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Article 137, Pharmacist

Education Law

Article 137, Pharmacy

  1.  
    1. Each licensed pharmacist required under article one hundred thirty of this chapter to register triennially with the department to practice in the state shall comply with provisions of the mandatory continuing education requirements prescribed in subdivision two of this section except as set forth in paragraphs (b) and (c) of this subdivision. Pharmacists who do not satisfy the mandatory continuing education requirements shall not practice until they have met such requirements, and they have been issued a registration certificate, except that a pharmacist may practice without having met such requirements if he or she is issued a conditional registration certificate pursuant to subdivision three of this section.
    2. In accord with the intent of this section, adjustment to the mandatory continuing education requirement may be granted by the department for reasons of health certified by an appropriate health care professional, for extended active duty with the armed forces of the United States, or for other good cause acceptable to the department which may prevent compliance.
    3. A licensed pharmacist not engaged in practice as determined by the department, shall be exempt from the mandatory continuing education requirement upon the filing of a statement with the department declaring such status. Any licensee who returns to the practice of pharmacy during the triennial registration period shall notify the department prior to reentering the profession and shall meet such mandatory education requirements as shall be prescribed by regulations of the commissioner.
  2. *During each triennial registration period an applicant for registration shall complete a minimum of forty-five hours of acceptable formal continuing education, as specified in subdivision four of this section, provided that no more than twenty-two hours of such continuing education shall consist of self-study courses. Any pharmacist participating in collaborative drug therapy management pursuant to section six thousand eight hundred one-a of this article shall complete at least five hours of acceptable formal continuing education in the area or areas of practice generally related to any collaborative drug therapy management protocols to which the pharmacist may be subject. Any pharmacist whose first registration date following the effective date of this section occurs less than three years from such effective date, but on or after January first, nineteen hundred ninety-eight, shall complete continuing education hours on a prorated basis at the rate of one and one-quarter hours per month for the period beginning January first, nineteen hundred ninety-seven up to the first registration date thereafter. A licensee who has not satisfied the mandatory continuing education requirements shall not be issued a triennial registration certificate by the department and shall not practice unless and until a conditional registration certificate is issued as provided for in subdivision three of this section. Continuing education hours taken during one triennium may not be transferred to a subsequent triennium.
    * NB Effective until July 1, 2026
  1. *During each triennial registration period an applicant for registration shall complete a minimum of forty-five hours of acceptable formal continuing education, as specified in subdivision four of this section, provided that no more than twenty-two hours of such continuing education shall consist of self-study courses. Any pharmacist whose first registration date following the effective date of this section occurs less than three years from such effective date, but on or after January first, nineteen hundred ninety-eight, shall complete continuing education hours on a prorated basis at the rate of one and one-quarter hours per month for the period beginning January first, nineteen hundred ninety-seven up to the first registration date thereafter. A licensee who has not satisfied the mandatory continuing education requirements shall not be issued a triennial registration certificate by the department and shall not practice unless and until a conditional registration certificate is issued as provided for in subdivision three of this section. Continuing education hours taken during one triennium may not be transferred to a subsequent triennium.
    * NB Effective July 1, 2026
  2. The department, in its discretion, may issue a conditional registration to a licensee who fails to meet the continuing education requirements established in subdivision two of this section but who agrees to make up any deficiencies and complete any additional education which the department may require. The fee for such a conditional registration shall be the same as, and in addition to, the fee for the triennial registration. The duration of such conditional registration shall be determined by the department but shall not exceed one year. Any licensee who is notified of the denial of registration for failure to submit evidence, satisfactory to the department, of required continuing education and who practices pharmacy without such registration, may be subject to disciplinary proceedings pursuant to section sixty-five hundred ten of this chapter.
  3. As used in subdivision two of this section, "acceptable formal continuing education" shall mean formal courses of learning which contribute to professional practice in pharmacy and which meet the standards prescribed by regulations of the commissioner. The department may, in its discretion and as needed to contribute to the health and welfare of the public, require the completion of continuing education courses in specific subjects. To fulfill this mandatory continuing education requirement, courses must be taken from a sponsor approved by the department, pursuant to the regulations of the commissioner.
  4. Pharmacists shall maintain adequate documentation of completion of acceptable formal continuing education and shall provide such documentation at the request of the department. Failure to provide such documentation upon the request of the department shall be an act of misconduct subject to disciplinary proceedings pursuant to section sixty-five hundred ten of this chapter.
