Article 137, Pharmacy

This article applies to the profession of pharmacy. The general provisions for all professions contained in article one hundred thirty of this title apply to this article.

1. No person engaged in the business of selling cosmetics shall provide for the use by or application to customers of any cosmetics, except for use or application to the hand or arm as a sample if such immediate container of cosmetics is to be used by or applied to more than one customer. For the purposes of this section, the term "cosmetic" shall not include perfume or cologne; or samples removed from the immediate container with a single use disposable applicator furnished to each customer; or samples dispensed from a tube, pump, spray or shaker container; or samples or applicators that have been cleansed before each use or application. The provisions of this section shall be deemed to have been satisfied if written instructions on the use or application of cosmetic samples pursuant to this section are clearly and visibly posted at or near the place of display of cosmetic samples. Nothing contained in this section shall prohibit the use or application of cosmetic samples by persons trained to apply cosmetics to customers in accordance with the provisions of this section.
2. Notwithstanding any other provision of this article, a violation of this section shall result in a civil penalty of one hundred dollars for the first offense and a civil penalty of two hundred fifty dollars for a second or subsequent offense.

1. The practice of the profession of pharmacy is defined as the administering, preparing, compounding, preserving, or the dispensing of drugs, medicines and therapeutic devices on the basis of prescriptions or other legal authority, and collaborative drug therapy management in accordance with the provisions of section sixty-eight hundred one-a of this article.
2. A licensed pharmacist may execute a non-patient specific regimen prescribed or ordered by a physician licensed in this state or nurse practitioner certified in this state, pursuant to rules and regulations promulgated by the commissioner. When a licensed pharmacist administers an immunizing agent, he or she shall:
   1. report such administration by electronic transmission or facsimile to the patient's attending primary health care practitioner or practitioners, if any, and, to the extent practicable, make himself or herself available to discuss the outcome of such immunization, including any adverse reactions, with the attending primary health care practitioner, and to the statewide immunization registry or the citywide immunization registry, as established pursuant to and to the extent permitted by section twenty-one hundred sixty-eight of the public health law; and
   2. provide information to the patient or, where applicable, the person legally responsible for the patient, on the importance of having a primary health care practitioner, developed by the commissioner of health; and
   3. report such administration, absent of any individually identifiable health information, to the department of health in a manner required by the commissioner of health; and
   4. prior to administering the immunization, inform the patient or, where applicable, the person legally responsible for the patient, of the total cost of the immunization or immunizations, subtracting any health insurance subsidization, if applicable. In the case the immunization is not covered, the pharmacist must inform the patient or, where applicable, the person legally responsible for the patient, of the possibility that the immunization may be covered when administered by a primary care physician or practitioner; and
   5. administer the immunization or immunizations according to the most current recommendations by the advisory committee for immunization practices (ACIP), provided however, that a pharmacist may administer any immunization authorized under this section when specified by a patient specific order.
3. No pharmacist shall administer immunizing agents without receiving training satisfactory to the commissioner and the commissioner of health which shall include, but not be limited to, techniques for screening individuals and obtaining informed consent; techniques of administration; indications, precautions and contraindications in the use of agent or agents; record keeping of immunization and information; and handling emergencies, including anaphylaxis and needlesticks.
4. When administering an immunization in a pharmacy, the licensed pharmacist shall provide an area for the immunization that provides for a patient's privacy. The privacy area should include:
   1. a clearly visible posting of the most current "Recommended Adult Immunization Schedule" published by the advisory committee for immunization practices (ACIP); and
   2. education materials on influenza vaccinations for children as determined by the commissioner and the commissioner of health.
5. A licensed pharmacist may execute a non-patient specific order, for dispensing up to a seven day starter pack of HIV post-exposure prophylaxis medications for the purpose of preventing human immunodeficiency virus infection, by a physician licensed in this state or nurse practitioner certified in this state, pursuant to rules and regulations promulgated by the commissioner in consultation with the commissioner of health following a potential human immunodeficiency virus exposure.
6. A licensed pharmacist may execute a non-patient-specific regimen of insulin and related supplies to an individual who has a valid prescription for insulin and related supplies which has since expired within the last twelve months. The valid prescription must have been prescribed or ordered by a physician licensed in this state or nurse practitioner certified in this state. Execution of a non-patient-specific regimen shall be on an emergency basis provided the pharmacist:
   1. first attempts to obtain an authorization from the prescriber of the patient-specific prescription and cannot obtain the authorization, and the prescriber does not object to dispensing to the patient under the non-patient-specific regimen;
   2. provides a refill of the patient-specific prescription and the quantity of that refill is in conformity with the directions for use under the patient-specific prescription, but limited to an amount not to exceed a thirty-day emergency supply; and
   3. notifies, within seventy-two hours of dispensing the refill or refills, the prescriber of the patient-specific prescription whose authorization could not be obtained, that an emergency prescription of insulin has been dispensed.
7. *A licensed pharmacist is a qualified health care professional under section five hundred seventy-one of the public health law for the purposes of directing a limited service laboratory and ordering and administering COVID-19 and influenza tests authorized by the Food and Drug Administration (FDA), subject to certificate of waiver requirements established pursuant to the federal clinical laboratory improvement act of nineteen hundred eighty-eight.
   * NB Repealed April 9, 2024
8. *A licensed pharmacist within their lawful scope of practice may administer injectable medications into the deltoid muscle, pursuant to section six thousand eight hundred two of this article, for the treatment of mental health and substance use disorder, as prescribed or ordered by a licensed prescriber, acting within their scope of practice in this state and in accordance with regulations, including but not limited to regulations promulgated by the commissioner in consultation with any other state agencies, as necessary.
   * NB Effective December 28, 2023

The board shall promulgate regulations exempting from any labeling requirement of this article drugs, devices and cosmetics 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 processed or packed, on condition that such drugs, devices and cosmetics are not adulterated or misbranded under the provisions of this article upon removal from such processing, labeling, or repacking establishment.

