Which federal action sets the standards for quality and requires proper medication labeling for preparations containing morphine?

§6800. Introduction.

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.

*§6801. Definition of practice of pharmacy. (duplicate)

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.

*NB Effective until July 1, 2022

*§6801. Definition of practice of pharmacy. (duplicate)

The practice of the profession of pharmacy is defined as the 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.

*NB Effective and Repealed July 1, 2022

*§6801. Definition of practice of pharmacy.

The practice of the profession of pharmacy is defined as the preparing, compounding, preserving, or the dispensing of drugs, medicines and therapeutic devices on the basis of prescriptions or other legal authority.

*NB Effective July 1, 2022

*§6801-a. Collaborative drug therapy management demonstration program.

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

§6802. Definitions.

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.

1. "Formulary" means the latest edition of the official national formulary, and its supplement.
2. "Pharmacopeia", when not otherwise limited, means the latest edition of the official United States pharmacopeia, and its supplement.
3. "Homeopathic pharmacopeia" means the official homeopathic pharmacopeia of the United States, and its supplement.
4. "Official compendium" means the official United States pharmacopeia, official homeopathic pharmacopeia of the United States, official national formulary, or their supplements.
5. "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.
6. "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.
7. "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.
8. "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.
9. "Immediate container" does not include package liners.
10. "Labeling" means all labels and other written, printed or pictorial matter: a. Upon any drug, device or cosmetic or any of its containers or wrappers, or b. Accompanying such drug, device or cosmetic.
11. "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.
12. "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.
13. "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.
14. "Device" means instruments, apparatus, and contrivances, including their components, parts and accessories, intended:
    1. For use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or animals; or
    2. To affect the structure or any function of the body of man or animals.
15. 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.
16. "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.
17. "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.
18. "Controlled substance" means any drug defined as a controlled substance by article thirty-three of the public health law.
19. "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.
20. "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.
21. "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.
22. "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.
23. "Outsourcing facility" means a facility that:
    1. is engaged in the compounding of sterile drugs;
    2. is currently registered as an outsourcing facility with the Secretary of Health and Human Services; and
    3. complies with all applicable requirements of federal and state law, including the Federal Food, Drug and Cosmetic Act.
24. "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.
25. * "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).

    * NB Expires October 23, 2022

26. * "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."

    * NB Expires October 23, 2022

*§6804. State board of pharmacy.

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

§6805. Requirements for a professional license.

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.

§6806. Limited permits.

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.

§6807. Exempt persons.

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.

§6808. Registering and operating establishments.

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.

§6808-b. Registration of nonresident establishments.

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.

§6810. Prescriptions.

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
   1. *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
   2. *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
   1. *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
   2. *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
   1. *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
   2. *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.

1. 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.
2. 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.
3. 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.
4. 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.
5. *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

§6811. Misdemeanors.

It shall be a class A misdemeanor for:

