Regulations of the Commissioner

Part 63, Pharmacy

Effective August 20, 2009

§63.1 Professional study of pharmacy | §63.2 Experience | §63.3 Licensing examinations | §63.4 Limited permits | §63.5 License as a pharmacist by endorsement | §63.6 Registration and operation of New York establishments | §63.7 Continuing education | §63.8 Registration of nonresident establishments | §63.9 Immunizations and emergency treatment of anaphylaxis pursuant to patient specific and non-patient specific orders and protocols | §63.10 Collaborative drug therapy management | §63.11 Interpretation and translation requirements for prescription drugs | §63.12 Standardized patient-centered data elements to be used on all drug labels

§63.1 Professional study of pharmacy.

  1. As used in this section, acceptable accrediting agency shall mean an organization accepted by the department as a reliable authority for the purpose of accreditation at the postsecondary level, applying its criteria for granting accreditation in a fair, consistent, and nondiscriminatory manner, such as an agency recognized for this purpose by the United States Department of Education.
  2. To meet the professional education requirement for admission to the licensing examination, the applicant shall present satisfactory evidence of either:
    1. completing a program in pharmacy leading to the baccalaureate degree, its equivalent, or a higher degree, that is either registered by the department pursuant to section 52.29 of this Title or accredited by an acceptable accrediting agency; or
    2. for applicants who apply for licensure prior to September 1, 2001, completing a nonregistered or nonaccredited program in pharmacy, including a foreign pharmacy program, of not less than three academic years of professional study, or the equivalent thereof, satisfactory to the department, and attaining Foreign Pharmacy Graduate Examination Committee Certification by the National Association of Boards of Pharmacy or its successor, or an equivalent certification acceptable to the department. The program of study in a foreign school of pharmacy shall culminate in the awarding of a degree, diploma or certificate in pharmacy recognized by the appropriate civil authorities of the country in which the school is located as meeting the educational requirement for entry into practice in that country; or
    3. for applicants who apply for licensure on or after September 1, 2001, completing a nonregistered or nonaccredited program in pharmacy, including a pharmacy program located in another country that is equivalent to a program registered by the department pursuant to section 52.29 of this Title and attaining Foreign Pharmacy Graduate Examination Committee Certification by the National Association of Boards of Pharmacy or its successor or an equivalent certification acceptable to the department. The program of study in another jurisdiction shall culminate in the awarding of a degree, diploma or certificate in pharmacy recognized by the appropriate civil authorities of the jurisdiction in which the school is located as meeting the educational requirements for entry into practice in that jurisdiction.
  3. A program of pharmacy education shall be considered completed upon certification of completion by the school in which such program was taken and proof that the applicant has been awarded the appropriate pharmacy degree, diploma or certificate.

§63.2 Experience.

For admission to the licensing examination:

  1. Graduates of registered or accredited programs leading to the bachelor's degree in pharmacy shall have completed at least six months of full-time experience, or the equivalent thereof, as a pharmacy intern in an internship program which meets the following requirements:
    1. Program requirement. The internship program shall be devoted to the preparing, compounding, preserving and dispensing of drugs, medicines and therapeutic devices and to the performance of the functions related thereto, such as the counseling of patients and the monitoring of drug regimens, under the supervision of a registered pharmacist.
    2. Time requirement. The six months shall be completed in accordance with the following:
      1. Any portion or all of the internship may be completed during periods subsequent to the successful completion of the first year of a professional education program in pharmacy and not concurrent with full-time enrollment in such a program.
      2. Any portion or all of the internship may be completed subsequent to the award of a degree in pharmacy which meets the requirement of section 63.1 of this Part.
      3. Part-time supervised practice completed pursuant to the provisions of subparagraphs (i) and (ii) of this paragraph may be granted proportionate credit. For the calculation of equivalencies, full-time shall be defined as 40 hours per week.
    3. Preceptor pharmacist requirement. The registered pharmacist who supervises an intern shall be designated the preceptor pharmacist. Each preceptor pharmacist shall have practiced for at least one year immediately preceding assuming a preceptorship. The preceptor pharmacist shall have under his or her supervision not more than one full-time intern nor more than two part-time interns.
    4. Additional requirement. In each pharmacy which will serve for the training of interns, one intern may be engaged for each 5,000 prescriptions and/or drug orders dispensed annually and for a major fraction thereof over a multiple of 5,000.
  2. Graduates of nonregistered and nonaccredited programs, including foreign programs in pharmacy, shall be authorized to begin an internship only after passing Part I of the pharmacist licensing examination. Thereafter, the applicant shall complete not less than 12 months of full-time experience, or the equivalent thereof, in an internship program which meets the requirements of paragraphs (a)(1), (3) and (4) of this section. Upon completion of the internship program, the applicant may be admitted to the practical portions (Part II and III) of the examination.
  3. Graduates of registered or accredited programs leading to the Doctor of Pharmacy degree shall be considered to have completed the internship requirement.

§63.3 Licensing examinations.

  1. Content. The examination shall consist of three parts:
    1. Applied chemistry, mathematics, pharmacology and pharmaceutics and clinical pharmacy.
    2. Professional law, ethics and professional conduct, prescription and nonprescription required drugs and prescription problems.
    3. Prescription compounding and pharmacy practice.
  2. Examination components.
    1. Part I of Examination. The department may accept satisfactory scores on an examination of the National Association of Boards of Pharmacy as meeting the requirements of Part I of the licensing examination.
    2. Alternative to Part III of Examination.
      1. The department may accept, as meeting the requirements of Part III of the licensing examination, certification that the applicant has successfully achieved each of the following competencies as part of a residency program in pharmacy practice approved by the department:
        1. sterile product preparation and technique;
        2. non-sterile compounding preparation and technique;
        3. performing dosing calculations, including but not limited to aliquot, proportions, and infusion drip-rates;
        4. medication safety procedures, including, but not limited to, identifying potential look-alike and sound-alike drugs and other medication error prevention techniques;
        5. drug distribution, including but not limited to preparing, dispensing and verifying the accuracy of filled prescriptions or medication orders; and
        6. such other competencies in pharmacy practice as may be required by the department.
      2. Such certification shall be on a form prescribed by the commissioner and shall be completed by the residency program director who supervised the applicant's performance in such residency program, attesting that the applicant has successfully achieved such competencies and that in the supervisor's judgment the applicant is competent to practice pharmacy.
  3. Passing score. The passing score in each part of the examination shall be 75.0, as determined by the State Board of Pharmacy.
  4. Special condition. A graduate of a registered or accredited program of education who has not completed the required practical experience may be admitted to Part I of the examination only.