1. As used in this section, the following terms shall have the following meanings:
   1. "Board" shall mean the state board of pharmacy as established by section sixty-eight hundred four of this article.
   2. "Clinical services" shall mean the collection and interpretation of patient data for the purpose of initiating, modifying and monitoring drug therapy with associated accountability and responsibility for outcomes in a direct patient care setting.
   3. "Collaborative drug therapy management" shall mean the performance of clinical services by a pharmacist relating to the review, evaluation and management of drug therapy to a patient, who is being treated by a physician for a specific disease or associated disease states, in accordance with a written agreement or protocol with a voluntarily participating physician and in accordance with the policies, procedures, and protocols of the facility. Such agreement or protocol as entered into by the physician and a pharmacist, may include, and shall be limited to:
      1. adjusting or managing a drug regimen of a patient, pursuant to a patient specific order or protocol made by the patient's physician, which may include adjusting drug strength, frequency of administration or route of administration. Adjusting the drug regimen shall not include substituting or selecting a different drug which differs from that initially prescribed by the patient's physician unless such substitution is expressly authorized in the written order or protocol. The pharmacist shall be required to immediately document in the patient record changes made to the patient's drug therapy and shall use any reasonable means or method established by the facility to notify the patient's other treating physicians with whom he or she does not have a written agreement or protocol regarding such changes. The patient's physician may prohibit, by written instruction, any adjustment or change in the patient's drug regimen by the pharmacist;
      2. evaluating and, only if specifically authorized by the protocol and only to the extent necessary to discharge the responsibilities set forth in this section, ordering disease state laboratory tests related to the drug therapy management for the specific disease or disease state specified within the written agreement or protocol; and
      3. only if specifically authorized by the written agreement or protocol and only to the extent necessary to discharge the responsibilities set forth in this section, ordering or performing routine patient monitoring functions as may be necessary in the drug therapy management, including the collecting and reviewing of patient histories, and ordering or checking patient vital signs, including pulse, temperature, blood pressure and respiration.
   4. "Facility" shall mean:
      1. a teaching hospital or general hospital, including any diagnostic center, treatment center, or hospital-based outpatient department as defined in section twenty-eight hundred one of the public health law; or
      2. a nursing home with an on-site pharmacy staffed by a licensed pharmacist; provided, however, for the purposes of this section the term "facility" shall not include dental clinics, dental dispensaries, residential health care facilities and rehabilitation centers. For the purposes of this section, a "teaching hospital" shall mean a hospital licensed pursuant to article twenty-eight of the public health law that is eligible to receive direct or indirect graduate medical education payments pursuant to article twenty-eight of the public health law.
   5. "Physician" shall mean the physician selected by or assigned to a patient, who has primary responsibility for the treatment and care of the patient for the disease and associated disease states that are the subject of the collaborative drug therapy management.
   6. "Written agreement or protocol" shall mean a written document, pursuant to and consistent with any applicable state or federal requirements, that addresses a specific disease or associated disease states and that describes the nature and scope of collaborative drug therapy management to be undertaken by the pharmacists, in collaboration with the participating physician in accordance with the provisions of this section.
2.  
   1. A pharmacist who meets the experience requirements of paragraph b of this subdivision and who is employed by or otherwise affiliated with a facility shall be permitted to enter into a written agreement or protocol with a physician authorizing collaborative drug therapy management, subject to the limitations set forth in this section, within the scope of such employment or affiliation.
   2. A participating pharmacist must:
      1. (A) have been awarded either a master of science in clinical pharmacy or a doctor of pharmacy degree; (B) maintain a current unrestricted license; and (C) have a minimum of two years experience, of which at least one year of such experience shall include clinical experience in a health facility, which involves consultation with physicians with respect to drug therapy and may include a residency at a facility involving such consultation; or
      2. (A) have been awarded a bachelor of science in pharmacy; (B) maintain a current unrestricted license; and (C) within the last seven years, have a minimum of three years experience, of which at least one year of such experience shall include clinical experience in a health facility, which involves consultation with physicians with respect to drug therapy and may include a residency at a facility involving such consultation; and (iii) meet any additional education, experience, or other requirements set forth by the department in consultation with the board.
   3. Notwithstanding any provision of law, nothing in this section shall prohibit a licensed pharmacist from engaging in clinical services associated with collaborative drug therapy management, in order to gain experience necessary to qualify under clause (C) of subparagraph (i) or (ii) of paragraph b of this subdivision, provided that such practice is under the supervision of a pharmacist that currently meets the referenced requirement, and that such practice is authorized under the written agreement or protocol with the physician.
   4. Notwithstanding any provision of this section, nothing herein shall authorize the pharmacist to diagnose disease. In the event that a treating physician may disagree with the exercise of professional judgment by a pharmacist, the judgment of the treating physician shall prevail.
3. The physician who is a party to a written agreement or protocol authorizing collaborative drug therapy management shall be employed by or otherwise affiliated with the same facility with which the pharmacist is also employed or affiliated.
4. The existence of a written agreement or protocol on collaborative drug therapy management and the patient's right to choose to not participate in collaborative drug therapy management shall be disclosed to any patient who is eligible to receive collaborative drug therapy management. Collaborative drug therapy management shall not be utilized unless the patient or the patient's authorized representative consents, in writing, to such management. If the patient or the patient's authorized representative consents, it shall be noted on the patient's medical record. If the patient or the patient's authorized representative who consented to collaborative drug therapy management chooses to no longer participate in such management, at any time, it shall be noted on the patient's medical record. In addition, the existence of the written agreement or protocol and the patient's consent to such management shall be disclosed to the patient's primary physician and any other treating physician or healthcare provider.
5. Participation in a written agreement or protocol authorizing collaborative drug therapy management shall be voluntary, and no patient, physician, pharmacist, or facility shall be required to participate.
6. Nothing in this section shall be deemed to limit the scope of practice of pharmacy nor be deemed to limit the authority of pharmacists and physicians to engage in medication management prior to the effective date of this section and to the extent authorized by law.

* NB Repealed July 1, 2022

The board shall promulgate regulations providing for the listing of coal-tar colors which are harmless and suitable for use in drugs for purposes of coloring only and for use in cosmetics and for the certification of batches of such colors, with or without harmless diluents.

1. "Pharmacy" means any place in which drugs, prescriptions or poisons are possessed for the purpose of compounding, preserving, dispensing or retailing, or in which drugs, prescriptions or poisons are compounded, preserved, dispensed or retailed, or in which such drugs, prescriptions or poisons are by advertising or otherwise offered for sale at retail.

3. "Formulary" means the latest edition of the official national formulary, and its supplement.
4. "Pharmacopeia", when not otherwise limited, means the latest edition of the official United States pharmacopeia, and its supplement.
5. "Homeopathic pharmacopeia" means the official homeopathic pharmacopeia of the United States, and its supplement.
6. "Official compendium" means the official United States pharmacopeia, official homeopathic pharmacopeia of the United States, official national formulary, or their supplements.
7. "Drugs" means:
   1. Articles recognized in the official United States pharmacopeia, official homeopathic pharmacopeia of the United States, or official national formulary.
   2. Articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or animals.
   3. Articles (other than food) intended to affect the structure or any function of the body of man or animals.
   4. Articles intended for use as a component of any article specified in paragraphs a, b, or c; but does not include devices or their components, parts or accessories.
8. "Cosmetics" means:
   1. Articles intended to be rubbed, poured, sprinkled or sprayed on, introduced into or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance.
   2. Articles intended for use as a component of any such articles; except that the term shall not include soap.
9. "Poison", where not otherwise limited, means any drug, chemical or preparation likely to be destructive to adult human life in quantity of sixty grains or less.
10. "Label" means a display of written, printed or pictorial matter upon the immediate container of any drug, device or cosmetic. Any requirement made by or under authority of this article, that any word, statement, or other information appear on the label shall not be considered to be complied with unless such word, statement or other information also appears on the outside container or wrapper, if there be any, of the retail package of such drug, device or cosmetic or is easily legible through the outside container or wrapper.
11. "Immediate container" does not include package liners.
12. "Labeling" means all labels and other written, printed or pictorial matter:
    1. Upon any drug, device or cosmetic or any of its containers or wrappers, or
    2. Accompanying such drug, device or cosmetic.
13. "Misbranding". If a drug, device or cosmetic is alleged to be misbranded because the labeling is misleading, or if an advertisement is alleged to be false because it is misleading then in determining whether the labeling or advertisement is misleading there shall be taken into account (among other things) not only representations made or suggested by statement, word, design, device, sound or any combination thereof, but also the extent to which the labeling fails to reveal facts material in the light of such representations or material with respect to consequences which may result from the use of the drug, device, or cosmetic to which the labeling or advertising relates under the conditions of use prescribed in the labeling or advertising thereof or under such conditions of use as are customary or usual. No drug, device or cosmetic which is subject to, and complies with regulations promulgated under the provisions of the federal food, drug, and cosmetic act, relating to adulteration and misbranding shall be deemed to be adulterated or misbranded in violation of the provisions of this article because of its failure to comply with the board's regulations, or the rules of the state board of pharmacy, insofar as the regulations are in conflict with regulations relating to adulteration and misbranding under the federal food, drug and cosmetic act.
14. "Antiseptic". The representation of a drug, device or cosmetic in its labeling, as 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.
15. "New drug" means:
    1. Any drug not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended or suggested by the drug's labeling, except that such a drug not so recognized shall not be deemed to be a "new drug" if at any time prior to September first, nineteen hundred thirty-nine it was subject to the former federal food and drug act of June thirtieth, nineteen hundred six, as amended, and if at such time its labeling contained the same representations concerning the conditions of its use;
    2. Any drug, the composition of which is such that the drug, as a result of investigations to determine its safety and effectiveness for use under such conditions, has become recognized, but which has not otherwise than in such investigations been used to a material extent or for a material time under such conditions.
16. "Device" means instruments, apparatus, and contrivances, including their components, parts and accessories, intended: a. For use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or animals; or b. To affect the structure or any function of the body of man or animals.
17. The term "Federal Food, Drug and Cosmetic Act" means the Federal Food, Drug, and Cosmetic Act of the United States of America, approved June twenty-fifth, nineteen hundred thirty-eight, officially cited as public document number seven hundred seventeen-seventy-fifth congress (chapter six hundred seventy-five--third session), and all its amendments now or hereafter enacted.
18. "Wholesaler" means a person who bottles, packs or purchases drugs, devices or cosmetics for the purpose of selling or reselling to pharmacies or to other channels as provided in this article.
19. "Advertisement" means all representations disseminated in any manner or by any means, other than by labeling, for the purpose of inducing, or which are likely to induce, directly or indirectly, the purchase of drugs, devices or cosmetics.
20. "Controlled substance" means any drug defined as a controlled substance by article thirty-three of the public health law.
21. "Manufacturer" means a person who compounds, mixes, prepares, produces, and bottles or packs drugs, cosmetics or devices for the purpose of distributing or selling to pharmacies or to other channels of distribution.
22. *"Administer", for the purpose of section sixty-eight hundred one of this article, means:
    1. the direct application of an immunizing agent to adults, whether by injection, ingestion, inhalation or any other means, pursuant to a patient specific order or non-patient specific regimen prescribed or ordered by a physician or certified nurse practitioner, for: immunizations to prevent influenza, pneumococcal, acute herpes zoster, hepatitis A, hepatitis B, human papillomavirus, measles, mumps, rubella, varicella, COVID-19, meningococcal, tetanus, diphtheria or pertussis disease and medications required for emergency treatment of anaphylaxis; and other immunizations recommended by the advisory committee on immunization practices of the centers for disease control and prevention for patients eighteen years of age or older if the commissioner of health in consultation with the commissioner determines that an immunization: (i)(A) may be safely administered by a licensed pharmacist within their lawful scope of practice; and (B) is needed to prevent the transmission of a reportable communicable disease that is prevalent in New York state; or (ii) is a recommended immunization for such patients who: (A) meet age requirements, (B) lack documentation of such immunization, (C) lack evidence of past infection, or (D) have an additional risk factor or another indication as recommended by the advisory committee on immunization practices of the centers for disease control and prevention. If the commissioner of health determines that there is an outbreak of disease, or that there is the imminent threat of an outbreak of disease, then the commissioner of health may issue a non-patient specific regimen applicable statewide.
    2. the direct application of an immunizing agent to children between the ages of two and eighteen years of age, whether by injection, ingestion, inhalation or any other means, pursuant to a patient specific order or non-patient specific regimen prescribed or ordered by a physician or certified nurse practitioner, for immunization to prevent influenza and medications required for emergency treatment of anaphylaxis resulting from such immunization. If the commissioner of health determines that there is an outbreak of influenza, or that there is the imminent threat of an outbreak of influenza, then the commissioner of health may issue a non-patient specific regimen applicable statewide.
    * NB Effective until December 28, 2023

