§ 6802 — Definitions

New York § 6802

• Jurisdiction: New York
• Law EDN: Education
• Title 8: The Professions
• Art. 137: Pharmacy

Text

§ 6802. Definitions. 1. "Pharmacy" means any place in which drugs,\nprescriptions or poisons are possessed for the purpose of compounding,\npreserving, dispensing or retailing, or in which drugs, prescriptions or\npoisons are compounded, preserved, dispensed or retailed, or in which\nsuch drugs, prescriptions or poisons are by advertising or otherwise\noffered for sale at retail.\n 3. "Formulary" means the latest edition of the official national\nformulary, and its supplement.\n 4. "Pharmacopeia", when not otherwise limited, means the latest\nedition of the official United States pharmacopeia, and its supplement.\n 5. "Homeopathic pharmacopeia" means the official homeopathic\npharmacopeia of the United States, and its supplement.\n 6. "Official compendium" means the official United States\npharmacopeia, official homeopathic pharmacopeia of the United States,\nofficial national formulary, or their supplements.\n 7. "Drugs" means:\n a. Articles recognized in the official United States pharmacopeia,\nofficial homeopathic pharmacopeia of the United States, or official\nnational formulary.\n b. Articles intended for use in the diagnosis, cure, mitigation,\ntreatment or prevention of disease in man or animals.\n c. Articles (other than food) intended to affect the structure or any\nfunction of the body of man or animals.\n d. Articles intended for use as a component of any article specified\nin paragraphs a, b, or c; but does not include devices or their\ncomponents, parts or accessories.\n 8. "Cosmetics" means:\n a. Articles intended to be rubbed, poured, sprinkled or sprayed on,\nintroduced into or otherwise applied to the human body for cleansing,\nbeautifying, promoting attractiveness, or altering the appearance.\n b. Articles intended for use as a component of any such articles;\nexcept that the term shall not include soap.\n 9. "Poison", where not otherwise limited, means any drug, chemical or\npreparation likely to be destructive to adult human life in quantity of\nsixty grains or less.\n 10. "Label" means a display of written, printed or pictorial matter\nupon the immediate container of any drug, device or cosmetic. Any\nrequirement made by or under authority of this article, that any word,\nstatement, or other information appear on the label shall not be\nconsidered to be complied with unless such word, statement or other\ninformation also appears on the outside container or wrapper, if there\nbe any, of the retail package of such drug, device or cosmetic or is\neasily legible through the outside container or wrapper.\n 11. "Immediate container" does not include package liners.\n 12. "Labeling" means all labels and other written, printed or\npictorial matter:\n a. Upon any drug, device or cosmetic or any of its containers or\nwrappers, or\n b. Accompanying such drug, device or cosmetic.\n 13. "Misbranding". If a drug, device or cosmetic is alleged to be\nmisbranded because the labeling is misleading, or if an advertisement is\nalleged to be false because it is misleading then in determining whether\nthe labeling or advertisement is misleading there shall be taken into\naccount (among other things) not only representations made or suggested\nby statement, word, design, device, sound or any combination thereof,\nbut also the extent to which the labeling fails to reveal facts material\nin the light of such representations or material with respect to\nconsequences which may result from the use of the drug, device, or\ncosmetic to which the labeling or advertising relates under the\nconditions of use prescribed in the labeling or advertising thereof or\nunder such conditions of use as are customary or usual. No drug, device\nor cosmetic which is subject to, and complies with regulations\npromulgated under the provisions of the federal food, drug, and cosmetic\nact, relating to adulteration and misbranding shall be deemed to be\nadulterated or misbranded in violation of the provisions of this article\nbecause of its failure to comply with the board's regulations, or the\nrules of the state board of pharmacy, insofar as the regulations are in\nconflict with regulations relating to adulteration and misbranding under\nthe federal food, drug and cosmetic act.\n 14. "Antiseptic". The representation of a drug, device or cosmetic in\nits labeling, as an antiseptic, shall be considered to be a\nrepresentation that it is a germicide, except in the case of a drug\npurporting to be, or represented as, an antiseptic for inhibitory use as\na wet dressing, ointment, dusting powder, or such other use as involves\nprolonged contact with the body.\n 15. "New drug" means:\n a. Any drug not generally recognized, among experts qualified by\nscientific training and experience to evaluate the safety and\neffectiveness of drugs, as safe and effective for use under the\nconditions prescribed, recommended or suggested by the drug's labeling,\nexcept that such a drug not so recognized shall not be deemed to be a\n"new drug" if at any time prior to September first, nineteen hundred\nthirty-nine it was subject to the former federal food and drug act of\nJune thirtieth, nineteen hundred six, as amended, and if at such time\nits labeling contained the same representations concerning the\nconditions of its use;\n b. Any drug, the composition of which is such that the drug, as a\nresult of investigations to determine its safety and effectiveness for\nuse under such conditions, has become recognized, but which has not\notherwise than in such investigations been used to a material extent or\nfor a material time under such conditions.