  5. The mandatory continuing education fee shall be forty-five dollars, shall be payable on or before the first day of each triennial registration period, and shall be paid in addition to the triennial registration fee required by section sixty-eight hundred five of this article.
  1. No pharmacist shall administer immunizing agents without a certificate of administration issued by the department pursuant to regulations of the commissioner.
  2. The fee for a certificate of administration shall be one hundred dollars and shall be paid on a triennial basis. A certificate may be suspended or revoked in the same manner as a license to practice pharmacy.
  1. For the purposes of this section, the following terms shall have the following meanings:
    1. "Covered pharmacy" means any pharmacy that is part of a group of eight or more pharmacies, located within New York state and owned by the same corporate entity. For purposes of this section, "corporate entity" shall include related subsidiaries, affiliates, successors, or assignees doing business as or operating under a common name or trading symbol.
    2. "Limited English proficient individual" or "LEP individual" means an individual who identifies as being, or is evidently, unable to speak, read or write English at a level that permits such individual to understand health-related and pharmaceutical information communicated in English.
    3. "Translation" shall mean the conversion of a written text from one language into an equivalent written text in another language by an individual competent to do so and utilizing all necessary pharmaceutical and health-related terminology. Such translation may occur, where appropriate, in a separate document provided to an LEP individual that accompanies his or her medication.
    4. "Competent oral interpretation" means oral communication in which a person acting as an interpreter comprehends a message and re-expresses that message accurately in another language, utilizing all necessary pharmaceutical and health-related terminology, so as to enable an LEP individual to receive all necessary information in the LEP individual's preferred pharmacy primary language.
    5. "Pharmacy primary languages" shall mean those languages spoken by one percent or more of the population, as determined by the U.S. Census, for each region, as established by regulations promulgated pursuant to this section, provided, however, that the regulations shall not require translation or competent oral interpretation of more than seven languages in any region.
    6. "Mail order pharmacy" shall mean a pharmacy that dispenses most of its prescriptions through the United States postal service or other delivery system.
  2.  
    1. Every covered pharmacy shall provide free, competent oral interpretation services and translation services to each LEP individual requesting such services or filling a prescription that indicates that the individual is limited English proficient at such covered pharmacy in the LEP individual's preferred pharmacy primary language for the purposes of counseling such individual about his or her prescription medications or when soliciting information necessary to maintain a patient medication profile, unless the LEP individual is offered and refuses such services.
    2. Every covered pharmacy shall provide free, competent oral interpretation services and translation services of prescription medication labels, warning labels and other written material to each LEP individual filling a prescription at such covered pharmacy, unless the LEP individual is offered and refuses such services or the medication label, warning labels and other written materials have already been translated into the language spoken by the LEP individual.
    3. The services required by this section may be provided by a staff member of the pharmacy or a third-party contractor. Such services must be provided on an immediate basis but need not be provided in-person or face-to-face in order to meet the requirements of this section.
  3. Every covered pharmacy shall conspicuously post, at or adjacent to each counter over which prescription drugs are sold, a notification of the right to free, competent oral interpretation services and translation services for limited English proficient individuals as provided for in subdivision two of this section. Such notifications shall be provided in the pharmacy primary languages. The size, style and placement of such notice shall be determined in accordance with rules promulgated pursuant to this section.
  4. The commissioner, in consultation with the commissioner of health, shall promulgate regulations requiring that mail order pharmacies conducting business in the state provide free, competent oral interpretation services and translation services to persons filling a prescription through such mail order pharmacies whom are identified as LEP individuals. Such regulations shall take effect one year after the effective date of this section; provided, however, that they shall be promulgated pursuant to the requirements of the state administrative procedure act, address the concerns of affected stakeholders, and reflect the findings of a thorough analysis of issues including:
    1. how persons shall be identified as an LEP individual, in light of the manner by which prescriptions are currently received by such mail order pharmacies;
    2. which languages shall be considered;
    3. the manner and circumstances in which competent oral interpretation services and translation services shall be provided;
    4. the information for which competent oral interpretation services and translation services shall be provided;
    5. anticipated utilization, available resources, and cost considerations; and
    6. standards for monitoring compliance with regulations and ensuring the delivery of quality competent oral interpretation services and translation services.