22. * "Administer", for the purpose of section sixty-eight hundred one of this article, means:
    1. 1. the direct application of an immunizing agent to adults, whether by injection, ingestion, inhalation or any other means, pursuant to a patient specific order or non-patient specific regimen prescribed or ordered by a physician or certified nurse practitioner, for: immunizations to prevent influenza, pneumococcal, acute herpes zoster, hepatitis A, hepatitis B, human papillomavirus, measles, mumps, rubella, varicella, COVID-19, meningococcal, tetanus, diphtheria or pertussis disease and medications required for emergency treatment of anaphylaxis; and other immunizations recommended by the advisory committee on immunization practices of the centers for disease control and prevention for patients eighteen years of age or older if the commissioner of health in consultation with the commissioner determines that an immunization: (i)(A) may be safely administered by a licensed pharmacist within their lawful scope of practice; and (B) is needed to prevent the transmission of a reportable communicable disease that is prevalent in New York state; or (ii) is a recommended immunization for such patients who: (A) meet age requirements, (B) lack documentation of such immunization, (C) lack evidence of past infection, or (D) have an additional risk factor or another indication as recommended by the advisory committee on immunization practices of the centers for disease control and prevention. If the commissioner of health determines that there is an outbreak of disease, or that there is the imminent threat of an outbreak of disease, then the commissioner of health may issue a non-patient specific regimen applicable statewide.
       2. the direct application of an immunizing agent to children between the ages of two and eighteen years of age, whether by injection, ingestion, inhalation or any other means, pursuant to a patient specific order or non-patient specific regimen prescribed or ordered by a physician or certified nurse practitioner, for immunization to prevent influenza and medications required for emergency treatment of anaphylaxis resulting from such immunization. If the commissioner of health determines that there is an outbreak of influenza, or that there is the imminent threat of an outbreak of influenza, then the commissioner of health may issue a non-patient specific regimen applicable statewide.
    2. The injection of medications into the deltoid muscle for the treatment of mental health and substance use disorder, as prescribed or ordered by a licensed prescriber, acting within the scope of their practice in this state and in accordance with regulations promulgated by the commissioner and the department of health in consultation with any other state agencies as necessary, but not be limited to, providing that:
       1. Such administration is conducted pursuant to a valid prescription or order that authorizes a pharmacist to administer medications for the treatment of mental health and substance use disorder and the pharmacist notifies the licensed prescriber that the administration is complete. Administration in a pharmacy may not commence until after the patient has received the initial injection and is considered eligible for maintenance treatment by the licensed prescriber.
       2. Such prescription may be subject to reassessment at appropriate intervals, as determined by the licensed prescriber.
       3. Such activity is conducted in accordance with regulations, promulgated or adopted by the commissioner and the department of health, in consultation with any other state agencies, as necessary, which shall include requirements for the following:
          1. Training accredited by the accreditation council for pharmacy education, that may include educational experiences obtained through pharmacy school curricula, or a similar health authority or professional body appropriate for the medications being administered and their respective patient populations. Such training must be satisfactory to the commissioner and the department of health, in consultation with the board of pharmacy and any other state agencies, as necessary, which shall include, but not be limited to learning modules on techniques for administration by injections, indications, precautions, and contraindications in the use of agent or agents; record keeping and information; and handling emergencies, including anaphylaxis, needle-sticks and cardiopulmonary resuscitation.
          2. Maintaining continued competency regarding the populations served and medications administered.
          3. Pre-administration patient consent and education regarding common side effects, drug interactions, injection site reactions and other information routinely provided to patients upon dispensing. If a patient is unable to provide consent, the pharmacist must obtain consent from a person legally responsible when the recipient is incapable of consenting.
          4. When administering an injection in a pharmacy, the pharmacist shall provide an area for the injection that provides for the patient's privacy.
          5. Record keeping and reporting of such administration by electronic transmission or facsimile to the patient's licensed prescriber, and, to the extent practicable, make himself or herself available to discuss the outcome of such injection, including any adverse reactions, with the licensed prescriber acting within their scope of practice.
    * NB Effective December 28, 2023.
23. "Electronic prescription" means a prescription created, recorded, or stored by electronic means; issued with an electronic signature; and transmitted by electronic means, in accordance with regulations of the commissioner and applicable regulations of the commissioner of health and federal regulations; provided, however, that an original hard copy prescription that is created electronically or otherwise may be transmitted from the prescriber to the pharmacist by facsimile and must be manually signed. "Electronic" means of or relating to technology having electrical, digital, magnetic, wireless, optical, electromagnetic, or similar capabilities. "Electronic signature" means an electronic sound, symbol, or process, attached to or logically associated with an electronic prescription and executed or adopted by a person with the intent to sign the prescription, in accordance with regulations of the commissioner and applicable regulations of the commissioner of health and federal regulations.
24. "Compounding" means the combining, admixing, mixing, diluting, pooling, reconstituting, or otherwise altering of a drug or bulk drug substance to create a drug with respect to an outsourcing facility under section 503B of the Federal Food, Drug and Cosmetic Act and further defined in this section. 25. "Outsourcing facility" means a facility that: (a) is engaged in the compounding of sterile drugs; (b) is currently registered as an outsourcing facility with the Secretary of Health and Human Services; and (c) complies with all applicable requirements of federal and state law, including the Federal Food, Drug and Cosmetic Act.
25. "Sterile drug" means a drug that is intended for parenteral administration, an ophthalmic or oral inhalation drug in aqueous format, or a drug that is required to be sterile under federal or state law.
26. "Biological product" means a biological product as defined in subsection (i) of section 351 of the Public Health Service Act, 42 U.S.C. Section 262(i).
27. "Interchangeable biological product" means a biological product licensed by the United States Food and Drug Administration pursuant to 42 U.S.C. Section 262(k)(4) as set forth in the latest edition or supplement of the United States Food and Drug Administration Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations, sometimes referred to as the "Purple Book," or a biological product determined by the United States Food and Drug Administration to be therapeutically equivalent as set forth in the latest edition or supplement of the United States Food and Drug Administration Approved Drug Products with Therapeutic Equivalence Evaluations, sometimes referred to as the "Orange Book."

1. The following schedules shall remain in force until revised by the board and approved by the department.

   Schedule A. Arsenic, atropine, corrosive sublimate, potassium cyanide, chloral hydrate, hydrocyanic acid, strychnine and all other poisonous vegetable alkaloids and their salts and oil of bitter almond containing hydrocyanic acid.

   Schedule B. Aconite, belladonna, cantharides, colchicum, conium cotton root, digitalis, ergot, hellebore, henbane, phytolacca, strophanthus, oil of savin, oil of tansy, veratrum viride and their pharmaceutical preparations, arsenical solutions, carbolic acid, chloroform, creosote, croton oil, white precipitate, methyl or wood alcohol, mineral acids, oxalic acid, paris green, salts of lead, salts of zinc, or any drug, chemical or preparation which is liable to be destructive to adult human life in quantities of sixty grains or less.

2. It shall be unlawful for any person to sell at retail or to furnish any of the poisons of schedules A and B without affixing or causing to be affixed to the bottle, box, vessel or package, a label with the name of the article and the word "poison" distinctly shown and with the name and place of business of the seller all printed in red ink together with the name of such poisons printed or written thereupon in plain, legible characters.
3. Manufacturers and wholesale dealers in drugs, medicines, pharmaceutical preparations, chemicals or poisons shall affix or cause to be affixed to every bottle, box, parcel or outer inclosure of any original package containing any of the articles of schedule A a suitable label or brand in red ink with the word "poison" upon it.
4. Every person who disposes of or sells at retail or furnishes any poisons included in schedule A shall before delivering the same enter in a book kept for that purpose the date of sale, the name and address of the purchaser, the name and the quantity of the poison, the purpose for which it is purchased and the name of the dispenser. The poison register must be always open for inspection by the proper authorities and must be preserved for at least five years after the last entry. Such person shall not deliver any of the poisons of schedule A or schedule B until he has satisfied himself that the purchaser is aware of its poisonous character and that the poison is to be used for a legitimate purpose. The provisions of this paragraph do not apply to the dispensing of drugs or poisons on a doctor's prescription.
5. The board may add to or may delete from any of the schedules from time to time as such action becomes necessary for the protection of the public.

