessary for the protection of public health. No regulation shall be established for any drug recognized in an official compendium until the board has informed the appropriate body charged with the revision of such compendium of the need for such packaging or labeling requirements and such body has failed within a reasonable time to prescribe such requirements.
F. A drug or device shall be deemed to be misbranded if it is a drug and its container is so made, formed or filled as to be misleading or if it is an imitation of another drug or if it is offered for sale under the name of another drug or if it bears a copy, counterfeit or colorable imitation of a trademark, label, container or identifying name or design of another drug.
G. A drug or device shall be deemed to be misbranded if it is dangerous to health when used in the dosage or with the frequency or duration prescribed, recommended or suggested in the labeling.
H. A drug or device shall be deemed to be misbranded if it is or purports to be or is represented as a drug composed wholly or partly of insulin unless it is from a batch with respect to which a certificate or release has been issued pursuant to Section 506 of the federal act and such certificate or release is in effect with respect to such drug.
I. A drug or device shall be deemed to be misbranded if it is or purports to be or is represented as a drug composed wholly or partly of any kind of penicillin, streptomycin, chlortetracycline, chloramphenicol, bacitracin or any other antibiotic drug or any derivative thereof unless it is from a batch with respect to which a certificate or release has been issued pursuant to Section 507 of the federal act and such certificate or release is in effect with respect to such drug; provided that this subsection shall not apply to any drug or class of drugs exempted by regulations promulgated under Section 507(c) or (d) of the federal act. For the purpose of this subsection, the term "antibiotic drug" means any drug intended for use by man containing any quantity of any chemical substance which is produced by a microorganism and which has the capacity to inhibit or destroy microorganisms in dilute solution, including the chemically synthesized equivalent of any such substance.
J. A drug or device shall be deemed to be misbranded if it is a color additive, the intended use of which in or on drugs is for the purpose of coloring only, unless its packaging and labeling are in conformity with such packaging and labeling requirements applicable to such color additive, prescribed under the provisions of Subsection C of Section 26-1-9 NMSA 1978 or of the federal act.
K. A drug or device shall be deemed to be misbranded, in the case of any dangerous drug distributed or offered for sale in this state, unless the manufacturer, packer, distributor or retailer thereof includes in all advertisements and other descriptive printed matter issued or caused to be issued by the manufacturer, packer or distributor or retailer with respect to that drug a true statement of:
(1) the established name as defined in Paragraph (6) of Subsection A of this section;
(2) the formula showing quantitatively each ingredient of the drug to the extent required for labels under Section 502(e) of the federal act; and
(3) such other information in brief summary relating to side effects and contraindications as are required in regulations issued under the federal act.
L. A drug or device shall be deemed to be misbranded if a trademark, trade name or other identifying mark, imprint or device of another or any likeness of the foregoing has been placed thereon or upon its container with intent to defraud.
M. Drugs and devices which are, in accordance with the practice of the trade, to be processed, labeled or repacked in substantial quantities at establishments other than those where originally packaged in accordance with requirements of the New Mexico Drug, Device and Cosmetic Act shall be deemed to be misbranded unless such drugs or devices are being delivered, manufactured, processed, labeled, repacked or otherwise held in compliance with regulations issued by the board or under the federal act.
N. A dangerous drug, except for drugs declared dangerous pursuant to Subsection B of Section 26-1-18 NMSA 1978, shall be deemed to be misbranded if, at any time prior to dispensing, its label fails to bear either of the following legends:
(1) "Caution: federal law prohibits dispensing without prescription."; or
(2) "RX only".
1953 Comp., § 54-6-36, enacted by Laws 1967, ch. 23, § 11; 1972, ch. 84, § 46; 1975, ch. 103, § 1; 1999, ch. 298, § 2.
NMSA 1978, § 26-1-12 False advertising
26-1-12. False advertising
A. An advertisement of a drug, device or cosmetic shall be deemed to be false if it is false or misleading in any particular.