    The commissioner, in consultation with the commissioner of health, shall provide a report on implementation, utilization, unanticipated problems, and corrective actions undertaken and planned to the temporary president of the senate and the speaker of the assembly no later than two years after the effective date of this section.
  5. Covered pharmacies shall not be liable for injuries resulting from the actions of third-party contractors taken pursuant to and within the scope of the contract with the covered pharmacy as long as the covered pharmacy entered into such contract reasonably and in good faith to comply with this section, and was not negligent with regard to the alleged misconduct of the third-party contractor.
  6. The regulations promulgated pursuant to this section shall establish a process by which covered pharmacies may apply and receive a waiver from compliance with subdivisions two and three of this section upon a showing that implementation would be unnecessarily burdensome when compared to the need for such services.
  7. The commissioner shall promulgate regulations in consultation with the commissioner of health to effectuate the requirements of this section.
  1. The commissioner shall develop rules and regulations requiring standardized patient-centered data elements consistent with existing technology and equipment to be used on all prescription medicine dispensed to patients in this state.
  2. When developing the requirements for patient-centered data elements on prescription drug labels, the commissioner shall consider:
    1. medical literacy research that identifies factors that improve understandability of labels and promotes increased compliance with a drug's intended use;
    2. factors that improve the clarity of directions for use;
    3. font types and sizes;
    4. inclusion of only patient-centered information; and
    5. the needs of special populations.
    To ensure public input, the commissioner shall solicit input from the state board of pharmacy and the state board of medicine, consumer groups, advocates for special populations, pharmacists, physicians, other health care professionals authorized to prescribe, and other interested parties.
  1. Registration. Any outsourcing facility that is engaged in the compounding of sterile drugs in this state shall be registered as an outsourcing facility under the Federal Food, Drug and Cosmetic Act and be registered as an outsourcing facility pursuant to this article.
  2. New drugs. Sections 502(f)(1), 505 and 582 of the Federal Food, Drug and Cosmetic Act shall not apply to a drug compounded in an outsourcing facility registered under the Federal Food, Drug and Cosmetic Act.
  3. Prescriptions. 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.
  4. Restrictions. Any drugs compounded in an outsourcing facility registered pursuant to this article shall be compounded in accordance with all applicable federal and state laws.
  5. Labeling. Notwithstanding any other provision of law to the contrary, the label of any drug compounded by an outsourcing facility shall include, but not be limited to the following:
    1. a statement that the drug is a compounded drug or a reasonable comparable alternative statement that prominently identifies the drug as a compounded drug;
    2. the name, address, and phone number of the applicable outsourcing facility; and
    3. with respect to the drug:
      1. the lot or batch number;
      2. the established name of the drug;
      3. the dosage form and strength;
      4. the statement of quantity or volume, as appropriate;
      5. the date that the drug was compounded;
      6. the expiration date;
      7. storage and handling instructions;
      8. the National Drug Code number, if available;
      9. the statement that the drug is not for resale, and the statement "Office Use Only"; and
      10. a list of the active and inactive ingredients, identified by established name, and the quantity or proportion of each ingredient.
  6. Container. The container from which the individual units of the drug are removed for dispensing or for administration (such as a plastic bag containing individual product syringes) shall include:
    1. a list of active and inactive ingredients, identified by established name, and the quantity or proportion of each ingredient; and
    2. any other information required by regulations promulgated by the commissioner to facilitate adverse event reporting in accordance with the requirements established in section 310.305 of title 21 of the code of federal regulations.
  7. Bulk drugs. A drug may only be compounded in an outsourcing facility that does not compound using bulk drug substances as defined in section 207.3(a)(4) of title 21 of the code of federal regulations or any successor regulation unless:
    1. the bulk drug substance appears on a list established by the secretary of health and human services identifying bulk drug substances for which there is a clinical need;
    2. the drug is compounded from a bulk drug substance that appears on the federal drug shortage list in effect at the time of compounding, distributing, and dispensing;
    3. if an applicable monograph exists under the United States Pharmacopeia, the national formulary, or another compendium or pharmacopeia recognized by the secretary of health and human services and the bulk drug substances each comply with the monograph;
    4. the bulk drug substances are each manufactured by an establishment that is registered with the federal government.