Only a person licensed or otherwise authorized under this article shall practice pharmacy or use the title "pharmacist" or any derivative.

The secretary is authorized to conduct examinations and investigations for the purposes of this article through officers and employees of the United States, or through any health, food, or drug officer or employee of any city, county or other political subdivision of this state, duly commissioned by the secretary as an officer of the board.

A state board of pharmacy shall be appointed by the regents on recommendation of the commissioner for the purpose of assisting the regents and the department on matters of professional licensing and professional conduct in accordance with section sixty-five hundred eight of this title. The board shall be composed of not less than nine pharmacists licensed in this state for at least five years. An executive secretary to the board shall be appointed by the regents on recommendation of the commissioner and shall be a pharmacist licensed in this state for at least five years. The board shall have power:

1. To regulate the practice of pharmacy and the employment of interns and employees in pharmacies,
2. To regulate and control the sale, distribution, character and standard of drugs, poisons, cosmetics, devices and new drugs,
3. To employ inspectors and chemists,
4. To prevent the sale or distribution of such drugs, poisons, cosmetics, devices and new drugs as do not conform to the provisions of this article or of the public health law,
5. To investigate alleged violations of the provisions of this article, through its own investigative personnel or those of other agencies, to conduct hearings, to levy money penalties, and to bring alleged violations to the notice of the attorney general, and
6. To issue limited permits or registrations.

NB Effective until April 25, 2021

For purposes of enforcement of this article, officers duly designated by the secretary are authorized:

1. to enter, at reasonable times, any factory, warehouse or establishment in which drugs, devices or cosmetics are manufactured, processed, packed, or held, for introduction into commerce or are held after such introduction, or to enter any vehicle being used to transport or hold such drugs, devices or cosmetics in commerce; and
2. to inspect, at reasonable times, such factory, warehouse, establishment or vehicle and all pertinent equipment, finished and unfinished materials, containers, and labeling therein.

1. To qualify for a pharmacist's license, an applicant shall fulfill the following requirements:
   1. Application: file an application with the department;
   2. Education: have received an education, including a bachelor's or equivalent degree in pharmacy, in accordance with the commissioner's Regulations;
   3. Experience: have experience satisfactory to the board and in accordance with the commissioner's regulations;
   4. Examination: pass an examination satisfactory to the board and in accordance with the commissioner's regulations;
   5. Age: be at least twenty-one years of age;
   6. Citizenship or immigration status: be a United States citizen or an alien lawfully admitted for permanent residence in the United States;
   7. Character: be of good moral character as determined by the department; and
   8. Fees: pay a fee of one hundred seventy-five dollars to the department for admission to a department conducted examination and for an initial license, a fee of eighty-five dollars for each re-examination, a fee of one hundred fifteen dollars for an initial license for persons not requiring admission to a department conducted examination, and a fee of one hundred fifty-five dollars for each triennial registration period.
2. On or before April first, nineteen hundred seventy-two, any person who holds a valid license as "druggist" in this state shall make application and on the payment of fees specified in this title be licensed by the department as a pharmacist. Such person shall have all of the rights, privileges, duties and responsibilities of a pharmacist.

In addition to the remedies hereinafter provided, the secretary is hereby authorized to apply to the court of the proper venue for an injunction to restrain any person from (a) introducing or causing to be introduced into commerce any adulterated or misbranded drug, device or cosmetic; or (b) from introducing or causing to be introduced in commerce any new drug which does not comply with the provisions of this article; or (c) from disseminating or causing to be disseminated a false advertisment, without being compelled to allege or prove that an adequate remedy at law does not exist.

1. The department may issue a limited permit for employment as a "pharmacy intern" to:
   1. A student enrolled in the last two years of a registered program in pharmacy, or
   2. A graduate of a program in pharmacy which meets standards established by the commissioner's regulations who is engaged in meeting the experience requirements or whose application for initial licensure is pending with the department.
2. A pharmacy intern may, as determined by the commissioner's regulations, practice as a pharmacist under the immediate personal supervision of a licensed pharmacist.
3. A limited permit issued to a pharmacy intern shall have an expiration date of five years from the date of issue. Limited permits may be renewed once for a period not to exceed two years.
4. Fees. The fee for each limited permit issued to a pharmacy intern shall be seventy dollars.

1. In an action or proceeding, civil or criminal, against a person for violating such provisions of this article which relate to the possession of, compounding, retailing or dispensing of misbranded, substituted or imitated drugs, poisons or cosmetics, when it shall be necessary that an analysis be made for the purpose of establishing the quality of such drug, poison or cosmetic so as to determine the fact of misbranding, substituting or imitating, then it shall be required to prove at the trial or hearing of such action or proceeding, that the person, taking the same for analysis separated it into two representative parts, hermetically or otherwise effectively and completely sealed, delivered one such sealed part to the seller, manufacturer, wholesaler, pharmacist, druggist or storekeeper from whose premises such sample was taken and delivered the other part so sealed to the chemist designated by the state board of pharmacy; and the facts herein required to be proven shall be alleged in the complaint or information by which such action or proceeding was begun. The rules of the board shall be proven prima facie by the certificate of the secretary.
2. Any person accused of violation of any of the provisions of this article relating to adulterating, misbranding, substitution or imitation shall not be prosecuted or convicted or suffer any of the penalties, fines or forfeitures for such violation, if he establishes upon the hearing or trial that the drug, device or cosmetic alleged to be adulterated, misbranded, substituted or imitated was purchased by him under a written guaranty of the manufacturer or seller to the effect that said drug, device or cosmetic was not adulterated or misbranded, within the meaning of this article and proves that he has not adulterated, misbranded, substituted or imitated the same, provided the seller has taken due precaution to maintain the standard set for the drug, device or cosmetic. A guaranty, in order to be a defense to a prosecution or to prevent conviction or to afford protection, must state that the drug, device or cosmetic to which it refers is not adulterated, misbranded, substituted or imitated within the meaning of the provisions of this article and must state also the full name and place of business of the manufacturer, wholesaler, jobber or other person from whom the drug, device or cosmetic was purchased, and the date of purchase. The act, omission or failure of any officer, agent or other employee acting for or employed by any person within the scope of his authority or employment shall in every case be the act, omission or failure of such person as well as that of the officer, agent or other employee, and such person shall be equally liable for violations of this article by a partnership, association or corporation, and every member of the partnership or association and the directors and general officers of the corporation and the general manager of the partnership, association or corporation shall be individually liable and any action, prosecution or proceeding authorized by this article may be brought against any or all of such persons. When any prosecution under this article is made on the complaint of the board, any fines collected shall be paid into the state treasury as provided by this article.
3. No publisher, radio-broadcast licensee, advertising agency, or agency or medium for the dissemination of advertising, except the manufacturer, packer, distributor, or seller of the commodity to which the false advertisement relates, shall be subject to the penalties provided by this article by reason of the dissemination by him of any false advertisement, unless he has refused, on the request of the secretary, to furnish the secretary the name and post-office address of the manufacturer, packer, distributor, seller or advertising agency, who caused him to disseminate such advertisement.