1. Any person knowingly or intentionally to prevent or refuse to permit any board member or department representative to enter a pharmacy or any other establishment for the purpose of lawful inspection;
2. Any person whose license has been revoked to refuse to deliver the license;
3. Any pharmacist to display his license or permit it to be displayed in a pharmacy of which he is not the owner or in which he is not employed, or any owner to fail to display in his pharmacy the license of the pharmacist employed in said pharmacy;
4. Any holder of a license to fail to display the license;
5. Any owner of a pharmacy to display or permit to be displayed in his pharmacy the license of any pharmacist not employed in said pharmacy;
6. Any person to carry on, conduct or transact business under a name which contains as a part thereof the words "drugs", "medicines", "drug store", "apothecary", or "pharmacy", or similar terms or combination of terms, or in any manner by advertisement, circular, poster, sign or otherwise describe or refer to the place of business conducted by such person, or describe the type of service or class of products sold by such person, by the terms "drugs", "medicine", "drug store", "apothecary", or "pharmacy", unless the place of business so conducted is a pharmacy licensed by the department;
7. Any person to enter into an agreement with a physician, dentist, podiatrist or veterinarian for the compounding or dispensing of secret formula (coded) prescriptions;
8. Any person to sell or distribute any instrument or article, or any recipe, drug or medicine for the prevention of conception to a minor under the age of sixteen years; the sale or distribution of such to a person other than a minor under the age of sixteen years is authorized only by a licensed pharmacist but the advertisement or display of said articles, within or without the premises of such pharmacy is hereby prohibited; [Injunction - Injunctive relief against enforcement of subd. 8 of this section which prohibited distribution of contraceptives to persons under the age of 16, which prohibited distribution of contraceptives to any other persons by persons other than pharmacists, and which prohibited any display or advertisement of contraceptives was appropriate. Population Services Intern. V. Wilson, D.C.N.Y. 1975, 398 F. Supp. 321, 97 S.Ct. 2010, 431 U.S. 678, 52 L.Ed.2d 675.]
9. Any person to manufacture, sell, deliver for sale, hold for sale or offer for sale of any drug, device or cosmetic that is adulterated or misbranded;
10. Any person to adulterate or misbrand any drug, device or cosmetic;
11. Any person to receive in commerce any drug, device or cosmetic that is adulterated or misbranded, and to deliver or proffer delivery thereof for pay or otherwise;
12. Any person to sell, deliver for sale, hold for sale, or offer for sale any drug, device or cosmetic in violation of this article;
13. Any person to disseminate any false advertisement;
14. Any person to refuse to permit entry or inspection as authorized by this article;
15. Any person to forge, counterfeit, simulate, or falsely represent, or without proper authority using any mark, stamp, tag, label or other identification device authorized or required by rules and regulations promulgated under the provisions of this article;
16. Any person to use for his own advantage, or reveal, other than to the commissioner or his duly authorized representative, or to the courts when relevant in any judicial proceedings under this article, any information acquired under authority of this article or concerning any method or process, which is a trade secret;
17. Any person to alter, mutilate, destroy, obliterate or remove the whole or any part of the labeling of, or the doing of any other act with respect to a drug, device, or cosmetic, if such act is done while such article is held for sale and results in such article being misbranded;
18. Any person to use on the labeling of any drug or in any advertising relating to such drug any representation or suggestion that an application with respect to such drug is effective under section sixty-eight hundred seventeen of this chapter or that such is in compliance with the provisions of such section;
19. Any person to violate any of the provisions of section sixty-eight hundred ten of this article;
20. Any person to violate any of the provisions of section sixty-eight hundred sixteen of this article;
21. Any person, to sell at retail or give away in tablet form bichloride of mercury, mercuric chloride or corrosive sublimate, unless such bichloride of mercury, mercuric chloride or corrosive sublimate, when so sold, or given away, shall conform to the provisions of national formulary XII. Nothing contained in this paragraph shall be construed to prohibit the sale and dispensing of bichloride of mercury in any form, shape, or color, when combined or compounded with one or more other drugs or excipients, for the purposes of internal medication only, or when sold in bulk in powder form, or to any preparation containing one-tenth of a grain or less of bichloride of mercury;
22. Any pharmacy to fail to properly post the list required by section sixty-eight hundred twenty-six of this article;
23. Any pharmacy to change its current selling price without changing the listed price as provided by section sixty-eight hundred twenty-six of this article;
24. Any person to refuse to permit access to or copying of any record as required by this article; or
25. Any manufacturer to sell or offer for sale any drug not manufactured, prepared or compounded under the personal supervision of a chemist or licensed pharmacist or not labeled with the full name of the manufacturer or seller.
26. Any outsourcing facility to sell or offer to sell any drug that is not both compounded under the personal supervision of a licensed pharmacist and labeled with the full name of the outsourcing facility.

§6811-a. Certain drugs to be clearly marked or labeled.