B. For the purpose of the New Mexico Drug and Cosmetic Act [New Mexico Drug, Device and Cosmetic Act] the advertisement of a drug or device representing it to have any effect in albuminuria, appendicitis, arteriosclerosis, blood poison, bone disease, Bright's disease, cancer, carbuncles, cholecystitis, diabetes, diphtheria, dropsy, erysipelas, gallstones, heart and vascular diseases, high blood pressure, mastoiditis, measles, meningitis, mumps, nephritis, otitis media, paralysis, pneumonia, poliomyelitis (infantile paralysis), prostate gland disorders, pyelitis, scarlet fever, sexual impotence, sinus infection, small pox [smallpox], tuberculosis, tumors, typhoid, uremia, veneral [venereal] disease, shall also be deemed to be false, except that no advertisement not in violation of Subsection A shall be deemed to be false under this subsection if it is disseminated only to members of the pharmacy, medical, dental or veterinary profession or appears only in the scientific periodicals of those professions or is disseminated only for the purpose of public health education by persons not commercially interested, directly or indirectly, in the sale of such drugs or devices; provided, that whenever the board determines that an advance in medical science has made any type of self-medication safe as to any of the diseases named above, [the] board shall by regulation authorize the advertisement of drugs having curative or therapeutic effect for such disease, subject to such conditions and restrictions as the board may deem necessary in the interests of public health; provided, that this subsection shall not be construed as indicating that self-medication for diseases other than those named herein is safe or efficacious.
C. In the case of any dangerous drug distributed or offered for sale in this state by a manufacturer, packer, distributor or retailer, all advertisement with respect to that drug shall contain a true statement of the established or official name, together with any trade or brand name; the formula as represented on the label, in the same order of listing and with all listed warnings and cautions; the dosage form and strength; such other information in brief summary relating to its use, side effects, contraindications and the name of the manufacturer, packer or distributor; provided, that no advertisement prepared in accordance with Section 502(n) of the federal act and disseminated only to practitioners and dispensers shall be in violation of this subsection.
1953 Comp., § 54-6-37, enacted by Laws 1967, ch. 23, § 12.
NMSA 1978, § 26-1-13 Packaging and labeling requirements; proprietary preparations
26-1-13. Packaging and labeling requirements; proprietary preparations
A. The principal display panel of an over-the-counter packaged drug or device shall bear as one of its principal features a statement of the identity of the commodity. The statement shall include the established name of the drug or the common name of the device and an accurate statement of the general pharmacological category of the drug or the principal intended action of the drug or device in terms meaningful to the layman.
B. In the case of an over-the-counter drug that is a mixture with no established name, a conspicuous enumeration of each active ingredient that is a mixture with no established name and a conspicuous enumeration of each active ingredient immediately followed by an accurate statement of the general pharmacological category of the ingredients or of its principal intended action in terms that are meaningful to the layman.
C. This section shall not apply to any drug or class of drugs exempted by regulations promulgated under the federal Fair Packaging and Labeling Act.
D. The label of an over-the-counter packaged drug or device shall bear a declaration of the net quantity of its contents.
E. Dangerous drugs or over-the-counter preparations subject to the federal Poison Prevention Packaging Act of 1970 shall meet the safety closure standards and regulations promulgated pursuant to the federal Poison Prevention Packaging Act of 1970.
1953 Comp., § 54-6-38, enacted by Laws 1972, ch. 84, § 47.
NMSA 1978, § 26-1-14 New drugs and devices; prerequisites to sale, delivery or giving away; exceptions
26-1-14. New drugs and devices; prerequisites to sale, delivery or giving away; exceptions
A. No person shall sell, deliver, offer for sale, hold for sale or give away any new drug or device unless:
(1) an application has been approved for the drug and approval has not been withdrawn under Section 505 of the federal act;
(2) when the drug is not subject to the federal act, the drug has been tested and has been found to be safe for use under the conditions prescribed, recommended or suggested in the labeling, and, prior to selling or offering for sale, there has been filed with the board an application setting forth full reports of investigations which have been made to show whether or not the drug is safe for use; a full list of the articles used as components of the drug; a full statement of the composition of the drug; a full description of the methods used in and the facilities and controls used for the manufacture, processing and packing of the drug; such samples of the drug and of the articles used as components of the drug as the board may require; and specimens of the labeling proposed to be used for the drug; or
(3) the device has met the requirements of classification, performance standards and premarket approval, where applicable, under Sections 513 through 520 of the federal act.
B. An application provided for in Paragraph (2) of Subsection A of this section shall become effective on the one hundred eightieth day after filing except that if the board finds, after due notice to the applicant and giving him an opportunity for a hearing, that the drug is not safe for the use under the conditions prescribed, recommended or suggested in the proposed labeling, it shall, prior to the effective date of application, issue an order refusing to permit the application to become effective.