§63.4 Limited permits.

  1. A limited permit, identifying the holder as a pharmacy intern and authorizing the practice of pharmacy under the immediate and personal supervision of a registered pharmacist, may be issued in accordance with the provisions of section 6806 of the Education Law to:
    1. an applicant, enrolled in a program of pharmacy education registered or approved by the department, who has completed at least the third year of a five-year program or its equivalent, provided that the applicant has completed the first year of professional study; or
    2. a graduate of a nonregistered or nonaccredited pharmacy program, including a foreign pharmacy program, for the purpose of completing the experience requirement set forth in section 63.2(b) of this Part.
  2. A limited permit shall be displayed conspicuously in the pharmacy where the pharmacy intern is engaged for supervised practice.
  3. A pharmacy intern may perform, under the supervision of a preceptor pharmacist, all of the functions delegated to pharmacists by law, rule or regulation.

§63.5 License as a pharmacist by endorsement.

For endorsement of a pharmacist license issued by another jurisdiction, the applicant shall:

  1. present evidence of having met all requirements of section 59.6 of this Title, except that the applicant shall have had, during the five years preceding the filing of the application, at least one year of satisfactory experience following licensure; and
  2. pass an examination of the laws, rules, regulations and professional conduct pertaining to the practice of pharmacy in New York administered by the department or an equivalent examination acceptable to the State Board of Pharmacy.

§63.6 Registration and operation of New York establishments.