1. Except as otherwise authorized in the Federal Food, Drug and Cosmetic Act, 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 may be manufactured or commercially distributed within this state in tablet or capsule form unless it has clearly marked or imprinted on each such tablet or capsule in conformance with the applicable plan required by subdivision three of this section:
   1. an individual symbol, number, company name, words, letters, marking or National Drug Code (hereinafter referred to as N. D. C.) number identifying the manufacturer or distributor of the drug; and
   2. an N. D. C. number, symbol, number, letters, words or marking identifying such drug or combination of drugs.
2. Except as otherwise authorized in the Federal Food, Drug and Cosmetic Act, no drug for which any prescription is required by the provisions of the Federal Food, Drug and Cosmetic Act or by the commissioner of health contained within a bottle, vial, carton or other container, or in any way affixed or appended to or enclosed within a package of any kind, and designed or intended for delivery in such container or package to an ultimate consumer, shall be manufactured or distributed within this state unless such container or package has clearly and permanently marked or imprinted upon it in conformance with the applicable plan required by subdivision three of this section:
   1. an individual symbol, N. D. C. number, company name, number, letters, words or marking identifying the manufacturer or distributor of the drug;
   2. an N. D. C. number, symbol, number, letters, words or marking identifying such drug or combination of drugs; and
   3. whenever the distributor of the prescription drug product does not also manufacture the product the names and places of business of both shall appear on the label in words clearly distinguishing each.
3. 1. Each manufacturer and distributor shall prepare and submit to the commissioner of health a proposed plan of the manufacturer or distributor, as the case may be, to have its products comply with the marking and labeling requirements of this section.
   2. Such plan shall be in writing and shall give the respective dates by which the various products manufactured or distributed will each contain the required mark or label. The plan shall state the reasons why the projected date of compliance has been proposed and such other information deemed relevant or that the commissioner of health shall require.
   3. The commissioner may either approve the plan as proposed or, after consultation with the manufacturer or distributor, require an amendment or the commissioner may promulgate a plan for the manufacturer or distributor. No plan or amendment to the plan shall be effective until approved or promulgated by the commissioner of health upon a finding by him that the time limitations provided for therein are reasonable and will best carry out the intendment of this section.
4. Each manufacturer and/or distributor shall publish and make available, upon request, to the department of education, to each physician, dentist, pharmacy, hospital or other institution wherein such drugs may be used, a printed material which will identify each imprint used by the manufacturer or distributor. Updated materials shall be provided as changes occur, upon the filing of an annual request. The provisions of this subdivision shall be deemed to be complied with when a prescription drug product is included in the Physician's Desk Reference.
5. Every person, firm or corporation violating the provisions of this section for any prescription drug product shall be guilty of an offense punishable by a fine of not less than twenty-five hundred dollars nor more than ten thousand dollars. Any prescription drug product prepared or manufactured in violation of this section shall be contraband and subject to seizure either by the state board of pharmacy or by any law enforcement officer of the state.
6. The provisions of this section shall not apply to any tablet or capsule which contains a controlled substance as that term is defined by article thirty-three of the public health law or which is prepared or manufactured by a pharmacist duly licensed by the state which is made by him for the purpose of retail sale from his principal place of business and not intended for resale.
7. The commissioner of health may exempt a particular tablet or capsule from the requirements of this section, upon application by a manufacturer, on the grounds that labeling such a tablet or capsule is unfeasible because of size or texture or other unique characteristics.
8. 1. As used in this section, the term "distributor" means the person, firm, corporation or other entity which is not the actual manufacturer of a prescription drug product but which distributes such product for resale under the label of such person, firm, corporation or entity.
   2. For purposes of subdivision four "drug product" means the entire supply of the finished dosage form of the drug.

§6811-b. Door-to-door distribution of drugs prohibited.

It shall be a violation, punishable by a fine not to exceed two hundred fifty dollars, for a manufacturer, distributor, or seller of drugs or an employee or agent thereof to distribute a free sample of any drug, other than a cosmetic not intended for ingestion, to any residential dwelling unless the sample is given directly to a person who is, or reasonably appears to be, over the age of eighteen. This section shall not be construed to permit distribution where otherwise prohibited by this chapter or any other law.