C. An order refusing to permit an application under this section to become effective may be revoked by the board.
D. This section shall not apply:
(1) to a drug intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety of drugs, provided the drug is plainly labeled in compliance with the regulations issued by the board or pursuant to Section 505(i) or 507(d) of the federal act;
(2) to any drug which is subject to Subsection I of Section 26-1-11 NMSA 1978;
(3) to any device for use pursuant to the order of an individual practitioner qualified by law in this state to use or prescribe the device, which device:
(a) is not generally available in finished form for purchase or for dispensing upon prescription and is not offered through labeling or advertising by the manufacturer for commercial distribution;
(b) is intended for use by an individual patient named in the order of the prescribing practitioner and is to be made in a specific form for the patient or is intended to meet the special needs of the practitioner in the course of the practitioner's professional practice; and
(c) is not generally available to or generally used by other practitioners; or
(4) is exempt under Section 520(g) of the federal act for investigational use by experts qualified by scientific training and experience to test the safety and effectiveness of the device by controlled investigation and evaluation.
1953 Comp., § 54-6-39, enacted by Laws 1967, ch. 23, § 14; 1977, ch. 117, § 2; 1987, ch. 270, § 5.
NMSA 1978, § 26-1-15 Dangerous drugs; veterinary use; limitations
26-1-15. Dangerous drugs; veterinary use; limitations
A. A dangerous drug intended for veterinary use which is not safe for animal use except under the direct supervision of a licensed veterinarian and for which adequate directions for use cannot be prepared, shall bear the legend "CAUTION: federal law restricts this drug to use by or on the order of a licensed veterinarian" and the label shall meet the requirements of the federal act. Such drugs may be sold or distributed by a person possessing a limited license issued by the board under Subsection B of Section 61-11-14 NMSA 1978, on the order of a licensed veterinarian, provided adequate records of receipt and distribution are kept as required in the New Mexico Drug and Cosmetic Act [New Mexico Drug, Device and Cosmetic Act].
B. Drugs which are exempted by the federal act for veterinary use without a prescription shall be labeled to indicate that the drug is for veterinary use and the label shall meet the requirements of the federal act.
1953 Comp., § 54-6-40, enacted by Laws 1972, ch. 84, § 48; 1973, ch. 217, § 1.
NMSA 1978, § 26-1-16 Dangerous drugs; conditions for sale; prescription refilling; limitations
26-1-16. Dangerous drugs; conditions for sale; prescription refilling; limitations
A. It is unlawful for a person to sell, dispose of or possess any dangerous drugs, except:
(1) manufacturers, wholesalers or distributors, their agents or employees licensed by the board to ship dangerous drugs into the state; or
(2) distributors, wholesalers, hospitals, nursing homes, clinics or pharmacies and other authorized retailers of dangerous drugs in this state licensed by the board, and appropriate records of dangerous drugs receipt and disposition are kept. These records shall be open to inspection by any enforcement officer of this state.
B. Practitioners licensed in this state may prescribe, provide samples of and dispense any dangerous drug to a patient where there is a valid practitioner-patient relationship. A record of all such dispensing shall be kept showing the date the drug was dispensed and bearing the name and address of the patient to whom dispensed. It is the duty of every licensed physician, dentist, veterinarian, pharmacist or person holding a limited license issued under Subsection B of Section 61-11-14 NMSA 1978, when dispensing any dangerous drug, to mark on the dispensing container the name of the patient, the date dispensed, the name and address of the person dispensing the drug, the name and strength of the drug, expiration date where applicable, adequate directions for use and the prescription number when applicable. All official compendium requirements for the preservation, packaging, labeling and storage of dangerous drugs are applicable where drugs are held for dispensing to the public, whether by a pharmacy, clinic, hospital or practitioner.
C. Pharmacists are prohibited from selling or dispensing a dangerous drug except on prescription or drug order of a practitioner and except as such sale or possession is authorized under Subsection A of this section. It is the duty of all pharmacists to keep an accurate record of all disposals, which record shall be open to inspection by an enforcement officer of this state.
D. No enforcement officer having knowledge by virtue of office of a prescription, order or record shall divulge such knowledge except in connection with a prosecution or proceeding in court or before a licensing or registration board or officer, to which prosecution or proceeding the person to whom such prescriptions, orders or records relate is a party.