  1. General Provisions.
    1. The requirements of this section shall apply to establishments located in New York State. Section 63.8 of this Part sets forth requirements for the registration of nonresident establishments.
    2. A certificate of registration issued for the operation of a pharmacy, manufacturer, outsourcing facility or wholesaler shall be valid only for that address stated on the certificate. Endorsement of the certificate to another address may be made by the State Board of Pharmacy upon application to the board, the payment of the fee set forth in Education Law, section 6808, and a finding by the board that the new location meets the requirements of the applicable subdivisions of this section. An application for endorsement to another address shall be made not less than 30 days prior to the expected date of relocation.
    3. In the case of a corporation, the State Board of Pharmacy shall be notified within 30 days of any change in the officers of the corporation or in stockholders holding 10 percent or more of the stock in the corporation.
    4. No certificate of registration shall be issued or continued for the conduct of a pharmacy, manufacturer, outsourcing facility or wholesaler unless the premises occupied by such registered establishment shall be equipped with proper sanitary appliances and kept in a clean and orderly manner.
    5. The State Board of Pharmacy shall be notified within a period of 48 hours whenever any establishment registered by the board is damaged by fire, flood or other disaster.
    6. Signs on establishments. Except as otherwise provided for pharmacies in general merchandising establishments in paragraph (b)(5) of this section, a sign bearing the full name of the registrant shall be displayed prominently on the exterior of the premises in which a registered establishment is located, or in the directory and on the immediate entrance to the registered establishment if it is located in a multi-tenanted structure.
    7. Electronic prescriptions.
      1. For the purposes of this section:
        1. the term electronic prescription means a prescription created, recorded, or stored by electronic means; issued and validated with an electronic signature; and transmitted by electronic means;
        2. the term electronic means of or relating to technology having electrical, digital, magnetic, wireless, optical, electromagnetic, or similar capabilities; and
        3. the term electronic signature means an electronic sound, symbol, or process, attached to or logically associated with an electronic prescription, executed or adopted by a person with the intent to sign the prescription, and effectively secured from alteration by an unauthorized third party.
      2. A pharmacist may, based upon his or her professional judgment, accept an electronic prescription from a prescriber, to the pharmacy of the patient's choice, subject to the following requirements:
        1. the prescription shall contain the electronic signature of the prescriber;
        2. in the case of an electronic prescription, such prescription shall be electronically encrypted, meaning protected to prevent access, alteration or use by any unauthorized person;
        3. an electronic prescription or a hard copy of an electronic prescription stored securely and permanently shall be maintained at the pharmacy for a period of five years from the date of the most recent filling, provided that, if the prescription is maintained electronically, it shall be made available to the Department in hard copy upon request;
        4. except when the prescriber inserts an electronic direction to dispense the drug as written, the prescriber’s electronic signature shall designate approval of substitution by a pharmacist of a drug product pursuant to section 206(1)(o) of the Public Health Law. Notwithstanding any other provision of this section or any other law to the contrary, 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 exists, which for purposes of this section shall be defined as a condition requiring the alleviation of severe pain or a condition which threatens to cause disability or death if not promptly treated, the pharmacist may dispense the brand name product at the regular price. In such instances, the pharmacist shall record the date, hour and nature of the medical emergency on the back of the prescription or within the electronic record of the prescription and shall keep a hard copy or electronic record of all such prescriptions;
        5. such prescriptions shall be processed in accordance with the requirements of section 29.7 of this title, provided, however, that prescriptions for controlled substances shall be filled in accordance with the requirements of Article 33 of the Public Health Law; and
        6. in accepting an electronic prescription, the pharmacist shall be subject to the applicable requirements of Part 29 of this Title relating to unprofessional conduct, including but not limited to section 29.1(b)(2) and (3) of this Title.
      3. 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, provided, however, that prescriptions for controlled substances shall be filled in accordance with the requirements of Article 33 of the Public Health Law. A permanent hard copy of a prescription transmitted by facsimile shall be stored securely and permanently in hard copy or by electronic means and shall be maintained at the pharmacy for a period of five years from the date of the most recent filling, provided that if the prescription is maintained electronically, it shall be made available to the Department in hard copy upon request.
    8. Refill transfers. Except for a prescription for a controlled substance under Article 33 of the Public Health Law, pharmacists at registered pharmacies may, at the express request and approval of a patient or a person authorized to act on behalf of the patient, transfer prescription information to, or accept a transfer from, another registered pharmacy or a pharmacy authorized to do business in another jurisdiction for the exclusive purpose of providing one authorized refill per transfer, subject to requirements of this paragraph.
      1. A pharmacist at a registered pharmacy may transfer original prescription information required by section 29.7 (a) (1) of this Title, to another pharmacy for the purpose of providing one authorized refill per transfer, provided that the original prescription information is transferred directly from one pharmacist to another pharmacist. Such transfer of prescription information may be accomplished by oral or written communication or by electronic transmission. The pharmacist at a registered pharmacy who transfers original prescription information shall record the following information:
        1. the fact that an authorized refill of the prescription has been transferred;
        2. the name, address and telephone number of the pharmacy to which it was transferred;
        3. the name of the pharmacist receiving the prescription information;
        4. the name of the pharmacist transferring the information; and
        5. the date of the transfer.
      2. A pharmacist at a registered pharmacy may accept the original prescription for the purpose of providing one authorized refill per transfer, provided that the original prescription information is transferred from one pharmacist to another pharmacist. The pharmacist at a registered pharmacy who accepts the original prescription information shall:
        1. obtain all information required by section 29.7(a)(1) of this Title;
        2. produce a hard copy of such information and ensure that the term "refill transfer" appears on the face of the hard copy; and
        3. record the dates of original and most recent filling or transfer of the original prescription, the transferring pharmacy's name and address, the original prescription number from which the prescription was transferred, the name of the pharmacist transferring the prescription, and the name of the pharmacist receiving the transfer.
      3. Systems providing for the electronic transfer of prescriptions shall not infringe on a patient's freedom of choice as to the provider of pharmaceutical care.
      4. The hard copy of the transferred prescription shall be maintained for a period of five years from the date of filling.
      5. A pharmacy utilizing automated data processing systems to transfer a prescription refill or to accept a prescription refill shall satisfy the requirements of this subdivision and shall also meet the requirements of paragraph (9) of this subdivision if the pharmacy accesses a common electronic file or database used to maintain required personally identifiable dispensing information.
    9. A pharmacy that accesses a common electronic file or database used to maintain required personally identifiable dispensing information shall only access such information upon the express request of the patient or a person authorized to act on behalf of the patient. Such common file shall contain complete records of each prescription and refill dispensed.
  2. Pharmacies.
    1. To secure and retain registration, a pharmacy shall be equipped with at least the following utensils:
      1. weighing device sensitive to 6 mg;