\n 16. "Device" means instruments, apparatus, and contrivances, including\ntheir components, parts and accessories, intended:\n a. For use in the diagnosis, cure, mitigation, treatment, or\nprevention of disease in man or animals; or\n b. To affect the structure or any function of the body of man or\nanimals.\n 17. The term "Federal Food, Drug and Cosmetic Act" means the Federal\nFood, Drug, and Cosmetic Act of the United States of America, approved\nJune twenty-fifth, nineteen hundred thirty-eight, officially cited as\npublic document number seven hundred seventeen-seventy-fifth congress\n(chapter six hundred seventy-five--third session), and all its\namendments now or hereafter enacted.\n 18. "Wholesaler" means a person who bottles, packs or purchases drugs,\ndevices or cosmetics for the purpose of selling or reselling to\npharmacies or to other channels as provided in this article.\n 19. "Advertisement" means all representations disseminated in any\nmanner or by any means, other than by labeling, for the purpose of\ninducing, or which are likely to induce, directly or indirectly, the\npurchase of drugs, devices or cosmetics.\n 20. "Controlled substance" means any drug defined as a controlled\nsubstance by article thirty-three of the public health law.\n 21. "Manufacturer" means a person who compounds, mixes, prepares,\nproduces, and bottles or packs drugs, cosmetics or devices for the\npurpose of distributing or selling to pharmacies or to other channels of\ndistribution.\n 22. "Administer", for the purpose of section sixty-eight hundred one\nof this article, means:\n a. (1) the direct application of an immunizing agent to adults,\nwhether by injection, ingestion, inhalation or any other means, pursuant\nto a patient specific order or non-patient specific regimen prescribed\nor ordered by a physician or certified nurse practitioner, for:\nimmunizations to prevent influenza, pneumococcal, acute herpes zoster,\nhepatitis A, hepatitis B, human papillomavirus, measles, mumps, rubella,\nvaricella, COVID-19, meningococcal, tetanus, diphtheria or pertussis\ndisease and medications required for emergency treatment of anaphylaxis;\nand other immunizations recommended by the advisory committee on\nimmunization practices of the centers for disease control and prevention\nfor patients eighteen years of age or older if the commissioner of\nhealth in consultation with the commissioner determines that an\nimmunization: (i)(A) may be safely administered by a licensed pharmacist\nwithin their lawful scope of practice; and (B) is needed to prevent the\ntransmission of a reportable communicable disease that is prevalent in\nNew York state; or (ii) is a recommended immunization for such patients\nwho: (A) meet age requirements, (B) lack documentation of such\nimmunization, (C) lack evidence of past infection, or (D) have an\nadditional risk factor or another indication as recommended by the\nadvisory committee on immunization practices of the centers for disease\ncontrol and prevention. If the commissioner of health determines that\nthere is an outbreak of disease, or that there is the imminent threat of\nan outbreak of disease, then the commissioner of health may issue a\nnon-patient specific regimen applicable statewide.\n (2) the direct application of an immunizing agent to children between\nthe ages of two and eighteen years of age, whether by injection,\ningestion, inhalation or any other means, pursuant to a patient specific\norder or non-patient specific regimen prescribed or ordered by a\nphysician or certified nurse practitioner, for immunization to prevent\ninfluenza and medications required for emergency treatment of\nanaphylaxis resulting from such immunization. If the commissioner of\nhealth determines that there is an outbreak of influenza, or that there\nis the imminent threat of an outbreak of influenza, then the\ncommissioner of health may issue a non-patient specific regimen\napplicable statewide.\n b. The injection of medications for the treatment of mental health and\nsubstance use disorder, as prescribed or ordered by a licensed\nprescriber, acting within the scope of their practice in this state and\nin accordance with regulations promulgated by the commissioner, in\nconsultation with the department of health and any other state agencies\nas necessary, provided that:\n (1) Such administration is conducted pursuant to a valid\npatient-specific prescription or patient-specific order that authorizes\na pharmacist to administer medications approved by the U.S. Food and\nDrug Administration for the treatment of mental health and substance use\ndisorder. The pharmacist shall notify the licensed prescriber that the\nadministration is complete within five days and shall convey such\ninformation to the prescriber by making an entry into an interoperable\nelectronic medical records system, an electronic prescribing technology\nor a pharmacy record, or by using facsimile, electronic transmission or\nother electronic means. If an electronic means described in this\nsubparagraph is not available to the pharmacist at the time of\ncommunication, the pharmacist or pharmacist's designee may communicate\nthe information by telephone. Notification shall also be required if a\npatient does not receive an administration or if the patient experiences\nany side effects or adverse reactions to the medications. Administration\nin a pharmacy shall not commence until after the patient has received\nthe initial injection and is considered eligible for maintenance\ntreatment by the licensed prescriber.