1. This article shall not be construed to affect or prevent:
   1. Unlicensed assistants from being employed in licensed pharmacies for purposes other than the practice of pharmacy;
   2. Any physician, dentist, veterinarian or other licensed health care provider legally authorized to prescribe drugs under this title who is not the owner of a pharmacy, or registered store, or who is not in the employ of such owner, from supplying his patients with such drugs as the physician, dentist, veterinarian or other licensed health care provider legally authorized to prescribe drugs under this title deems proper in connection with his practice, provided, however, that all such drugs shall be dispensed in a container labeled with the name and address of the dispenser and patient, directions for use, and date of delivery, and in addition, such drug shall bear a label containing the proprietary or brand name of the drug and, if applicable, the strength of the contents, unless the person issuing the prescription specifically states on the prescription in his own handwriting, that the name of the drug and the strength thereof should not appear on the label; provided further that if such drugs are controlled substances, they shall be dispensed pursuant to the requirements of article thirty-three of the public health law;
   3. Any merchant from selling proprietary medicines, except those which are poisonous, deleterious or habit forming, or materials and devices specifically exempted by regulations of the department or by the public health law;
   4. Any personnel in an institution of higher learning from using prescription-required drugs on the premises for authorized research, experiments or instruction, in accordance with the department's regulations and, if such drugs are controlled substances, in accordance with title III of article thirty-three of the public health law; or
   5. The necessary and ordinary activities of manufacturers and wholesalers, subject to the provisions of article thirty-three of the public health law.
2. 1. Notwithstanding the provisions of paragraph b of subdivision one of this section, no prescriber who is not the owner of a pharmacy, or registered store, or who is not in the employ of such owner, may dispense more than a seventy-two hour supply of drugs, except for:
      1. persons practicing in hospitals as defined in section twenty-eight hundred one of the public health law;
      2. the dispensing of drugs at no charge to their patients;
      3. persons whose practices are situated ten miles or more from a registered pharmacy;
      4. the dispensing of drugs in a clinic, infirmary or health service that is operated by or affiliated with a post-secondary institution;
      5. persons licensed pursuant to article one hundred thirty-five of this title;
      6. the dispensing of drugs in a medical emergency as defined in subdivision six of section sixty-eight hundred ten of this article;
      7. the dispensing of drugs that are diluted, reconstituted or compounded by a prescriber;
      8. the dispensing of allergenic extracts; or
      9. the dispensing of drugs pursuant to an oncological or AIDS protocol.
   2. The commissioner, in consultation with the commissioner of health, may promulgate regulations to implement this subdivision and may, by regulation, establish additional renewable exemptions for a period not to exceed one year from the provisions of paragraph a of this subdivision.
3. A pharmacist may dispense drugs and devices to a registered professional nurse, and a registered professional nurse may possess and administer, drugs and devices, pursuant to a non-patient specific regimen prescribed or ordered by a licensed physician or certified nurse practitioner, pursuant to regulations promulgated by the commissioner and the public health law.

1. Every pharmacy shall compile a drug retail price list, which shall contain the names of the drugs on the list provided by the board, the pharmacy's corresponding retail prices for each drug. Every pharmacy shall update its drug retail list at least weekly and provide the time and date that the list was updated. Every pharmacy shall provide the drug retail price list to any person upon request.
2.  
   1. The list provided by the board shall be prepared at least annually by the board and distributed to each pharmacy in the state. The list shall be a compendium of the one hundred fifty most frequently prescribed drugs together with their usual dosages for which a prescription is required by the provisions of the "Federal Food, Drug, and Cosmetic Act" (21 U.S.C. 301, et seq.; 52 Stat. 1040, et seq.), as amended, or by the commissioner of health. The board shall make the compendium list available to each pharmacy free of charge, both in printed form and in an electronic form that can be used to produce the pharmacy's drug retail list. The board shall provide the compendium list to the department of health.
   2. The drug retail price list shall contain an advisory statement by the department alerting consumers to the need to tell their health care practitioner and pharmacist about all the medications they may be taking and to ask them how to avoid harmful interactions between drugs, if any. A pharmacy may include on its drug retail price list a statement: (a) concerning discounts from its listed retail prices that may be available to consumers and (b) any limitations that the pharmacy may have as to what group or groups of customers it serves.
3. The pharmacy's corresponding retail price means the actual price to be paid by a retail purchaser to the pharmacy for any listed drug at the listed dosage. However, upon implementation of the prescription drug retail price list database by the department of health under section two hundred seventy-six-a of the public health law, the pharmacy's corresponding retail price shall mean the price sent to it by the department of health under that section.
4. Pharmacies shall have a sign notifying people of the availability of the drug retail price list and the availability of the department of health prescription drug retail price list database and the web address of that database, conspicuously posted at or adjacent to the place in the pharmacy where prescriptions are presented for compounding and dispensing, in the waiting area for customers, or in the area where prescribed drugs are delivered.
5. Nothing contained herein shall prevent a pharmacy from changing and charging the current retail price at any time, provided that the listed price is updated at least weekly to reflect the new retail price.
6. The commissioner shall make regulations necessary to implement this section, including how this section is applied to mail-order and internet pharmacies.

1. No person, firm, corporation or association shall possess drugs, prescriptions or poisons for the purpose of compounding, dispensing, retailing, wholesaling, or manufacturing, or shall offer drugs, prescriptions or poisons for sale at retail or wholesale unless registered by the department as a pharmacy, wholesaler, manufacturer or outsourcing facility.
2. Pharmacies.
   1. Obtaining a registration. A pharmacy shall be registered as follows:
      1. The application shall be made on a form prescribed by the department.
      2. The application shall be accompanied by a fee of three hundred forty-five dollars.
      3. To secure and retain a registration, a pharmacy must be equipped with facilities, apparatus, utensils and stocks of drugs and medicines sufficient to permit the prompt and efficient compounding and dispensing of prescriptions, as prescribed by regulation.
   2. Renewal of registration. All pharmacy registrations shall be renewed on dates set by the department. The triennial registration fee shall be two hundred sixty dollars or a pro rated portion thereof as determined by the department At the time of renewal, the owner of every pharmacy shall report under oath to the department any facts required by the board of pharmacy.
   3. Display of registration. The registration shall be conspicuously displayed at all times in the pharmacy. The names of the owner or owners of a pharmacy shall be conspicuously displayed upon the exterior of such establishment. The names so displayed shall be presumptive evidence of ownership of such pharmacy by such person or persons. In the event that the owner of a licensed pharmacy is not a licensed pharmacist, the pharmacy registration issued shall also bear the name of the licensed pharmacist having personal supervision of the pharmacy. In the event that such licensed pharmacist shall no longer have personal supervision of the pharmacy, the owner shall notify the department of such fact and of the name of the licensed pharmacist replacing the pharmacist named on the license and shall apply for an amended registration showing the change. The amended registration must be attached to the original registration and displayed in the same manner. Both the owner and the supervising pharmacist shall be responsible for carrying out the provisions of this article.
   4. Change of location. In the event that the location of a pharmacy shall be changed, the owner shall apply to the department for inspection of the new location and endorsement of the registration for the new location. The fee for inspection and endorsement shall be fifty dollars, unless it appears to the satisfaction of the department that the change in location is of temporary nature due to fire, flood or other disaster.
   5. Conduct of a pharmacy. Every owner of a pharmacy is responsible for the strength, quality, purity and the labeling thereof of all drugs, toxic substances, devices and cosmetics, dispensed or sold, subject to the guaranty provisions of this article and the public health law. Every owner of a pharmacy or every pharmacist in charge of a pharmacy shall be responsible for the proper conduct of this pharmacy. Every pharmacy shall be under the immediate supervision and management of a licensed pharmacist at all hours when open. No pharmacist shall have personal supervision of more than one pharmacy at the same time.
   6. A pharmacy as a department. When a pharmacy is operated as a department of a larger commercial establishment, the area comprising the pharmacy shall be physically separated from the rest of the establishment, so that access to the pharmacy and drugs is not available when a pharmacist is not on duty. Identification of the area within the pharmacy by use of the words "drugs", "medicines", "drug store", or "pharmacy" or similar terms shall be restricted to the area licensed by the department as a pharmacy.
   7. Limited pharmacy registration.
      1. When, in the opinion of the department, a high standard of patient safety, consistent with good patient care, can be provided by the registering of a pharmacy within a hospital, nursing home or extended care facility which does not meet all of the requirements for registration as a pharmacy, the department may waive any requirements pertaining to full-time operation by a licensed pharmacist, minimum equipment, minimum space and waiting area, provided that when the waiver of any of the above requirements is granted by the board, the pharmaceutical services to be rendered by the pharmacy shall be limited to furnishing drugs to patients registered for treatment by the hospital, and to in-patients for treatment by the nursing home or extended care facility.
      2. When in the opinion of the department, a high standard of patient safety, consistent with good patient care, can be provided by the registering of a pharmacy within a facility distributing dialysis solutions for patients suffering from end stage renal disease and where the pharmaceutical services to be rendered by the pharmacy shall be limited to furnishing dialysis solutions to patients for whom such has been prescribed by a duly authorized prescriber, the department may waive certain requirements, including, but not limited to, full-time operation by a licensed pharmacist, minimum equipment, and minimum space and waiting area. Such solutions shall only be dispensed by employees who have completed an approved training program and who have demonstrated proficiency to perform the task or tasks of assemblying, labeling or delivering a patient order and who work under the general supervision of a licensed pharmacist who shall be responsible for the distribution, record keeping, labeling and delivery of all dialysis solutions dispensed by the distributor as required by the department.
      3. The department shall promulgate such rules or regulations consistent with this paragraph as are necessary to ensure the safe distribution of such dialysis solution, including establishment registration and proper record keeping, storage, and labeling.
      4. The initial registration fee and renewal fee for a limited pharmacy shall be three hundred forty-five dollars for each triennial registration period.
   8. Applicant registration. An applicant for registration as a pharmacy shall be of good moral character, as determined by the department. In the case of a corporate applicant, the requirement shall extend to all officers and directors and to stockholders having a ten percent or greater interest in the corporation.
3. [Repealed]
4. Wholesaler's or manufacturer's registration.
   1. Obtaining a registration. A wholesaler or manufacturer shall be registered as follows:
      1. The application shall be made on a form prescribed by the department.
      2. The application shall be accompanied by a fee of eight hundred twenty-five dollars.
   2. Renewal of registration. All wholesalers' and manufacturers' registrations shall be renewed on dates set by the department. The triennial registration fee shall be five hundred twenty dollars or a pro rated portion thereof as determined by the department
   3. Display of registration. The registration shall be displayed conspicuously at all times in the place of business.
   4. Change of location. In the event that the location of such place of business shall be changed, the owner shall apply to the department for inspection of the new location and endorsement of the registration for the new location. The fee for inspection and endorsement shall be one hundred seventy dollars, unless it appears to the satisfaction of the department that the change in location is of a temporary nature due to fire, flood or other disaster.
5. Outsourcing facility's registration.
   1. Obtaining a registration. An outsourcing facility shall be registered as follows:
      1. An application for initial registration or renewal of registration shall be made on a form prescribed by the department.
      2. An application for initial registration shall be accompanied by a fee of eight hundred twenty-five dollars.
   2. Renewal of registration. All outsourcing facilities' registrations shall be renewed on a date set by the department. The triennial registration fee shall be five hundred twenty dollars or a pro rated portion thereof as determined by the department.
   3. Display of registration. The registration shall be displayed conspicuously in the place of business.
   4. Change of location. In the event that the location of such place of business shall be changed, the owner shall apply to the department for inspection of the new location and endorsement of the registration for the new location. The fee for inspection and endorsement shall be one hundred seventy-five dollars, unless it appears to the satisfaction of the department that the change in location is of a temporary nature due to fire, flood or other disaster.
   5. Report. Upon initially registering as an outsourcing facility and every six months thereafter, each outsourcing facility shall submit to the executive secretary of the state board of pharmacy a report:
      1. identifying the drugs compounded by such outsourcing facility during the previous 6-month period; and
      2. with respect to each drug identified under subparagraph one of this paragraph, providing the active ingredient; the source of such active ingredient; the National Drug Code number of the source drug or bulk active ingredient, if available; the strength of the active ingredient per unit; the dosage form and route of administration; the package description; the number of individual units produced; and the National Drug Code number of the final product, if assigned.
   6. Conduct of outsourcing facility. Every owner of an outsourcing facility is responsible for the strength, quality, purity and labeling thereof of all compounded drugs, subject to the guaranty provisions of this article and the public health law. Every outsourcing facility shall be under the immediate supervision and management of a pharmacist licensed to practice in New York state.
   7. Applicant for registration. An applicant for registration of an outsourcing facility shall be of good moral character, as determined by the department. In the case of a corporate applicant, the requirement shall extend to all officers and directors and stakeholders having a ten percent or greater interest in the corporation.
6. Inspection. The state board of pharmacy and the department of education, and their employees designated by the commissioner, shall have the right to enter any pharmacy, wholesaler, manufacturer, outsourcing facility or vehicle and to inspect, at reasonable times, such factory, warehouse, establishment or vehicle and all records required by this article, pertinent equipment, finished and unfinished materials, containers, and labels.
7. Penalties. A pharmacy, wholesaler, manufacturer or outsourcing facility registered under this section shall be under the supervision of the board of regents and shall be subject to disciplinary proceedings and penalties in accordance with article one hundred thirty of this chapter in the same manner and to the same extent as individuals and professional service corporations with respect to their licenses and registrations, provided that failure to comply with the requirements of this section shall constitute professional misconduct.
8. Sale of drugs at auction. No controlled substance or substances and no poisonous or deleterious drugs or drugs in bulk or in opened containers shall be sold at auction unless the place where such drugs are sold at auction shall have been registered by the board, and unless such sale shall be under the personal supervision of a licensed pharmacist. Drugs in open containers shall not be sold at auction unless the seller shall have in his possession a certificate of the board showing that such drugs have been inspected and meet the requirements of this article. In the event that the drug so sold is one as to which this article or any federal statute or any regulation adopted pursuant to this article or an applicable federal statute require that the expiration date be stated on each package, such drug may not be sold at auction after such expiration date or when such expiration date will occur within a period of thirty days or less from the date of sale.