E. It is unlawful, except as otherwise authorized under Subsection A of this section or the Controlled Substances Act [Chapter 30, Article 31 NMSA 1978] and except for the college of pharmacy of the university of New Mexico or a public health laboratory, for a person to possess any dangerous drug unless such substance has been dispensed to the person either directly by a practitioner or on a prescription.
F. All records required to be kept under the provisions of the New Mexico Drug, Device and Cosmetic Act shall be preserved for a period of three years, provided that records requirements do not apply to the administration of a drug to a patient upon whom the practitioner personally attends, and provided that records of controlled substances shall be kept in accordance with the provisions of the Controlled Substances Act.
G. A prescription shall not be filled:
(1) as a refill if it is marked by the issuing practitioner to indicate that the prescription is not to be refilled;
(2) except in compliance with the provisions of the Controlled Substances Act if the drug is a controlled substance;
(3) unless the fill is made in accordance with the provisions of this section; and
(4) when the practitioner does not indicate fill instructions on the original prescription calling for a dangerous drug, unless:
(a) the practitioner is contacted orally, by telephone or other means of communication for instruction; and
(b) if authorization to fill is given the pharmacist, the following information will be immediately transferred to the original prescription: 1) date; 2) name of person authorizing the fill; 3) pharmacist's initials; and 4) amount dispensed if different from the amount indicated on the original prescription.
H. Nothing in this section shall prevent the owner of livestock or the owner's consignee or their employees to be in possession of drugs for their use in performing routine, accepted livestock management practices in the care of livestock belonging to the owner, and the drugs are labeled as being restricted to animal use only; provided, that if such drugs bear the legend: "CAUTION: federal law restricts this drug to use by or on the order of a licensed veterinarian", the drugs may be used or distributed only as provided in Subsection A of Section 26-1-15 NMSA 1978.
I. When, on the original prescription calling for a dangerous drug that is not a controlled substance, a practitioner indicates a specific number of fills or a specific period of time during which a prescription may be filled, a drug may be filled the number of times or for the period of time that the prescription indicates if the following information is provided with the prescription:
(1) the date of fill;
(2) the initials of the pharmacist filling the prescription; and
(3) the amount of drug dispensed, if it differs from the amount called for on the original prescription.
J. A pharmacist may dispense a quantity not to exceed a ninety-day supply of a dangerous drug by combining valid fills when:
(1) an indication on the prescription or label does not specifically prohibit a combined fill; and
(2) the dangerous drug to be filled is not a controlled substance.
K. When the practitioner indicates on the original prescription calling for dangerous drugs that it may be filled "prn", the pharmacist may fill it within the limits of the dosage directions for a period of twelve months, provided the date of filling and the initials of the pharmacist are recorded on the original prescription. At the expiration of the twelve-month period, the practitioner must be contacted for a new prescription; provided that this is not to be construed to apply to those drugs regulated by the Controlled Substances Act.
L. The board may adopt and promulgate regulations to permit the use of computer systems for the storage and retrieval of prescriptions, records for the purpose of filling prescriptions, receipt records, drug distribution records, drug withdrawals from stock, drug compounding records, drug disposition records and drug disposal records.
M. As used in this section, "fill" means a dispensing of a drug for the first time or as a refill.
1953 Comp., § 54-6-41, enacted by Laws 1967, ch. 23, § 16; 1972, ch. 84, § 49; 1973, ch. 217, § 2; 1979, ch. 41, § 1; 1987, ch. 270, § 6; 2005, ch. 152, § 3; 2013, ch. 157, § 2.
NMSA 1978, § 26-1-16.1 Opioids; requiring practitioners to obtain and review reports from the prescription monitoring program
26-1-16.1. Opioids; requiring practitioners to obtain and review reports from the prescription monitoring program
A. For purposes of this section:
(1) "opioid" means the class of drugs that includes the natural derivatives of opium, which are morphine and codeine, and related synthetic and semi-synthetic compounds that act upon opioid receptors;
(2) "practitioner" does not include a pharmacist, veterinarian or euthanasia technician;
(3) "prescription monitoring program" means a program that includes a centralized system to collect, monitor and analyze electronically, for Schedule II through V controlled substances, prescribing and dispensing data submitted by dispensers; and
(4) "Schedule II through V controlled substance" means a substance listed in Schedule II, III, IV or V pursuant to the Controlled Substances Act [Chapter 30, Article 31 NMSA 1978] or the federal controlled substances regulation, pursuant to 21 U.S.C. 812.