      2. metric weights, if needed for the operation of the device in subparagraph (i) of this paragraph;
      3. devices capable of measuring volumes from 0.1 ml to 500 ml; and
      4. a mortar and pestle.
    2. The registered area shall measure not less than 300 square feet and shall include a manufacturing, compounding and dispensing area of not less than 100 square feet. The pharmacy shall be equipped with storage facilities providing for the safe storage of drugs; with heating and ventilation adequate to safeguard the purity and potency of drugs; with adequate lighting; and with hot and cold running water in the compounding and dispensing area; provided, however, that a pharmacy which was registered initially prior to the effective date of this paragraph on the basis of meeting requirements less than those specified in this paragraph shall not be required to meet the requirements of this paragraph for the continuance of registration to the same registrant.
    3. The registered area shall include a refrigerator, sufficient in capacity to serve the needs of the pharmacy, that is equipped with a thermometer and providing at all times a storage temperature of 2 degrees to 8 degrees Centigrade (36 degrees to 46 degrees Fahrenheit). The use of such refrigerator shall be limited to the storage of drugs.
    4. The pharmacy shall possess copies of laws, rules and regulations governing the practice of pharmacy in New York, and other reference resources as may be necessary to carry on the practice.
    5. A pharmacy operated as a department of a general merchandising establishment shall be enclosed permanently by a partition at least nine feet six inches in height, except where the ceiling is less than nine feet six inches in height in which case the partition shall be from floor to ceiling. Identification of such department by use of words "drugs," "medicines," "drug store" or "pharmacy" or similar terms shall be restricted to the area registered by the department, except that nothing in this restriction shall prevent the placement on the exterior of such establishment of signs indicating the existence of a pharmacy therein. Such exterior signs may consist of the name of the registrant and/or the word pharmacy; provided, however, that when the word pharmacy is used, it may not be used in juxtaposition to a nonregistered name. When the pharmacy is not open during all the hours maintained by the general merchandising establishment, an exterior sign shall indicate clearly when the pharmacy is open and when it is closed.
    6. A pharmacy in which radioactive drugs are dispensed shall meet all requirements established by 10 NYCRR Part 16 for medical and academic facilities or by 12 NYCRR Part 38 for commercial facilities as evidenced by receipt by the pharmacy of an appropriate license issued by the New York State Department of Health or the New York State Department of Labor, and the additional requirements which follow.
      1. There shall be present at all hours when the pharmacy is open at least one pharmacist who:
        1. meets the minimal standards of training and experience required by 10 NYCRR Part 16 or by 12 NYCRR Part 38 for the use of radioactive materials; and
        2. has submitted to the State Board of Pharmacy evidence of either of the following:
          1. certification as a Nuclear Pharmacist by the Board of Pharmaceutical Specialties of the American Pharmaceutical Association; or
          2. completion of a minimum of 200 contact hours of didactic instruction in nuclear pharmacy in an accredited school or college of pharmacy, and a minimum of 500 hours of clinical nuclear pharmacy training under the supervision of a Board of Pharmaceutical Specialties certified nuclear pharmacist in a pharmacy providing nuclear pharmacy services, in a certified nuclear pharmacy residency program or in a nuclear pharmacy training program in an accredited school or college of pharmacy or the equivalent thereof as determined by the department.
      2. In addition to the items and articles of equipment required by this subdivision, the pharmacy shall be equipped with at least the following:
        1. laminar flow hood;
        2. dose calibrator;
        3. exhaust hood and filter system;
        4. chromatography apparatus;
        5. apparatus or materials for the determination of pH;
        6. single-channel and/or multichannel scintillation detection system; and
        7. microscope.
      3. A pharmacy which dispenses both radioactive drugs and nonradioactive drugs shall maintain a separate area for the storage and dispensing of radioactive drugs, which area shall be secured from unauthorized personnel.
    7. Patient medication profile. Each pharmacist shall maintain a patient medication profile. Such medication profile shall include, but not be limited to, the patient's name, address, telephone number, gender, date of birth or age, known allergies and drug reactions, chronic diseases, a comprehensive list of medications and relevant devices and other information reported to the pharmacist appropriate for counseling an individual regarding use of prescription and over-the-counter drugs. Pharmacists or pharmacy interns shall conduct a prospective drug review before each prescription is dispensed or delivered to a patient or person authorized to act on behalf of the patient. Such review shall include screening for potential drug therapy problems due to therapeutic duplication, drug-drug interactions, including serious interactions with over-the-counter drugs, incorrect drug dosage or duration of drug treatment, drug-allergy interactions, and clinical abuse or misuse. Patient medication profiles shall be maintained in a retrievable form for five years following the date of the most recent entry.
    8. Counseling.
      1. On-premises delivery. For a prescription that is delivered to a patient or a person authorized to act on behalf of the patient on the premises of the pharmacy, the pharmacist or pharmacy intern shall meet the requirements of this subparagraph. For a prescription that is delivered to a patient or a person authorized to act on behalf of a patient off the premises of a pharmacy through mail delivery, a delivery service or otherwise, the pharmacist or pharmacy intern shall meet the requirements of subparagraph (ii) of this paragraph.
        1. Prior to dispensing a prescription for the first time for a new patient of the pharmacy or a prescription for a new medication for an existing patient of the pharmacy and/or a change in the dose, strength, route of administration or directions for use of an existing prescription previously dispensed for an existing patient of the pharmacy, a pharmacist or pharmacy intern providing prescription services shall be required to personally counsel each patient or person authorized to act on behalf of a patient who presents a prescription, consistent with the provisions of section 29.1(b)(8) of this Title, in person in a face-to-face meeting whenever practicable, or by telephone, matters which in the exercise of the pharmacist's or pharmacy intern's professional judgment, the pharmacist or pharmacy intern deems appropriate, which may include:
          1. the name and description of the medication and known indications;
          2. dosage form, dosage, route of administration and duration of drug therapy;
          3. special directions and precautions for preparation, administration and use by the patient;
          4. common severe side or adverse effects or interactions and therapeutic contraindications that may be encountered, including their avoidance, and the action required if they occur;
          5. techniques for self-monitoring drug therapy;
          6. proper storage;
          7. prescription refill information; and
          8. action to be taken in the event of a missed dose.
        2. The counseling of a patient or person authorized to act on behalf of a patient pursuant to clause (a) of this subparagraph shall be provided personally by the pharmacist or the pharmacy intern and shall not be delegated to an individual not authorized to practice pharmacy under a license or limited permit.
        3. In the event a patient refuses to supply information necessary for maintenance of a medication profile, or to accept counseling, as prescribed in clause (a) of this subparagraph, a pharmacist or pharmacy intern may fill a prescription as presented, without having violated the requirements of this subparagraph, provided that the refusal to provide such information or accept counseling is documented in the records of the pharmacy.
        4. In the event a patient or a person authorized to act on behalf of a patient seeks to obtain a refill of an existing prescription previously filled by the pharmacy or an authorization for continuation of an existing therapy, a pharmacist or pharmacy intern shall be available to provide counseling to the patient or person authorized to act on behalf of a patient, upon such person's request. In such circumstances and consistent with the requirements of paragraph (21) of subdivision (a) of section 29.7 of this Title, an offer to counsel the patient or a person authorized to act on behalf of a patient may be conveyed on behalf of the pharmacist or pharmacy intern by an unlicensed assistant. Such counseling shall be conducted only by a pharmacist or pharmacy intern.