§6812. Special provisions.

§6812. Special Provisions

1. Where any pharmacy, manufacturer, wholesaler or outsourcing facility registered by the department is damaged by fire the board shall be notified within a period of forty-eight hours, and the board shall have power to impound all drugs for analysis and condemnation, if found unfit for use. Where a pharmacy is discontinued, the owner of its prescription records shall notify the department as to the disposition of said prescription records, and in no case shall records be sold or given away to a person who does not currently possess a registration to operate a pharmacy.
2. Nothing in this article shall be construed as requiring the prosecution or the institution of injunction proceedings for minor violations of this article whenever the public interest will be adequately served by a suitable written notice of warning.
3. The executive secretary of the state board of pharmacy 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.

§6813. Seizure.

1. Any drug, device or cosmetic that is adulterated, misbranded or may not be sold under the provisions of this chapter, may be seized on petition or complaint of the board and condemned in the supreme court of any county in which it is found. Seizure shall be made:
   1. by process pursuant to the petition or complaint, or
   2. if the secretary or other officer designated by him has probable cause to believe that the article
      1. is one which may not be sold under the provisions of section sixty-eight hundred seventeen of this chapter, or
      2. is adulterated, or
      3. is so misbranded as to be dangerous to health. The article shall be seized by order of such officer. The order shall describe the article to be seized, the place where the article is located, and the officer or employee making the seizure. The officer, in lieu of taking actual possession, may affix a tag or other appropriate marking to the article giving notice that the article has been quarantined and warning all persons not to remove or dispose of it by sale or otherwise until permission for removal or disposal is given by the officer or the court. In case of seizures or quarantine, pursuant to such order, the jurisdiction of such court shall attach upon such seizure or quarantine, and a petition or complaint for condemnation shall be filed promptly.
2. The procedure for cases under this section shall conform as much as possible to the procedure for attachment. Any issue of fact joined in any case under this section shall be tried by jury on the demand of either party. The court at any time after seizure and up to the time of trial shall allow by order any party or his agent or attorney to obtain a representative sample of the condemned material, a true copy of the analysis on which the proceeding was based, and the identifying marks or numbers, if any, on the packages from which the samples analyzed were obtained.
3. Any drug, device or cosmetic condemned under this section shall be disposed of by destruction or sale as the court may direct after the decree in accordance with the provisions of this section. The proceeds of the sale, if any, shall be paid into the state treasury after deduction for legal costs and charges. However, the drug, device or cosmetic shall not be sold contrary to the provisions of this article. After entry of the decree, if the owner of the condemned articles pays the costs of the proceeding and posts a sufficient bond as security that the articles will not be disposed of contrary to the provisions of this article, the court may by order direct that the seized articles be delivered to the owner to be destroyed or brought into conformance with this article under supervision of the secretary. The expenses of the supervision shall be borne by the person obtaining the release under bond. Any drug condemned by reason of its being a new drug which may not be sold under this article shall be disposed of by destruction.
4. When the decree of condemnation is entered, court costs and fees, storage and other expense shall be awarded against the person, if any, intervening as claimant of the condemned articles.
5. In any proceeding against the board, or the secretary, or an agent of either, because of seizure, or quarantine, under this section, the board, or the secretary, or such agent shall not be liable if the court finds that there was probable cause for the acts done by them.

§6814. Records of shipment.

For the purpose of enforcing provisions of this article, carriers engaged in commerce, and persons receiving drugs, devices or cosmetics in commerce or holding such articles so received, shall, upon the request of an officer duly assigned by the secretary, permit such officer, at reasonable times, to have access to and to copy all records showing the movement in commerce of any drug, device or cosmetic, or the holding thereof during or after such movement, and the quantity, shipper, and consignee thereof: and it shall be unlawful for any such carrier or person to fail to permit such access to and copying of any such record so requested when such request is accompanied by a statement in writing specifying the nature or kind of drug, device or cosmetic to which such request relates: Provided, that evidence obtained under this section shall not be used in a criminal prosecution of the person from whom obtained: Provided further, that carriers shall not be subject to the other provisions of this article by reason of their receipt, carriage, holding or delivery of drugs, devices or cosmetics in the usual course of business as carriers.