B. Before a practitioner prescribes or dispenses an opioid for the first time to a patient, the practitioner shall obtain and review a report from the state's prescription monitoring program for such patient for the previous twelve calendar months. If the practitioner has access to a similar report from an adjacent state for the patient, the practitioner shall also obtain and review that report. The provisions of this subsection shall not apply to the prescription or dispensing of an opioid for a supply of four days or less.
C. A practitioner shall obtain and review a report from the state's prescription monitoring program and similar reports from an adjacent state, if any, no less than once every three months for each established patient for whom the practitioner continuously prescribes or dispenses opioids.
D. A practitioner shall document the receipt and review of reports required by this section in the patient's medical record.
E. Nothing in this section shall be construed to prevent a practitioner from obtaining and reviewing a report regarding a practitioner's patient from the state's prescription monitoring program or a similar report from another state with greater frequency than that required by this section, in accordance with the practitioner's professional judgment.
F. Nothing in this section shall be construed to require a practitioner to obtain a prescription monitoring report when prescribing an opioid to a patient in a nursing facility or in hospice care.
G. The professional licensing board of each category of practitioner that is licensed or otherwise authorized to prescribe or dispense an opioid shall promulgate rules to implement the provisions of this section. Nothing in this section shall be construed to prevent a professional licensing board from requiring by rule that practitioners obtain prescription monitoring program reports with greater frequency than that required by this section.
Laws 2016, ch. 46, § 1.
NMSA 1978, § 26-1-17 Testing laboratory
26-1-17. Testing laboratory
The college of pharmacy of the university of New Mexico shall serve as the testing laboratory for samples collected for examination pursuant to the provisions of the New Mexico Drug and Cosmetic Act [New Mexico Drug, Device and Cosmetic Act].
1953 Comp., § 54-6-42, enacted by Laws 1967, ch. 23, § 17.
NMSA 1978, § 26-1-18 Promulgating regulations; procedure
26-1-18. Promulgating regulations; procedure
A. The board may promulgate regulations for the efficient enforcement of the New Mexico Drug, Device and Cosmetic Act. The board shall conform the regulations promulgated under the New Mexico Drug, Device and Cosmetic Act, insofar as practical, with regulations promulgated under the federal act as defined in Section 26-1-2 NMSA 1978.
B. The board shall, by regulation, declare a substance a "dangerous drug" when necessary, and notification shall be sent to all registered pharmacies in the state within sixty days of the adoption of the regulation.
C. The board shall promulgate the requirements for a pedigree.
D. All regulations promulgated by the board shall be in accordance with the Uniform Licensing Act.
1953 Comp., § 54-6-43, enacted by Laws 1972, ch. 84, § 50; 2005, ch. 152, § 6.
NMSA 1978, § 26-1-18.1 Prescription drug prior authorization protocols
26-1-18.1. Prescription drug prior authorization protocols
A. After January 1, 2014, a prescribing practitioner seeking prior authorization from a health insurer may use the uniform prior authorization form developed pursuant to Sections 2 [59A-2-9.8 NMSA 1978] and 3 [61-11-6.2 NMSA 1978] of this 2013 act.
B. As used in this section:
(1) "health insurer" means a health insurer; a nonprofit health service provider; a health maintenance organization; a managed care organization; or a provider service organization. "Health insurer" does not include:
(a) a person that delivers, issues for delivery or renews an individual policy intended to supplement major medical group-type coverages such as medicare supplement, long-term care, disability income, specified disease, accident-only, hospital indemnity or other limited-benefit health insurance policy;
(b) a physician or a physician group to which a health insurer has delegated financial risk for prescription drugs and that does not use a prior authorization process for prescription drugs; or
(c) a health insurer or its affiliated providers if the health insurer owns and operates its pharmacies and does not use a prior authorization process for prescription drugs; and
(2) "prescribing practitioner" means a person that is licensed or certified to prescribe and administer drugs that are subject to the New Mexico Drug, Device and Cosmetic Act.
Laws 2013, ch. 170, § 4.