        5. Nothing in this subparagraph shall prevent a pharmacist or pharmacy intern from refusing to dispense a prescription if, in his or her professional judgment, potential adverse effects, interactions or other therapeutic complications could endanger the health of the patient.
      2. Off-premises delivery. For a prescription that is delivered to the patient or the person authorized to act on behalf of the patient off the premises of the pharmacy through mail delivery, a delivery service or otherwise, the pharmacist or pharmacy intern shall meet the requirements of this subparagraph.
        1. Upon dispensing a prescription, a pharmacist or pharmacy intern shall include with each prescription a written offer to counsel the patient or person authorized to act on behalf of the patient who presents the prescription. The written offer of counseling shall advise the patient or the person authorized to act on behalf of the patient of the availability of counseling on topics, which shall include but not be limited to, the topics listed in subclauses (1) through (8) of clause (a) of subparagraph (i) of this paragraph and that a licensed pharmacist or pharmacy intern authorized to practice pharmacy is available to provide the counseling. The written offer to counsel shall provide a telephone number at which a licensed pharmacist or pharmacy intern may be readily reached. For pharmacies engaged primarily in the mail order delivery of prescriptions, that telephone number shall be toll-free for long distance calls.
        2. When a patient or person authorized to act on behalf of the patient requests counseling pursuant to the written offer of counseling, the pharmacist or pharmacy intern shall personally counsel that person, consistent with the provisions of section 29.1(b)(8) of this Title, to the extent the pharmacist or pharmacy intern deems appropriate in his or her professional judgment. Such counseling may include the topics listed in subclauses (1) through (8) of clause (a) of subparagraph (I) of this paragraph. Such counseling shall be conducted via telephone or in an in-person face-to-face meeting.
        3. Except for instances covered by clause (d) of this subparagraph, which applies in those cases, if upon presentation of the prescription, the pharmacist or pharmacy intern determines that the prescription is a prescriber approved alternative drug, meaning a change in the drug originally prescribed exclusive of generic substitutions, the pharmacist or pharmacy intern shall meet the following requirements in addition to the requirements of clauses (a) and (b) of this subparagraph:
          1. Upon dispensing the prescription, the pharmacist or pharmacy intern shall include with each prescription a special written notification that clearly advises the patient or the person authorized to act on behalf of the patient that a prescriber approved alternative drug has been dispensed, the directions for the use of such drug and the availability of counseling on the drug.
          2. Except for the cases set forth in subclause (3) of this clause, the pharmacist or pharmacy intern shall make a reasonable effort to contact the patient or person authorized to act on behalf of the patient by telephone in order to personally offer counseling to that person about the prescriber approved alternative drug and other matters which in the exercise of the pharmacist's or pharmacy intern's judgment, he or she deems appropriate, consistent with the provisions of section 29.1(b)(8) of this Title, including topics prescribed in subclauses (1) through (8) of clause (a) of subparagraph (i) of this paragraph. The effort to contact the patient or person authorized to act on behalf of the patient by telephone may commence after the drug is mailed or delivered to that person. A reasonable effort to contact the patient or the person authorized to act on behalf of the patient by telephone shall mean at least two attempts to reach the patient or person authorized to act on behalf of the patient through telephone calls placed to such person by 48 hours after mailing or delivering the prescription.
          3. The pharmacist or pharmacy intern shall not be required to make an effort to contact the patient or the person authorized to act on behalf of the patient by telephone, as prescribed in subclause (2) of this clause, if the patient or the person authorized to act on behalf of the patient does not have a telephone at which he or she may be reached, or if such person refuses to provide a telephone number at which he or she may be reached, or if such person has indicated to the pharmacy that he or she does not wish to be contacted by telephone for counseling.
          4. The pharmacy shall document the efforts made to contact the patient or the person authorized to act on behalf of the patient by telephone, or alternatively, the fact that the patient or person authorized to act on behalf of the patient either does not have a telephone at which he or she may be reached or refuses to provide a telephone number at which he or she may be reached or has indicated to the pharmacy that he or she does not wish to be contacted by telephone for counseling.
          5. The offer to counsel the patient or the person authorized to act on behalf of the patient shall be provided personally by the pharmacist or the pharmacy intern and shall not be delegated to an individual not authorized to practice pharmacy under a license or limited permit.
          6. If the offer of counseling is accepted, the pharmacist or pharmacy intern shall counsel the patient or the person authorized to act on behalf of the patient to the extent that the pharmacist or pharmacy intern deems appropriate in his or her professional judgment, as prescribed in subclause (2) of this clause.
          7. If the offer of counseling is not accepted, the refusal to accept counseling shall be documented in the records of the pharmacy.
        4. If upon presentation of the prescription, the pharmacist of pharmacy intern determines that there are potential drug therapy problems which could endanger the health of the patient, including but not limited to: therapeutic duplication, drug-drug interactions and drug-allergy interactions, the pharmacist or pharmacy intern shall be subject to the following requirements in addition to the requirements of clauses (a) and (b) of this subparagraph:
          1. Prior to dispensing the prescription, the pharmacist or pharmacy intern shall personally contact the patient or person authorized to act on behalf of the patient via telephone or through an in-person face-to-face meeting to offer counseling on the identified potential drug therapy problems and other matters which in the exercise of the pharmacist's or pharmacy intern's judgment, he or she deems appropriate, consistent with the provisions of section 29.1(b)(8) of this Title, including topics prescribed in subclauses (1) through (8) of clause (a) of subparagraph (i) of this paragraph.
          2. The offer to counsel the patient or the person authorized to act on behalf of the patient shall be provided personally by the pharmacist or the pharmacy intern and shall not be delegated to an individual not authorized to practice pharmacy under a license or limited permit.
          3. If the offer of counseling is accepted, the pharmacist or pharmacy intern shall counsel the patient or the person authorized to act on behalf of the patient to the extent that the pharmacist or pharmacy intern deems appropriate in his or her professional judgment, as prescribed in subclause (1) of this clause.
          4. If the offer of counseling is not accepted, the refusal to accept counseling shall be documented in the records of the pharmacy.
          5. Nothing in this subparagraph shall prevent a pharmacist or pharmacy intern from refusing to dispense a prescription if, in his or her professional judgment, potential adverse effects, interactions or other therapeutic complications could endanger the health of the patient.
    9. Drug retail price lists.
      Every registered pharmacy that sells prescription medications at retail shall meet the requirements of section 6826 of the Education Law. In accordance with subdivision (4) of section 6826 of the Education Law, such registered pharmacies shall have a sign notifying people of the availability of the drug retail price list, conspicuously posted at or adjacent to the place in the pharmacy where prescriptions are presented for compounding and dispensing, in the waiting area for customers, or in the area where prescribed drugs are delivered. The sign shall state in bold, block letters of at least one inch in height: "Drug Retail Price List Available Upon Request". Such registered pharmacies that offer to dispense prescription drugs to consumers through a website on the Internet shall post on such website a notice of the availability of the drug retail price list. Such registered pharmacies that offer to dispense prescription drugs to consumers through mail order shall include a printed notice with each delivery of a prescription drug informing the consumer of the availability of the drug retail price list and a toll-free telephone number to obtain the list.