1. Where an insured's copayment for a drug exceeds the corresponding retail price for the same drug on the pharmacy's drug retail price list, the pharmacist shall notify the insured of this occurrence and charge no greater than the pharmacy's corresponding retail price.
2. Where the drug being purchased is not on the drug retail price list, and the copayment for the drug exceeds the pharmacy's usual and customary price for that drug, the pharmacist shall notify the insured of this occurrence and charge the lesser of the insured's copayment and the pharmacy's usual and customary price for that drug.

Every pharmacist on duty shall be identified by a badge designed by the state board of pharmacy, which shall contain his name and title.

1.  
   1. Each licensed pharmacist required under article one hundred thirty of this chapter to register triennially with the department to practice in the state shall comply with provisions of the mandatory continuing education requirements prescribed in subdivision two of this section except as set forth in paragraphs (b) and (c) of this subdivision. Pharmacists who do not satisfy the mandatory continuing education requirements shall not practice until they have met such requirements, and they have been issued a registration certificate, except that a pharmacist may practice without having met such requirements if he or she is issued a conditional registration certificate pursuant to subdivision three of this section.
   2. In accord with the intent of this section, adjustment to the mandatory continuing education requirement may be granted by the department for reasons of health certified by an appropriate health care professional, for extended active duty with the armed forces of the United States, or for other good cause acceptable to the department which may prevent compliance.
   3. A licensed pharmacist not engaged in practice as determined by the department, shall be exempt from the mandatory continuing education requirement upon the filing of a statement with the department declaring such status. Any licensee who returns to the practice of pharmacy during the triennial registration period shall notify the department prior to reentering the profession and shall meet such mandatory education requirements as shall be prescribed by regulations of the commissioner.
2. * During each triennial registration period an applicant for registration shall complete a minimum of forty-five hours of acceptable formal continuing education, as specified in subdivision four of this section, provided that no more than twenty-two hours of such continuing education shall consist of self-study courses. Any pharmacist participating in collaborative drug therapy management pursuant to section six thousand eight hundred one-a of this article shall complete at least five hours of acceptable formal continuing education in the area or areas of practice generally related to any collaborative drug therapy management protocols to which the pharmacist may be subject. Any pharmacist whose first registration date following the effective date of this section occurs less than three years from such effective date, but on or after January first, nineteen hundred ninety-eight, shall complete continuing education hours on a prorated basis at the rate of one and one-quarter hours per month for the period beginning January first, nineteen hundred ninety-seven up to the first registration date thereafter. A licensee who has not satisfied the mandatory continuing education requirements shall not be issued a triennial registration certificate by the department and shall not practice unless and until a conditional registration certificate is issued as provided for in subdivision three of this section. Continuing education hours taken during one triennium may not be transferred to a subsequent triennium.

   *NB Effective until September 14, 2015

2. *During each triennial registration period an applicant for registration shall complete a minimum of forty-five hours of acceptable formal continuing education, as specified in subdivision four of this section, provided that no more than twenty-two hours of such continuing education shall consist of self-study courses. Any pharmacist whose first registration date following the effective date of this section occurs less than three years from such effective date, but on or after January first, nineteen hundred ninety-eight, shall complete continuing education hours on a prorated basis at the rate of one and one-quarter hours per month for the period beginning January first, nineteen hundred ninety-seven up to the first registration date thereafter. A licensee who has not satisfied the mandatory continuing education requirements shall not be issued a triennial registration certificate by the department and shall not practice unless and until a conditional registration certificate is issued as provided for in subdivision three of this section. Continuing education hours taken during one triennium may not be transferred to a subsequent triennium.

   *NB Effective September 14, 2018

3. The department, in its discretion, may issue a conditional registration to a licensee who fails to meet the continuing education requirements established in subdivision two of this section but who agrees to make up any deficiencies and complete any additional education which the department may require. The fee for such a conditional registration shall be the same as, and in addition to, the fee for the triennial registration. The duration of such conditional registration shall be determined by the department but shall not exceed one year. Any licensee who is notified of the denial of registration for failure to submit evidence, satisfactory to the department, of required continuing education and who practices pharmacy without such registration, may be subject to disciplinary proceedings pursuant to section sixty-five hundred ten of this chapter.
4. As used in subdivision two of this section, "acceptable formal continuing education" shall mean formal courses of learning which contribute to professional practice in pharmacy and which meet the standards prescribed by regulations of the commissioner. The department may, in its discretion and as needed to contribute to the health and welfare of the public, require the completion of continuing education courses in specific subjects. To fulfill this mandatory continuing education requirement, courses must be taken from a sponsor approved by the department, pursuant to the regulations of the commissioner.
5. Pharmacists shall maintain adequate documentation of completion of acceptable formal continuing education and shall provide such documentation at the request of the department. Failure to provide such documentation upon the request of the department shall be an act of misconduct subject to disciplinary proceedings pursuant to section sixty-five hundred ten of this chapter.
6. The mandatory continuing education fee shall be forty-five dollars, shall be payable on or before the first day of each triennial registration period, and shall be paid in addition to the triennial registration fee required by section sixty-eight hundred five of this article.