§6815. Adulterating, misbranding and substituting.

1. Adultered drugs. A drug or device shall be deemed to be adulterated:
   1.  
      1. If it consists in whole or in part of any filthy, putrid, or decomposed substance; or
      2. if it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health; or
      3. if it is a drug and its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or
      4. if it is a drug and it bears or contains, for purposes of coloring only, a coal-tar color other than one from a batch that has been certified in accordance with regulations provided in this article.
   2. If it purports to be, or is represented as, a drug the name of which is recognized in an official compendium, and its strength differs from, or its quality or purity falls below, the standard set forth in such compendium. Such determination as to strength, quality or purity shall be made in accordance with the tests or methods of assay set forth in such compendium, or, in the absence or inadequacy of such tests or methods of assay, then in accordance with tests or methods of assay prescribed by regulations of the board of pharmacy as promulgated under this article. Deviations from the official assays may be made in the quantities of samples and reagents employed, provided they are in proportion to the quantities stated in the official compendium. No drug defined in an official compendium shall be deemed to be adulterated under this paragraph because (1) it exceeds the standard of strength therefor set forth in such compendium, if such difference is plainly stated on its label; or (2) it falls below the standard of strength, quality, or purity therefor set forth in such compendium if such difference is plainly stated on its label, except that this clause shall apply only to such drugs, or classes of drugs, as are specified in regulations which the board shall promulgate when, as applied to any drug, or class of drugs, the prohibition of such difference is not necessary for the protection of the public health. Whenever a drug is recognized in both the United States pharmacopoeia and the homeopathic pharmacopoeia of the United States, it shall be subject to the requirements of the United States pharmacopoeia unless it is labeled and offered for sale as a homeopathic drug, in which case it shall be subject to the provisions of the homeopathic pharmacopoeia of the United States and not to those of the United States pharmacopoeia.
   3. If it is not subject to the provisions of paragraph b of this subdivision and its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
   4. If it is a drug and any substance has been
      1. mixed or packed therewith so as to reduce its quality or strength or
      2. substituted wholly or in part therefor.
   5. If it is sold under or by a name not recognized in or according to a formula not given in the United States pharmacopoeia or the national formulary but that is found in some other standard work on pharmacology recognized by the board, and it differs in strength, quality or purity from the strength, quality or purity required, or the formula prescribed in, the standard work.
2. Misbranded and substituted drugs and devices. A drug or device shall be deemed to be misbranded:
   1. If its labeling is false or misleading in any particular.
   2. If in package form, unless it bears a label containing (1) the name and place of business of the manufacturer, packer, or distributor; and (2) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count: Provided, that under clause (2) of this paragraph the board may establish reasonable variations as to quantity and exemptions as to small packages.
   3. If any word, statement, or other information required by or under authority of this article to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