\n (2) Such prescription may be subject to reassessment at appropriate\nintervals, as determined by the licensed prescriber.\n (3) Such activity is conducted in accordance with regulations,\npromulgated or adopted by the commissioner, in consultation with the\ndepartment of health and any other state agencies, as necessary, which\nshall include requirements for the following:\n (i) Maintaining continued competency regarding the populations served\nand medications administered.\n (ii) Pre-administration patient consent and education regarding common\nside effects, drug interactions, injection site reactions and other\ninformation routinely provided to patients upon dispensing. If a patient\nis unable to provide consent, the pharmacist must obtain consent from a\nperson legally responsible when the recipient is incapable of\nconsenting.\n (iii) When administering an injection in a pharmacy, the pharmacist\nshall provide an area for the injection that provides for the patient's\nprivacy.\n (iv) Ensuring that only U.S. Food and Drug Administration approved\nmedications are administered.\n 23. "Electronic prescription" means a prescription created, recorded,\nor stored by electronic means; issued with an electronic signature; and\ntransmitted by electronic means, in accordance with regulations of the\ncommissioner and applicable regulations of the commissioner of health\nand federal regulations; provided, however, that an original hard copy\nprescription that is created electronically or otherwise may be\ntransmitted from the prescriber to the pharmacist by facsimile and must\nbe manually signed. "Electronic" means of or relating to technology\nhaving electrical, digital, magnetic, wireless, optical,\nelectromagnetic, or similar capabilities. "Electronic signature" means\nan electronic sound, symbol, or process, attached to or logically\nassociated with an electronic prescription and executed or adopted by a\nperson with the intent to sign the prescription, in accordance with\nregulations of the commissioner and applicable regulations of the\ncommissioner of health and federal regulations.\n 24. "Compounding" means the combining, admixing, mixing, diluting,\npooling, reconstituting, or otherwise altering of a drug or bulk drug\nsubstance to create a drug with respect to an outsourcing facility under\nsection 503B of the Federal Food, Drug and Cosmetic Act and further\ndefined in this section.\n 25. "Outsourcing facility" means a facility that:\n (a) is engaged in the compounding of sterile drugs;\n (b) is currently registered as an outsourcing facility with the\nSecretary of Health and Human Services; and\n (c) complies with all applicable requirements of federal and state\nlaw, including the Federal Food, Drug and Cosmetic Act.\n 26. "Sterile drug" means a drug that is intended for parenteral\nadministration, an ophthalmic or oral inhalation drug in aqueous format,\nor a drug that is required to be sterile under federal or state law.\n 27. "Biological product" means a biological product as defined in\nsubsection (i) of section 351 of the Public Health Service Act, 42\nU.S.C. Section 262(i).\n 28. "Interchangeable biological product" means a biological product\nlicensed by the United States Food and Drug Administration pursuant to\n42 U.S.C. Section 262(k)(4) as set forth in the latest edition or\nsupplement of the United States Food and Drug Administration Lists of\nLicensed Biological Products with Reference Product Exclusivity and\nBiosimilarity or Interchangeability Evaluations, sometimes referred to\nas the "Purple Book," or a biological product determined by the United\nStates Food and Drug Administration to be therapeutically equivalent as\nset forth in the latest edition or supplement of the United States Food\nand Drug Administration Approved Drug Products with Therapeutic\nEquivalence Evaluations, sometimes referred to as the "Orange Book."\n 29. "Self-administered hormonal contraceptives", for the purpose of\nsection sixty-eight hundred one of this article, means self-administered\ncontraceptive medications or devices approved by the federal Food and\nDrug Administration to prevent pregnancy by using hormones to regulate\nor prevent ovulation, and includes oral hormonal contraceptives,\nhormonal contraceptive vaginal rings and hormonal contraceptive patches.\n * (30) "Shared pharmacy services" means a system that allows a\nregistered pharmacist or a registered pharmacy, pursuant to a request\nfrom another registered pharmacist or pharmacy, to process or fill a\nprescription or order, pursuant to regulations promulgated by the\ncommissioner.\n * NB Effective May 22, 2026\n