NMSA 1978, § 26-1-19 Power to make inspections and secure samples
26-1-19. Power to make inspections and secure samples
The board or its duly authorized agent shall have free access at all reasonable hours to any factory, warehouse or establishment in which drugs, devices or cosmetics are manufactured, processed, packed or held for introduction into commerce, or to enter any vehicle being used to transport or hold such drugs, devices or cosmetics in commerce, for the purpose of inspecting such factory, warehouse, establishment or vehicle to determine if any of the provisions of the New Mexico Drug and Cosmetic Act [New Mexico Drug, Device and Cosmetic Act] are being violated, and to secure samples or specimens of any drug, device or cosmetic after paying or offering to pay for such sample. It shall be the duty of the board to make or cause to be made examinations of samples secured under the provisions of this section to determine whether or not any provision of the New Mexico Drug and Cosmetic Act [New Mexico Drug, Device and Cosmetic Act] is being violated.
1953 Comp., § 54-6-44, enacted by Laws 1967, ch. 23, § 19.
NMSA 1978, § 26-1-20 Personnel
26-1-20. Personnel
The board shall employ such personnel for the administration and enforcement of the provisions of the New Mexico Drug and Cosmetic Act [New Mexico Drug, Device and Cosmetic Act] as may be necessary.
1953 Comp., § 54-6-45, enacted by Laws 1967, ch. 23, § 20.
NMSA 1978, § 26-1-21 Power of board to publish reports and disseminate information
26-1-21. Power of board to publish reports and disseminate information
A. The board may cause to be published from time to time reports summarizing all judgments, decrees and court orders which have been rendered, including the nature of the charge and the disposition thereof.
B. The board may also cause to be disseminated such information regarding drugs, devices and cosmetics as the board deems necessary in the interest of the public health and the protection of the consumer against fraud. Nothing in this section shall be construed to prohibit the board from collecting, reporting and illustrating the results of the investigations of the board.
1953 Comp., § 54-6-46, enacted by Laws 1967, ch. 23, § 21.
NMSA 1978, § 26-1-22 Unlawful means of obtaining dangerous drugs enumerated
26-1-22. Unlawful means of obtaining dangerous drugs enumerated
It shall be unlawful for any person to obtain or attempt to obtain any dangerous drug or to procure or attempt to procure the administration of any dangerous drugs other than a controlled substance:
A. by fraud, deceit, misrepresentation or subterfuge; or
B. by forgery or alteration of a prescription or of any written order; or
C. by the concealment of a material fact; or
D. by the use of a false name or the giving of a false name or the giving of a false address.
1953 Comp., § 54-6-47, enacted by Laws 1967, ch. 23, § 22; 1972, ch. 84, § 51.
NMSA 1978, § 26-1-23 False statements; false pretenses; forgery of labels or prescriptions prohibited
26-1-23. False statements; false pretenses; forgery of labels or prescriptions prohibited
It shall be unlawful for any person to:
A. willfully make a false statement in any prescription, order, report or record required by the New Mexico Drug and Cosmetic Act [New Mexico Drug, Device and Cosmetic Act];
B. falsely assume the title of or represent himself to be a manufacturer, wholesaler, pharmacist, physician, dentist, veterinarian or other authorized person for the purpose of obtaining any of the dangerous drugs;
C. make or utter any false or forged label to a package containing any of the dangerous drugs; or
D. make or utter any false or forged prescription or false or forged written order for dangerous drugs other than controlled substances.
1953 Comp., § 54-6-48, enacted by Laws 1967, ch. 23, § 23; 1972, ch. 84, § 52.
NMSA 1978, § 26-1-24 Cosmetics; misbranding
26-1-24. Cosmetics; misbranding
A cosmetic shall be deemed to be misbranded:
A. if its labeling is false or misleading in any particular;
B. if in package form unless it bears a label containing:
(1) the name and place of business of the manufacturer, packer or distributor; and
(2) an accurate statement of the quantity of the contents in terms of weight, measure or numerical count; provided, that reasonable variations shall be permitted, and exemptions made for information pertaining to weight, measure or numerical count as to small packages, shall be established by regulations prescribed by the board;
C. if any word, statement or other information required by or under the authority of the New Mexico Drug and Cosmetic Act [New Mexico Drug, Device and Cosmetic Act] to appear on the label or labeling is not prominently placed thereon with such conspicuousness as compared with other words, statements, designs or devices, in the labeling, and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of the purchase and use;
D. if its container is so made, formed or filled as to be misleading; or
E. if it is a color additive, unless its packaging and labeling are in conformity with such packaging and labeling requirements applicable to such color additive prescribed under the provisions of the federal act. This section shall not apply to packages of color additives which, with respect to their use for cosmetics, are marketed and intended for use only in or on hair dyes bearing required label.