   4. If it is for use by man and contains any quantity of the narcotic or hypnotic substance alpha eucaine, barbituric acid, beta eucaine, bromal, cannabis, carbromal, chloral, coca, cocaine, codeine, heroin, marihuana, morphine, opium, paraldehyde, peyote, or sulphonmethane; or any chemical derivative of such substance, which derivative has been by the secretary, after investigation, found to be, and by regulations under this article, or by regulations promulgated by the board, designated as, habit forming; unless its label bears the name and quantity, or proportion, of such substance or derivative and in juxtaposition therewith the statement "Warning--May be habit forming."
   5. If it is a drug and is not designated solely by a name recognized in an official compendium unless its label bears (1) the common or usual name of the drug, if such there be; and (2) in case it is fabricated from two or more ingredients, the common or usual name of each active ingredient, including the kind and quantity by percentage or amount of any alcohol, and also including, whether active or not, the name and quantity or proportion of any bromides, ether, chloroform, acetanilid, acetphenetidin, amidopyrine, antipyrine, atropine, hyoscine, hyoscyamine, arsenic, digitalis, digitalis glucosides, mercury, ouabain, strophanthin, strychnine, thyroid, or any derivative or preparation of any such substances, contained therein: Provided, that, to the extent that compliance with the requirements of clause (2) of this paragraph is impracticable, exemptions shall be established by regulations promulgated by the board.
   6. Unless its labeling bears (1) adequate directions for use; and (2) such adequate warnings against use in those pathological conditions orby children where its use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application, in such manner and form, as are necessary for the protection of users: Provided, that, where any requirement of clause (1) of this paragraph, as applied to any drug or device, is not necessary for the protection of the public health, the board shall promulgate regulations exempting such drug or device from such requirement.
   7. If it purports to be a drug the name of which is recognized in an official compendium, unless it is packaged and labeled as prescribed therein: Provided, that, the method of packing may be modified with the consent of the secretary in accordance with regulations promulgated by the board. Whenever a drug is recognized in both the United States pharmacopoeia and the homeopathic pharmacopoeia of the United States, it shall be subject to the requirements of the United States pharmacopoeia with respect to packaging and labeling unless it is labeled and offered for sale as a homeopathic drug, in which case it shall be subject to the provisions of the homeopathic pharmacopoeia of the United States, and not to those of the United States pharmacopoeia.
   8. 1. If it is a drug and its container is so made, formed or filled as to be misleading;
      2. If it is an imitation of another drug; (3) if it is offered for sale under the name of another drug; or
      3. If it bears a copy, counterfeit, or colorable imitation of the trademark, label, container or identifying name or design of another drug.
   9. If it is dangerous to health when used in the dosage, or with the frequency or duration prescribed, recommended or suggested in the labeling thereof.
   10. Except as required by article thirty-three of the public health law, the labeling provisions of this article shall not apply to the compounding and dispensing of drugs on the written prescription of a physician, a dentist, a podiatrist or a veterinarian, which prescription when filled shall be kept on file for at least five years by the pharmacist or druggist. Such drug shall bear a label containing the name and place of business of the dispenser, the serial number and date of the prescription, directions for use as may be stated in the prescription, name and address of the patient and the name of the physician or other practitioner authorized by law to issue the prescription. In addition, such label shall contain the proprietary or brand name of the drug and, if applicable, the strength of the contents, unless the person issuing the prescription explicitly states on the prescription, in his own handwriting, that the name of the drug and the strength thereof should not appear on the label.