  3. Manufacturers, outsourcing facilities and wholesalers.
    1. Except as provided in paragraph (2) of this subdivision, no manufacturer or wholesaler shall be registered pursuant to the provisions of subdivision 4 of section 6808 of the Education Law Law and no outsourcing facility shall be registered pursuant to the provisions of subdivision 5 of section 6808 of the Education Law unless a registered pharmacist is present at all times when the establishment is open for business; provided, however, that establishments registered as a manufacturer or wholesaler under this section may be under the supervision of an individual who has at least two years of experience in the manufacturing, repacking and/or wholesaling of drugs satisfactory to the department and is either:
      1. a chemist who holds a bachelor’s degree in chemistry; or
      2. an individual who holds a bachelor’s degree in pharmaceutical manufacturing, biochemistry, microbiology or other bachelor’s degree deemed satisfactory to the Department.
    2. Wholesalers who do not repack may designate as the supervisor a person who presents evidence of the completion of a minimum of two years of education beyond high school and who has at least two years of experience in the manufacturing, repacking and/or wholesaling of drugs satisfactory to the State Board of Pharmacy. Establishments which limit their operation to manufacturing and repacking of compressed medical gases and/or wholesaling of related respiratory therapy agents may be under the supervision of:
      1. a respiratory therapist certified by a national accrediting body;
      2. a person holding a bachelor's degree in chemistry, microbiology, chemical engineering or a related field; or
      3. a person having two years of education beyond high school and two years experience in the handling of compressed medical gases satisfactory to the State Board of Pharmacy.
    3. The supervisor of an establishment designated pursuant to paragraphs (1) and (2) of this subdivision shall not be at the same time the supervisor of any other establishment registered by the board.
    4. The size and facilities of a registered establishment shall be appropriate for the activities to be conducted therein. The area to be registered shall measure not less than 300 square feet. The registered area shall not be shared with or be devoted in part to any other business. The registered establishment shall be in compliance with at least the minimum requirements as provided in section 205.50 of title 21 of the Code of Federal Regulations (Code of Federal Regulations, 1991 edition, Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402: 1991--available at New York State Board of Pharmacy, Room 3035, Cultural Education Center, Albany, NY 12230.
    5. Manufacturers, outsourcing facilities or wholesalers shall sell drugs and/or devices only to those purchasers authorized by law. Records of the receipt and disposition of all drugs and/or devices shall be maintained for a period of five years and shall be available to the department for review and copying upon request.
    6. Certification of manufacturers and wholesalers for export purposes. Any registered manufacturer or wholesaler may be issued a certificate by the executive secretary of the State Board of Pharmacy, authenticating said registration and identifying the specified drugs and/or devices as articles regularly offered for sale in New York. The fee for each certificate shall be $5.
    7. Additional requirements for outsourcing facilities.
      1. 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, on a form prescribed by the Commissioner, which shall include, but not be limited to:
        1. identification of the drugs compounded by such outsourcing facility during the previous six-month period; and
        2. with respect to each such identified drug, provide 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 individuals units produced; and the national drug code number of the final product, if assigned.
      2. Outsourcing facilities shall maintain quality control records for determining beyond use dating and stability for five years and shall make such records available to the department for review and copying upon request.
      3. Outsourcing facilities shall comply with the special provisions relating to outsourcing facilities set forth in Education Law section 6831.
      4. Outsourcing facilities shall comply with current good manufacturing practices as specified in parts 210 and 211 of title 21, Code of Federal Regulations (2013 edition, Superintendent of Documents, U.S. Government Printing Office, Washington DC 20402; 2013, available at New York State Board of Pharmacy, 2nd Floor, Education Building, 89 Washington Avenue, Albany, New York 12234).
      5. At all times such facilities shall be under the supervision of a pharmacist licensed and registered to practice pharmacy in New York State.
      6. Upon initial registration and at each renewal, such facilities shall submit to the department documentation that the facility is registered as an outsourcing facility under the Federal Food, Drug and Cosmetic Act.
      7. Upon initial registration and at least annually thereafter, such facilities shall submit to the department the results of an inspection by either: representatives of the Federal Food and Drug Administration, this department or a third party acceptable to the department.
      8. No outsourcing facility may distribute or dispense any drug to any person pursuant to a prescription unless it is also a New York State registered pharmacy and meets all other applicable requirements of federal and State law.
      9. Outsourcing facilities that fail to demonstrate that the facility is registered as an outsourcing facility under the Federal Food, Drug and Cosmetic Act shall not meet the requirements for renewal of registration.
  4. The Commissioner, upon recommendation of the Board of Pharmacy, may in his or her discretion waive regulations in this Part in order to allow the initiation and evaluation of demonstration projects using emerging technologies and practices in the profession of pharmacy, if the Commissioner determines that such waiver does not violate a statutory requirement or a Rule of the Board of Regents, is consistent with existing statutory and regulatory intent, and that such waiver will not diminish patient safety or consumer protections.