1953 Comp., § 54-6-49, enacted by Laws 1967, ch. 23, § 24.
NMSA 1978, § 26-1-25 Cosmetics; adulteration
26-1-25. Cosmetics; adulteration
A cosmetic shall be deemed to be adulterated:
A. if it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling or advertisements thereof, or under such conditions of use as are customary or usual; provided, that this provision shall not apply to coal-tar dye, the label of which bears the following legend conspicuously displayed thereon: "CAUTION: This product contains ingredients which may cause skin irritations on certain individuals and a preliminary test according to accompanying directions should first be made. This product must not be used for dyeing the eyelashes or eyebrows; to do so may cause blindness," and the labeling of which bears adequate directions for such preliminary testing. For the purpose of this paragraph and Subsection E the term "hair dye" shall not include eyelash dyes or eyebrow dyes;
B. if it consists in whole or in part of any filthy, putrid or decomposed substance;
C. if it has been produced, prepared, packed or held under unsanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health;
D. if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or
E. if it is not a hair dye, and it bears or contains a color additive which is unsafe within the meaning of the federal act.
1953 Comp., § 54-6-50, enacted by Laws 1967, ch. 23, § 25.
NMSA 1978, § 26-1-26 Penalties
26-1-26. Penalties
A. Any person who knowingly violates any of the provisions of Subsection A, B, C, F, G or H of Section 26-1-3, Section 26-1-14, 26-1-16, 26-1-22 or 26-1-23 NMSA 1978 is guilty of a fourth degree felony and shall be punished by a fine of not less than one thousand dollars ($1,000) or more than five thousand dollars ($5,000) or by imprisonment for not less than one year or both.
B. Except as provided in Subsection A of this section, any person violating any of the provisions of the New Mexico Drug, Device and Cosmetic Act is guilty of a misdemeanor for the first offense and for second and subsequent offenses is guilty of a fourth degree felony.
1953 Comp., § 54-6-51, enacted by Laws 1967, ch. 23, § 26; 1971, ch. 245, § 4; 1972, ch. 84, § 53; 1987, ch. 270, § 7.
NMSA 1978, § 26-1-27 Prohibition of discrimination against 340B entities
26-1-27. Prohibition of discrimination against 340B entities
A. As used in this section:
(1) "340B drug" means a drug that is purchased at a discount in accordance with the 340B program requirements;
(2) "340B program" means the federal drug pricing program created pursuant to 42 U.S.C. Section 256b;
(3) "affiliate" means a person that directly or indirectly controls, is controlled by or is under common control with a manufacturer;
(4) "applicable entity" means an organization that receives federal grant funding and is recognized by the federal health resources and services administration as a federally qualified health center or a federally qualified health center lookalike; and
(5) "manufacturer" means an entity licensed to manufacture prescription drugs pursuant to the Pharmacy Act [Chapter 61, Article 11 NMSA 1978].
B. A manufacturer, a manufacturer's agent or an affiliate of a manufacturer shall not directly or indirectly:
(1) deny, restrict, prohibit or interfere with the acquisition of a 340B drug by, or delivery of a 340B drug to, a pharmacy contractually obligated with an applicable entity and is authorized to receive and dispense 340B drugs on behalf of the applicable entity unless receipt of the 340B drugs is prohibited by the United States department of health and human services;
(2) interfere with the ability of a pharmacy contracted with an applicable entity to dispense 340B drugs to the applicable entity's eligible patients; or
(3) require an applicable entity to submit any claims, utilization, purchasing or other data as a condition for allowing the acquisition of a 340B drug by, or delivery of a 340B drug to, an applicable entity unless the sharing of claims or utilization data is required by federal law.
Laws 2025, ch. 91, § 1.
Source: New Mexico Compilation Commission (nmonesource.com)URL: https://nmonesource.com/nmos/nmsa-unanno/en/item/18526/index.doFetched: 10/20/2026