§6816. Omitting to label drugs, or labeling them wrongly.

1.  
   1. Any person, who, in putting up any drug, medicine, or food or preparation used in medical practice, or making up any prescription, or filling any order for drugs, medicines, food or preparation puts any untrue label, stamp or other designation of contents upon any box, bottle or other package containing a drug, medicine, food or preparation used in medical practice, or substitutes or dispenses a different article for or in lieu of any article prescribed, ordered, or demanded, except where required pursuant to section sixty-eight hundred sixteen-a of this article, or puts up a greater or lesser quantity of any ingredient specified in any such prescription, order or demand than that prescribed, ordered or demanded, except where required pursuant to paragraph (g) of subdivision two of section three hundred sixty-five-a of the social services law, or otherwise deviates from the terms of the prescription, order or demand by substituting one drug for another, except where required pursuant to section sixty-eight hundred sixteen-a of this article, is guilty of a misdemeanor; provided, however, that except in the case of physicians' prescriptions, nothing herein contained shall be deemed or construed to prevent or impair or in any manner affect the right of an apothecary, druggist, pharmacist or other person to recommend the purchase of an article other than that ordered, required or demanded, but of a similar nature, or to sell such other article in place or in lieu of an article ordered, required or demanded, with the knowledge and consent of the purchaser. Upon a second conviction for a violation of this section the offender must be sentenced to the payment of a fine not to exceed one thousand dollars and may be sentenced to imprisonment for a term not to exceed one year. The third conviction of a violation of any of the provisions of this section, in addition to rendering the offender liable to the penalty prescribed by law for a second conviction, shall forfeit any right which he may possess under the law of this state at the time of such conviction, to engage as proprietor, agent, employee or otherwise, in the business of an apothecary, pharmacist, or druggist, or to compound, prepare or dispense prescriptions or orders for drugs, medicines or foods or preparations used in medical practice; and the offender shall be by reason of such conviction disqualified from engaging in any such business as proprietor, agent, employee or otherwise or compounding, preparing or dispensing medical prescriptions or orders for drugs, medicines, or foods or preparations used in medical practice.
   2. The provisions of this section shall not apply to the practice of a practitioner who is not the proprietor of a store for the dispensing or retailing of drugs, medicines and poisons, or who is not in the employ of such a proprietor, and shall not prevent practitioners from supplying their patients with such articles as they may deem proper, and except as to the labeling of poisons shall not apply to the sale of medicines or poisons at wholesale when not for the use or consumption by the purchaser; provided, however, that the sale of medicines or poisons at whole-sale shall continue to be subject to such regulations as from time to time may be lawfully made by the board of pharmacy or by any competent board of health.
   3. The provisions of this section shall not apply to a limited pharmacy which prepares a formulary containing the brand names and the generic names of drugs and of manufacturers which it stocks, provided that it furnishes a copy of such formulary to each physician on its staff and the physician signs a statement authorizing the hospital to supply the drug under any generic or non-proprietary name listed therein and in conformity with the regulations of the commissioner of education.
2. For the purposes set forth in this section, the terms prescription, order or demand shall apply only to those items subject to provisions of subdivision one of section sixty-eight hundred ten of this chapter. The written order of a physician for items not subject to provisions of subdivision one of section sixty-eight hundred ten of this chapter shall be construed to be a direction, a fiscal order or a voucher.

§6816-a. When substitution is required.

1. A pharmacist shall substitute a less expensive drug product containing the same active ingredients, dosage form and strength as the drug product prescribed, ordered or demanded, provided that the following conditions are met:
   1. The prescription is written on a form which meets the requirements of subdivision six of section sixty-eight hundred ten of this article and the prescriber does not prohibit substitution, or in the case of oral prescriptions, the prescriber must expressly state whether substitution is to be permitted or prohibited. Any oral prescription that does not include such an express statement shall not be filled; and
   2. The substituted drug product is contained in the list of drug products established pursuant to paragraph (o) of subdivision one of section two hundred six of the public health law; and
   3. The pharmacist shall indicate on the label affixed to the immediate container in which the drug is sold or dispensed the name and strength of the drug product and its manufacturer unless the prescriber specifically states otherwise. The pharmacist shall record on the prescription form the brand name or the name of the manufacturer of the drug product dispensed.
2. In the event a patient chooses to have a prescription filled by an out of state dispenser, the laws of that state shall prevail.
3. *A pharmacist shall substitute a less expensive biological product for a prescribed biological product provided that all of the following conditions are met:
   1. the substituted biological product is either an interchangeable biological product for the prescribed product or the substituted biological product is one for which the prescribed product is an interchangeable biological product;
   2. the prescriber does not designate that a substitution is prohibited as described in subdivision six of section sixty-eight hundred ten of this article; and
   3. the pharmacist indicates on the label affixed to the immediate container in which the biological product is sold or distributed the name and strength of the product and its manufacturer unless the prescriber specifically states otherwise.
   * NB Expires October 23, 2022
4. *
   1. Within five business days following the dispensing of a substituted biological product, the dispensing pharmacist or the pharmacist's designee shall communicate to the prescriber the specific product provided to the patient, including the name of the product and the manufacturer. The communication shall be conveyed to the prescriber (i) by making an entry that is electronically accessible to the prescriber through an interoperable electronic medical records system, an electronic prescribing technology or a pharmacy record; or (ii) by using facsimile, electronic transmission or other electronic means. If an electronic means described in this paragraph is not available to the pharmacist at the time of communication, the dispensing pharmacist or the pharmacist's designee may communicate the information by telephone.
   2. Communication under paragraph (a) of this subdivision shall not be required where:
      1. there is no FDA-approved interchangeable biological product for the product prescribed; or
      2. a refill prescription is not changed from the product dispensed on the prior filling of the prescription.
   * NB Expires October 23, 2022
5. *The department shall maintain a link on its web site to the current list of all biological products determined by the Federal Food and Drug Administration to be an interchangeable biological product for a specific biological product.
   * NB Expires October 23, 2022

§6817. New drugs.