1. No pharmacist shall administer immunizing agents without a certificate of administration issued by the department pursuant to regulations of the commissioner.
2. The fee for a certificate of administration shall be one hundred dollars and shall be paid on a triennial basis. A certificate may be suspended or revoked in the same manner as a license to practice pharmacy.

* NB Repealed July 1, 2020

1. Definition. The term "nonresident establishment" shall mean any pharmacy, manufacturer, wholesaler, or outsourcing facility located outside of the state that ships, mails or delivers prescription drugs or devices to other establishments, authorized prescribers and/or patients residing in this state. Such establishments shall include, but not be limited to, pharmacies that transact business through the use of the internet.
2. Registration. All nonresident establishments that ship, mail, or deliver prescription drugs and/or devices to other registered establishments, authorized prescribers, and/or patients into this state shall be registered with the department; except that such registration shall not apply to intra-company transfers between any division, affiliate, subsidiaries, parent or other entities under complete common ownership and control. The provisions of this subdivision shall apply solely to nonresident establishments and shall not affect any other provision of this article.
3. Agent of record. Each nonresident establishment that ships, mails or delivers drugs and/or devices into this state shall designate a resident agent in this state for service of process pursuant to rule three hundred eighteen of the civil practice law and rules.
4. Conditions of registration. As a condition of registration, a nonresident establishment shall comply with the following requirements:
   1. Be licensed and/or registered and in good standing with the state of residence;
   2. Maintain, in readily retrievable form, records of drugs and/or devices shipped into this state;
   3. Supply, upon request, all information needed by the department to carry out the department`s responsibilities under the laws and rules and regulations pertaining to nonresident establishments;
   4. Comply with all statutory and regulatory requirements of the state where the nonresident establishment is located, for prescription drugs or devices shipped, mailed or delivered into this state, except that for controlled substances shipped, mailed or delivered into this state, the nonresident pharmacy shall follow federal law and New York law relating to controlled substances;
   5. The application shall be made in the manner and form prescribed by the department;
   6. The application of establishments to be registered as a manufacturer, wholesaler or outsourcing facility of drugs and/or devices shall be accompanied by a fee as provided in section sixty-eight hundred eight of this article; and
   7. The application of establishments to be registered as a nonresident pharmacy shall be accompanied by a fee of three hundred forty-five dollars and shall be renewed triennially at a fee of two hundred sixty dollars.
5. Additional requirements. Nonresident pharmacies registered pursuant to this section shall:
   1. Provide a toll-free telephone number that is available during normal business hours and at least forty hours per week, to enable communication between a patient in this state and a pharmacist at the pharmacy who has access to the patient`s records; and
   2. Place such toll-free telephone number on a label affixed to each drug or device container.
6. Disciplinary action. Except in emergencies that constitute an immediate threat to public health, the department shall not prosecute a complaint or otherwise take formal action against a nonresident establishment based upon delivery of a drug into this state or a violation of law, rule, or regulation of this state if the agency having jurisdiction in the state where the nonresident establishment is based commences action on the violation complained of within one hundred twenty days from the date that the violation was reported; provided however, that the department may prosecute a complaint or take formal action against a nonresident establishment if it determines that the agency having jurisdiction in the state where the nonresident establishment is based has unreasonably delayed or otherwise failed to take prompt and appropriate action on a reported violation.
7. Revocation or suspension. A nonresident establishment that fails to comply with the requirements of this section shall be subject to revocation or suspension of its registration and other applicable penalties in accordance with the provisions of article one hundred thirty of this chapter.
8. Exception. The department may grant an exception from the registration requirements of this section on the application of a nonresident establishment that restricts its sale or dispensing of drugs and/or devices to residents of this state to isolated transactions.
9. Rules and regulations. The department shall promulgate rules and regulations to implement the provisions of this section.

1. No drug for which a prescription is required by the provisions of the Federal Food, Drug and Cosmetic Act or by the commissioner of health shall be distributed or dispensed to any person except upon a prescription written by a person legally authorized to issue such prescription. Such drug shall be compounded or dispensed by a licensed pharmacist, and no such drug shall be dispensed without affixing to the immediate container in which the drug is sold or dispensed a label bearing the name and address of the owner of the establishment in which it was dispensed, the date compounded, the number of the prescription under which it is recorded in the pharmacist's prescription files, the name of the prescriber, the name and address of the patient, and the directions for the use of the drug by the patient as given upon the prescription. All labels shall conform to such rules and regulations as promulgated by the commissioner pursuant to section sixty-eight hundred twenty-nine of this article. The prescribing and dispensing of a drug which is a controlled substance shall be subject to additional requirements provided in article thirty-three of the public health law. The words "drug" and "prescription required drug" within the meaning of this article shall not be construed to include soft or hard contact lenses, eyeglasses, or any other device for the aid or correction of vision. Nothing in this subdivision shall prevent a pharmacy from furnishing a drug to another pharmacy which does not have such drug in stock for the purpose of filling a prescription.
2. 1. A prescription may not be refilled unless it bears a contrary instruction and indicates on its face the number of times it may be refilled. A prescription may not be refilled more times than allowed on the prescription. The date of each refilling must be indicated on the original prescription. Prescriptions for controlled substances shall be refilled only pursuant to article thirty-three of the public health law.
      