§63.7 Continuing education.

  1. As used in this section, acceptable accrediting agency shall mean an organization accepted by the department as a reliable authority for the purpose of accreditation at the postsecondary level, applying its criteria for granting accreditation in a fair, consistent, and nondiscriminatory manner, such as an agency recognized for this purpose by the United States Department of Education.
  2. Applicability of requirement.
    1. Each licensed pharmacist, required under article 130 of the Education Law to register with the department to practice in New York State, shall comply with the mandatory continuing education requirements as prescribed in subdivision (c) of this section, except those licensees exempt from the requirement or who obtain an adjustment to the requirement pursuant to paragraph (2) of this subdivision.
    2. Exemptions and adjustments to the requirement.
      1. Exemption. Licensees who are not engaged in the practice of pharmacy, as evidenced by not being registered to practice in New York State, except as otherwise provided in paragraph (c)(2) of this section to meet the education requirements for the resumption of practice after a lapse in practice for a licensee who has not lawfully practiced continuously in another jurisdiction throughout such lapse period.
      2. Adjustments to the requirement. An adjustment to the continuing education requirement, as prescribed in subdivision (c) of this section, shall be made by the department, provided that the licensee documents good cause that prevents compliance, which shall include but not be limited to, any of the following reasons: poor health certified by an appropriate health care professional; or extended active duty with the Armed Forces of the United States; or extreme hardship which in the judgment of the department makes it impossible for the licensee to comply with the continuing education requirements in a timely manner.
  3. Mandatory continuing education requirement.
    1. During each triennial registration period, meaning a registration period of three years' duration, an applicant for registration shall complete at least 45 hours of formal continuing education acceptable to the department, as defined in paragraph (4) of this subdivision, provided that no more than 22 hours of such continuing education shall consist of self-study courses. During registration periods beginning on or after September 1, 2003, a licensee shall complete as part of the 45 hours of formal continuing education, or pro-ration thereof, at least three hours of formal continuing education acceptable to the department in the processes and strategies that may be used to reduce medication and/or prescription errors. Any licensee participating in collaborative drug therpay management pursuant to Education Law section 6801-a, shall complete as part of the 45 hours of formal continuing education, or pro-ration therof, at least five hours of formal continuing education acceptable to the department in the area or areas of practice generally related to any collaborative drug therapy management protocols to which the pharmacist may be subject, provided that such continuing education shall not be completed as self-study.
    2. Requirement for lapse in practice.
      1. A licensee returning to the practice of pharmacy after a lapse in practice, as evidenced by not being registered to practice in New York State, whose first registration date after such lapse in practice and following January 1, 1997 occurs less than three years from January 1, 1997, but on or after January 1, 1998, shall be required to complete:
        1. at least one and one-quarter hours of acceptable formal continuing education for each month beginning with January 1, 1997 until the beginning of the new registration period, which shall be completed for a licensee who has not lawfully practiced pharmacy continuously in another jurisdiction throughout such lapse period, in the 12-month period before the beginning of the new registration period; and for a licensee who has lawfully practiced pharmacy continuously in another jurisdiction throughout such lapse period, in the new registration period or at the option of the licensee in the period beginning 36 months before the commencement of the new registration period and ending at the conclusion of such registration period; and
        2. for a licensee who has not lawfully practiced pharmacy continuously in another jurisdiction throughout such lapse period, at least 15 hours of acceptable formal continuing education in each successive 12-month period of the new registration period; and for a licensee who has lawfully practiced pharmacy continuously in another jurisdiction throughout such lapse period, acceptable formal continuing education at the rate of one and one-quarter hours per month during the new registration period.
      2. Except as prescribed in subparagraph (i) of this paragraph for registrations therein specified, the licensee who returns to the practice of pharmacy after a lapse in practice in which the licensee was not registered to practice in New York State and did not lawfully practice pharmacy continuously in another jurisdiction throughout the lapse period, shall be required to complete:
        1. the continuing education requirement applicable to the period of time the licensee was registered in the licensee's last registration period;
        2. at least one and one-quarter hours of acceptable formal continuing education for each month of lapsed registration up to a maximum of 45 hours, which shall be completed in the 12 months before the beginning of the new registration period; and
        3. at least 15 hours of acceptable formal continuing education in each succeeding 12-month period, after such registration is reissued, until the next registration date.
      3. Except as prescribed in subparagraph (i) of this paragraph for registrations therein specified, the licensee who returns to the practice of pharmacy after a lapse in practice in which the licensee was not registered to practice in New York State but did lawfully practice pharmacy continuously in another jurisdiction throughout the lapse period, shall be required to complete:
        1. the continuing education requirement applicable to the period of time the licensee was registered in the licensee's last registration period;
        2. at least one and one-quarter hours of acceptable formal continuing education for each month of lapsed registration up to a maximum of 45 hours, which shall be completed in the new registration period, or at the option of the licensee in the period beginning 36 months before the commencement of the new registration period and ending at the conclusion of the new registration period; and
        3. completion of the regular continuing education requirement at the rate of one and one-quarter hours of acceptable formal continuing education per month during the new registration period.
    3. Proration. If a registration period is less than three years in duration, a licensed pharmacist shall complete acceptable formal continuing education at the rate of one and one-quarter hours of continuing education per month for such registration period.
    4. To be acceptable to the department, formal continuing education shall be formal courses of learning which contribute to professional practice in pharmacy:
      1. in any one or more of the following curricular areas: pharmacology of new and developing drugs, or drug interactions, or public health issues, or infection control, or sterile procedures, or legal and regulatory issues, or patient counseling, or other topics which contribute to the professional practice in pharmacy as such practice is defined in section 6801 of the Education Law, or other matters of health care, law, and ethics which contribute to the health and welfare of the public; and
      2. obtained from a sponsor approved by the department pursuant to subdivision (h) of this section.
  4. Renewal of registration. At each reregistration, licensed pharmacists shall certify to the department that they have either complied with the continuing education requirements, as prescribed in subdivision (c) of this section; or are subject to an exemption or adjustment to such continuing education requirements, as prescribed in subdivision (b) of this section.
  5. Conditional registration.
    1. The department shall issue a conditional registration to a licensee who attests to or admits to noncompliance with the continuing education requirements of this section, provided that such licensee meets the following requirements:
      1. the licensee agrees to remedy such deficiency within the conditional registration period;
      2. the licensee agrees to complete the regular continuing education requirement at the rate of one and one-quarter hours of acceptable formal continuing education per month during such conditional registration period; and
      3. the licensee agrees to complete additional continuing education during such conditional registration period, which the department may require to ensure the licensee's proper delivery of pharmaceutical care consistent with the licensee's practice of pharmacy.
    2. The duration of such conditional registration shall not exceed one year and shall not be renewed or extended.
  6. Licensee records. Each licensee subject to this section shall maintain, or ensure access by the department to, a record of completed continuing education which includes: the title of the program, the number of hours completed, the sponsor's name and any identifying number, attendance verification, and the date and location of the program. Such records shall be retained for at least six years from the date of completion of the program and shall be available for review by the department in the administration of the requirements of this section.
  7. Measurement of continuing education study. Continuing education credit shall be granted only for formal programs of learning that meet the requirements set forth in subdivision (c) of this section. A minimum of 50 minutes of study shall equal one hour of continuing education credit. For credit-bearing university or college courses, each semester-hour of credit shall equal 15 hours of continuing education credit, and each quarter-hour of credit shall equal 10 hours of continuing education credit.
  8. Sponsor approval.
    1. To be approved by the department, sponsors of continuing education to licensed pharmacists shall meet the requirements of either paragraph (2) or (3) of this subdivision.
    2. The department shall deem approved as a sponsor of continuing education to licensed pharmacists:
      1. a sponsor of continuing education that is approved by the American Council on Pharmaceutical Education or an equivalent organization determined by the State Board for Pharmacy to have equivalent standards for approving sponsors of continuing education for professionals regulated by title VIII of the Education Law; or
      2. a postsecondary institution for courses in programs that are registered pursuant to Part 52 of this Title or in equivalent programs that are accredited by an acceptable accrediting agency.
    3. Department review of sponsors.
      1. The department shall conduct a review of sponsors that apply for approval to offer continuing education to licensed pharmacists and that are not deemed approved pursuant to the requirements of paragraph (2) of this subdivision
      2. Organizations desiring to offer continuing education based upon a department review under this paragraph shall submit, with the fee as set forth in subdivision (i) of this section, an application for advance approval as a sponsor at least 90 days prior to the date for the commencement of such continuing education that documents that the organization:
        1. will offer courses of study in any one or more of the following curricular areas: pharmacology of new and developing drugs, or drug interactions, or public health issues,
          or infection control, or sterile procedures, or legal and regulatory issues, or patient counseling, or other topics which contribute to the professional practice in pharmacy as such practice is defined in section 6801 of the Education Law, or other matters of health care, law, and ethics which contribute to the health and welfare of the public;
        2. is an organized educational entity, including but not limited to, a college of pharmacy; or a national, State, or local pharmacy association; or a hospital or health maintenance organization;
        3. provides course instructors who are qualified to teach the courses which will be offered, including but not limited to, faculty of a college of pharmacy accredited by an acceptable accrediting agency; or instructors who are authorities in the health sciences specially qualified, in the opinion of the State Board of Pharmacy, to conduct such courses;
        4. has a method of assessing the learning of participants, and describes such method; and
        5. will maintain records for at least six years from the date of completion of coursework, which shall include, but shall not be limited to, the name and curriculum vitae of the faculty, a record of attendance of licensed pharmacists in such course work, an outline of the course of instruction, date and location of the coursework, and the number of hours for completion of the coursework. In the event an approved sponsor discontinues operation, the governing body of such sponsor shall notify the department and shall transfer all such records as directed by the department.
      3. Sponsors that are approved by the department pursuant to the requirements of this paragraph shall be approved for a three-year term.
      4. The department may conduct site visits of or request information from a sponsor approved pursuant to the requirements of this paragraph to ensure compliance with such requirements, and a sponsor shall cooperate with the department in permitting such site visits and in providing such information.
      5. A determination by the department that a sponsor approved pursuant to the requirements of this paragraph is not meeting the standards set forth in this paragraph shall result in the denial or termination of the approved status of the sponsor.
  9. Fees.
    1. At the beginning of each registration period, a mandatory continuing education fee of $45 shall be collected from licensees engaged in the practice of pharmacy in New York State, except for those exempt from the requirement pursuant to subparagraph (b)(2)(i) of this section. This fee shall be in addition to the registration fee required by section 6805 of the Education Law.
    2. Licensees applying for a conditional registration, pursuant to the requirements of subdivision (e) of this section, shall pay a fee that is the same as and in addition to, the fee for the triennial registration required by section 6805 of the Education Law. In addition, such licensees shall pay the $45 mandatory continuing education fee.
    3. Organizations desiring to offer continuing education to licensed pharmacists based upon a department review, pursuant to paragraph (h)(3) of this section, shall submit an application fee of $900 with its application for the issuance of a permit from the department to become an approved sponsor of a formal continuing education program. Application for a three-year renewal of the permit shall be accompanied by a fee of $900.