1. Except as otherwise provided in the Federal Food, Drug and Cosmetic Act, no person shall sell, deliver, offer for sale, hold for sale, or give away any new drug, unless:
   1. an application with respect thereto has become effective, or in the case of an investigational drug the sponsor has complied with the applicable requirements, under the Federal Food, Drug, and Cosmetic Act, or
   2. when not subject to such act, such drug has been tested and has not been found to be unsafe or ineffective for use under the conditions prescribed, recommended or suggested in the labeling thereof, and, prior to selling or offering for sale such drug, there has been filed with the department an application setting forth
      1. full reports of investigations which have been made to show whether or not such drug is safe and effective for use;
      2. a full list of the ingredients used as components of such drug;
      3. a full statement of the composition of such drug;
      4. a full description of the methods used in, and the facilities and controls used for, the manufacture, processing and packing of such drugs;
      5. such samples of such drug and of the ingredients used as components thereof as the board or secretary may require; and
      6. specimens of the labeling proposed to be used for such drug.
2. An application provided for in paragraph b of subdivision one shall become effective on the one hundred eightieth day after the filing thereof, except that if the secretary or board finds, after due notice to applicant and giving him an opportunity for a hearing, that the drug is not safe and effective for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof, he shall, prior to the effective date of the application, issue an order refusing to permit the application to become effective.
3. A drug dispensed on a written or oral prescription of a physician, dentist, podiatrist or veterinarian (except a controlled substance), shall be exempt from the requirements of this section if such drug bears a label containing the name and place of business of the dispenser, the serial number and date of the prescription, directions for use as may be stated in the prescription and the name of the physician, dentist, podiatrist or veterinarian issuing the prescription and the name of the patient. 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 explicitly states on the prescription, in his own handwriting, that the name of the drug and the strength thereof should not appear on the label.
4. The board shall promulgate regulations for exempting from the operation of this section drugs (and with the concurrence of the commissioner of health, pursuant to article thirty-three of the public health law, controlled substances) intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety and efficacy of drugs and labeled "For Investigational Use Only". Such regulations may, within the discretion of the board, among other conditions relating to the protection of the public health, provide for conditioning such exemptions upon:
   1. The submission to the secretary before any clinical testing of a new drug is undertaken of reports by the manufacturer or sponsor of the investigation of such drug, of preclinical tests, including tests on animals of such drug adequate to justify the proposed clincial testing.
   2. The manufacturer or the sponsor of the investigation of a new drug proposed to be distributed to investigators for clinical testing obtaining a signed agreement from each of such investigators that patients to whom the drug is administered will be under his personal supervision, or under the supervision of investigators responsible to him, and that he will not supply such drug to any other investigator or to clinics for administration to human beings; and
   3. The establishment and maintenance of such records and the making of such reports to the board by the manufacturer or the sponsor of the investigation of such drugs of data including, but not limited to, analytical reports by investigators obtained as the result of such investigational use of such drug as the board finds will enable it to evaluate the safety and effectiveness of such drug in the event of the filing of an application pursuant to subdivision one of this section.
5. This section shall not apply to any drug which was licensed under the federal virus, serum, and toxin act of July first, nineteen hundred two (32 Stat. 728) or is licensed under section two hundred sixty-two of the public health service act of July first, nineteen hundred forty-four (58 Stat. 682), or under the federal virus, serums, toxins, antitoxins and analogous products act of March fourth, nineteen hundred thirteen (37 Stat. 832).

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