      A pharmacy registered with the department pursuant to section sixty-eight hundred eight or sixty-eight hundred eight-b of this article may not deliver a new or refilled prescription off premises without the consent of the patient or an individual authorized to consent on the patient's behalf. For the purposes of this section, consent may be obtained in the same manner and process by which consent is deemed acceptable under the federal Medicare Part D program
   2. Pharmacy providers who deliver medication without patient or authorized individual consent will be required to accept the return of the medication from the patient, provide that patient credit for any charges they may have paid, and will be required to destroy those medications sent without consent on delivery in accordance with applicable state and federal law. Nothing in this section shall be deemed to interfere with the requirements for refill reminder or medication adherence programs. Nothing in this section is intended to apply to long-term care pharmacy dispensing and delivery.
3. A copy of a prescription for a controlled substance shall not be furnished to the patient but may be furnished to any licensed practitioner authorized to write such prescription. Copies of other prescriptions shall be furnished to the patient at his request, but such copies are issued for the informational purposes of the prescribers only, and shall be so worded.
4.  
   1. Oral prescriptions for controlled substances shall be filled pursuant to article thirty-three of the public health law. A pharmacist may fill an oral prescription for a drug, other than a controlled substance, made by a practitioner legally authorized to prescribe drugs. An oral authorization for the refill of a prescription, other than a prescription for a controlled substance, may be made by a practitioner legally authorized to prescribe drugs. The pharmacist receiving such oral authorization for the refill of a prescription shall write on the reverse side of the original prescription the date, time, and name of the practitioner authorizing the refill of the prescription. An oral prescription or an oral authorization for the refill of a prescription for the drug, other than a controlled substance, may be communicated by an employee of the prescribing practitioner; provided, however, the pharmacist shall:
      1. contemporaneously reduce such prescription to writing;
      2. dispense the substance in conformity with the labeling requirements applicable to a written prescription; and
      3. make a good faith effort to verify the employee's identity if the employee is unknown to the pharmacist.
   2. Oral prescriptions for patients in general hospitals, nursing homes, residential health care facilities as defined in section twenty-eight hundred one of the public health law, hospitals as defined in subdivision ten of section 1.03 of the mental hygiene law, or facilities operated by the office for people with developmental disabilities, may be communicated to a pharmacist serving as a vendor of pharmaceutical services based upon a contractual arrangement by an agent designated by and under the direction of the prescriber or the institution. Such agent shall be a health care practitioner currently licensed and registered under this title.
5. Records of all prescriptions filled or refilled shall be maintained for a period of at least five years and upon request made available for inspection and copying by a representative of the department. Such records shall indicate date of filling or refilling, doctor's name, patient's name and address and the name or initials of the pharmacist who prepared, compounded, or dispensed the prescription. Records of prescriptions for controlled substances shall be maintained pursuant to requirements of article thirty-three of the public health law.
6.  
   1. Every prescription written in this state by a person authorized to issue such prescription shall be on prescription forms containing one line for the prescriber's signature. The prescriber's signature shall validate the prescription. Every electronic prescription shall provide for the prescriber's electronic signature, which shall validate the electronic prescription. Imprinted conspicuously on every prescription written in this state in eight point upper case type immediately below the signature line shall be the words: "THIS PRESCRIPTION WILL BE FILLED GENERICALLY UNLESS PRESCRIBER WRITES 'd a w' IN THE BOX BELOW". Unless the prescriber writes d a w in such box in the prescriber's own handwriting or, in the case of electronic prescriptions, inserts an electronic direction to dispense the drug as written, the prescriber's signature or electronic signature shall designate approval of substitution by a pharmacist of a drug product pursuant to paragraph (o) of subdivision one of section two hundred six of the public health law. No other letters or marks in such box shall prohibit substitution. No prescription forms used or intended to be used by a person authorized to issue a prescription shall have 'd a w' preprinted in such box. Such box shall be placed directly under the signature line and shall be three-quarters inch in length and one-half inch in height, or in comparable form for an electronic prescription as may be specified by regulation of the commissioner. Immediately below such box shall be imprinted in six point type the words "Dispense As Written". Notwithstanding any other provision of law, no state official, agency, board or other entity shall promulgate any regulation or guideline modifying those elements of the prescription form's contents specified in this subdivision. To the extent otherwise permitted by law, a prescriber may modify only those elements of the prescription form's contents not specified in this subdivision. Notwithstanding any other provision of this section or any other law, when a generic drug is not available and the brand name drug originally prescribed is available and the pharmacist agrees to dispense the brand name product for a price that will not exceed the price that would have been charged for the generic substitute had it been available, substitution of a generic drug product will not be required. If the generic drug product is not available and a medical emergency situation, which for purposes of this section is defined as any condition requiring alleviation of severe pain or which threatens to cause disability or take life if not promptly treated, exists, then the pharmacist may dispense the brand name product at his regular price. In such instances the pharmacist must record the date, hour and nature of the medical emergency on the back of the prescription and keep a copy of all such prescriptions .
   2. *Notwithstanding any other provision of this section or any other law, when an interchangeable biological product is not available and the biological product originally prescribed is available and the pharmacist agrees to dispense the prescribed biological product for a price that will not exceed the price that would have been charged for the interchangeable biological substitute had it been available, substitution of an interchangeable biological product will not be required. If the interchangeable biological product is not available and a medical emergency situation, which for purposes of this section is defined as any condition requiring alleviation of severe pain or which threatens to cause disability or take life if not promptly treated, exists, then the pharmacist may dispense the prescribed biological product at his regular price. In such instances the pharmacist must record the date, hour and nature of the medical emergency on the back of the prescription and keep a copy of all such prescriptions.
      *NB Effective until October 23, 2022
   2. *The prescriber shall inform the patient whether he or she has prescribed a brand name or its generic equivalent drug product.
      * NB Effective October 23, 2022
   3. *The prescriber shall inform the patient whether he or she has prescribed a brand name or its generic equivalent drug product or interchangeable biological product.
      * NB Effective until October 23, 2022
   3. *The provisions of this subdivision shall not apply to a hospital as defined in article twenty-eight of the public health law.
      * NB Effective October 23, 2022
   4. *The provisions of this subdivision shall not apply to a hospital as defined in article twenty-eight of the public health law.
      * NB Effective until October 23, 2022
   4. *No prescriber shall be subjected to civil liability arising solely from authorizing, in accordance with this subdivision, the substitution by a pharmacist of a drug product pursuant to paragraph (o) of subdivision one of section two hundred six of the public health law.
      * NB Effective October 23, 2022
   5. *No prescriber shall be subjected to civil liability arising solely from authorizing, in accordance with this subdivision, the substitution by a pharmacist of a drug product pursuant to paragraph (o) of subdivision one of section two hundred six of the public health law.
      * NB Expires October 23, 2022
7.  
   1. No prescription for a drug written in this state by a person authorized to issue such prescription shall be on a prescription form which authorizes the dispensing or compounding of any other drug. No drug shall be dispensed by a pharmacist when such prescription form includes any other drug.
   2. With respect to drugs other than controlled substances, the provisions of this subdivision shall not apply to pharmacists employed by or providing services under contract to general hospitals, nursing homes, residential health care facilities as defined in section twenty-eight hundred one of the public health law, hospitals as defined in subdivision ten of section 1.03 of the mental hygiene law, or facilities operated by the office for people with developmental disabilities, who dispense drugs in the course of said employment or in the course of providing such services under contract. With respect to such pharmacists, each prescription shall be transcribed on a patient specific prescription form.
8. Every prescription (whether or not for a controlled substance) written in this state by a person authorized to issue such prescription and containing the prescriber's signature shall, in addition to such signature, be imprinted or stamped legibly and conspicuously with the printed name of the prescriber who has signed the prescription. The imprinted or stamped name of the signing prescriber shall appear in an appropriate location on the prescription form and shall not be entered in or upon any space or line reserved for the prescriber's signature. The imprinted or stamped name shall not be employed as a substitute for, or fulfill any legal requirement otherwise mandating that the prescription be signed by the prescriber.
9. No person, corporation, association or other entity, not licensed to issue a prescription pursuant to this title, shall wilfully cause prescription forms, blanks or facsimiles thereof to be disseminated to any person other than a person who is licensed to issue a prescription pursuant to this title. A violation of this subdivision shall be a class B misdemeanor punishable in accordance with the provisions of the penal law.
10. Notwithstanding any other provision of this section or any other law to the contrary, effective three years subsequent to the date on which regulations establishing standards for electronic prescriptions are promulgated by the commissioner of health, in consultation with the commissioner pursuant to subdivision three of section two hundred eighty-one of the public health law, no practitioner shall issue any prescription in this state, unless such prescription is made by electronic prescription from the practitioner to a pharmacy, except for prescriptions: (a) issued by veterinarians; (b) issued or dispensed in circumstances where electronic prescribing is not available due to temporary technological or electrical failure, as set forth in regulation; (c) issued by practitioners who have received a waiver or a renewal thereof for a specified period determined by the commissioner of health, not to exceed one year, from the requirement to use electronic prescribing, pursuant to a process established in regulation by the commissioner of health, in consultation with the commissioner due to economic hardship, technological limitations that are not reasonably within the control of the practitioner, or other exceptional circumstance demonstrated by the practitioner; (d) issued by a practitioner under circumstances where, notwithstanding the practitioner's present ability to make an electronic prescription as required by this subdivision, such practitioner reasonably determines that it would be impractical for the patient to obtain substances prescribed by electronic prescription in a timely manner, and such delay would adversely impact the patient's medical condition, provided that if such prescription is for a controlled substance, the quantity that does not exceed a five day supply if the controlled substance was used in accordance with the directions for use; or (e) issued by a practitioner to be dispensed by a pharmacy located outside the state, as set forth in regulation.
     
11. 10-a. A pharmacy that receives an electronic prescription from the person issuing the prescription may, if the prescription has not been dispensed and at the request of the patient or a person authorized to make the request on behalf of the patient, immediately transfer or forward such prescription to an alternative pharmacy designated by the requesting party.

11. In the case of a prescription issued by a practitioner under paragraph (b) of subdivision ten of this section, the practitioner shall be required to indicate in the patient's health record that the prescription was issued other than electronically due to temporary technological or electrical failure.
12. In the case of a prescription issued by a practitioner under paragraph (d) or (e) of subdivision ten of this section, the practitioner shall, upon issuing such prescription, indicate in the patient's health record either that the prescription was issued other than electronically because it (a) was impractical to issue an electronic prescription in a timely manner and such delay would have adversely impacted the patient's medical condition, or (b) was to be dispensed by a pharmacy located outside the state.
13. The waiver process established in regulation pursuant to paragraph(c) of subdivision ten of this section shall provide that a practitioner prescribing under a waiver must notify the department of health in writing promptly upon gaining the capability to use electronic prescribing, and that a waiver shall terminate within a specified period of time after the practitioner gains such capability.
14. Notwithstanding any other provision of law to the contrary, no outsourcing facility may distribute or dispense any drug to any person pursuant to a prescription unless it is also registered as a pharmacy in this state and meets all other applicable requirements of federal and state law.
15. *Notwithstanding any other provisions of this section or any other law to the contrary, a practitioner shall not be required to issue prescriptions electronically if he or she certifies to the department of health, in a manner specified by the department of health, that he or she will not issue more than twenty-five prescriptions during a twelve month period. Prescriptions in both oral and written form for both controlled substances and non-controlled substances shall be included in determining whether the practitioner will reach the limit of twenty-five prescriptions.
    1. A certification shall be submitted in advance of the twelve-month certification period, except that a twelve-month certification submitted on or before on July first,two thousand sixteen, may begin March twenty-seventh, two thousand sixteen.
    2. A practitioner who has made a certification under this subdivision may submit an additional certification on or before the expiration of the current twelve-month certification period, for a maximum of three twelve-month certifications.
    3. A practitioner may make a certification under this subdivision regardless of whether he or she has previously received a waiver under paragraphs (c) of subdivision ten of this section.

    *NB Repealed June 1, 2020