  8. Ingredients. If an outsourcing facility uses ingredients, other than bulk drug substances, such ingredients must comply with the standards of the applicable United States pharmacopeia or national formulary monograph, if such monograph exists, or of another compendium or pharmacopeia recognized by the secretary of health and human services for purposes of this subdivision, if any.
  9. Unsafe or ineffective drugs. No outsourcing facility may compound a drug that appears on a list published by the secretary of health and human services that has been withdrawn or removed from the market because such drugs or components of such drugs have been found to be unsafe or not effective.
  10. Prohibition on wholesaling. No compounded drug will be sold or transferred by any entity other than the outsourcing facility that compounded such drug. This does not prohibit the administration of a drug in a health care setting or dispensing a drug pursuant to a properly executed prescription.
  11. Prohibition against copying an approved drug. No outsourcing facility may compound a drug that is essentially a copy of one or more approved drugs.
  12. Prohibition against compounding drugs presenting demonstrable difficulties. No outsourcing facility may compound a drug:
    1. that is identified, directly or as part of a category of drugs, on a list published by the secretary of health and human services that present demonstrable difficulties for compounding that are reasonably likely to lead to an adverse effect on the safety or effectiveness of the drug or category of drugs, taking into account the risks and benefits to patients; or
    2. that is compounded in accordance with all applicable conditions identified on the drug list as conditions that are necessary to prevent the drug or category of drugs from presenting demonstrable difficulties.
  13. Adverse event reports. Outsourcing facilities shall submit a copy of all adverse event reports submitted to the secretary of health and human services in accordance with the content and format requirements established in section 310.305 of title 21 of the code of federal regulations, or any successor regulation, to the executive secretary for the state board of pharmacy.
  14. Reports. The commissioner, in consultation with the commissioner of health, shall prepare and submit a report to the governor and the legislature, due eighteen months from the effective date of this section, evaluating the effectiveness of the registration and oversight of outsourcing facilities related to compounding.
  1. Subject to the limitations set forth in subdivision two of this section, an unlicensed person may assist a licensed pharmacist in the dispensing of drugs by:
    1. receiving written or electronically transmitted prescriptions, except that in the case of electronically transmitted prescriptions the licensed pharmacist or pharmacy intern shall review the prescription to determine whether in his or her professional judgment it shall be accepted by the pharmacy, and if accepted, the licensed pharmacist or pharmacy intern shall enter his or her initials into the records of the pharmacy;
    2. typing prescription labels;
    3. keying prescription data for entry into a computer-generated file or retrieving prescription data from the file, provided that such computer-generated file shall provide for verification of all information needed to fill the prescription by a licensed pharmacist prior to the dispensing of the prescription, meaning that the licensed pharmacist shall review and approve such information and enter his or her initials or other personal identifier into the recordkeeping system prior to the dispensing of the prescription or of the prescription refill;
    4. getting drugs from stock and returning them to stock;
    5. getting prescription files and other manual records from storage and locating prescriptions;
    6. counting dosage units of drugs;
    7. placing dosage units of drugs in appropriate containers;
    8. affixing the prescription label to the containers;
    9. preparing manual records of dispensing for the signature or initials of the licensed pharmacist;
    10. handing or delivering completed prescriptions to the patient or the person authorized to act on behalf of the patient and, in accordance with the relevant commissioner's regulations, advising the patient or person authorized to act on behalf of the patient of the availability of counseling to be conducted by the licensed pharmacist or pharmacy intern; and
    11. performing other functions as defined by the commissioner's regulations.
  2. Except for a licensed pharmacist employed by a facility licensed in accordance with article twenty-eight of the public health law or a pharmacy owned and operated by such a facility, as defined in article one hundred thirty-seven-A of this title, no licensed pharmacist shall obtain the assistance of more than four unlicensed persons, in the performance of the activities that do not require licensure, the total of such persons shall not exceed four individuals at any one time. Pharmacy interns shall be exempt from such ratios, but shall be supervised in accordance with the commissioner's regulations. Individuals who are responsible for the act of placing drugs which are in unit-dose packaging into medication carts as part of an approved unit-dose drug distribution system for patients in institutional settings shall be exempt from such ratio, provided that such individuals are not also engaged in performing the activities set forth in paragraph (b), (c), (d), (e), (f), (g), (h) or (i) of subdivision one of this section. The licensed pharmacist shall provide the degree of supervision of such persons as may be appropriate to ensure compliance with the relevant provisions of regulations of the commissioner.