§63.8 Registration of nonresident establishments.

  1. Definitions. For purposes of this section and section 6808-b of the Education Law:
    1. Nonresident establishment means any pharmacy, manufacturer, outsourcing facility or wholesaler located outside of New York State that ships, mails or delivers prescription drugs or devices to other establishments, authorized prescribers and/or patients residing in New York State. Such establishments shall include, but not be limited to, pharmacies that transact business through the use of the internet.
    2. Isolated transaction means for pharmacies, only, 600 or fewer prescriptions per calendar year for drugs and/or other devices delivered into New York State, and for manufacturers and wholesalers, sales that total less than $10,000 in value, at wholesale per calendar year, for drugs and/or devices delivered into New York State, except that upon application by a nonresident pharmacy, manufacturer or wholesaler, the department may deem a transaction to be an isolated transaction, when such transaction is necessary to protect the public health by addressing a temporary emergency shortage of a prescription drug and/or device in New York State.
  2. Registration requirements.
    1. All nonresident establishments that ship, mail, or deliver prescription drugs and/or devices to other registered establishments, authorized prescribers, and/or patients into New York State shall be registered with the department in accordance with this section and section 6808-b of the Education Law, 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, and except that such registration shall not apply to nonresident establishments that have been granted an exception under subdivision (e) of this section. The intra-company transfer exemption shall not apply to outsourcing facilities.
    2. Application. Nonresident establishments shall apply to the department for registration upon forms prescribed by the department. The application for nonresident manufacturers, outsourcing facilities or wholesalers of prescription drugs and/or devices shall be accompanied by a fee of $825. The application for nonresident pharmacies shall be accompanied by a fee of $345.
    3. Renewal of registration. All registrations for nonresident establishments shall be renewed on dates set by the department. The triennial registration fee for the renewal of a registration of a nonresident manufacturer, outsourcing facility or wholesaler shall be $520 or a prorated share thereof, as determined by the department. The triennial registration fee for the renewal of a registration of a nonresident pharmacy shall be $260 or a prorated share thereof, as determined by the department. Nonresident establishments that fail to demonstrate that they are licensed and/or registered in good standing with their state of residence shall not meet the requirements for renewal of registration. Additionally, non-resident outsourcing facilities that fail to demonstrate that the facility is registered as an outsourcing facility under the Federal Food, Drug and Cosmetic Act shall not meet the requirements for renewal of registration.
    4. Failure to register shall subject the nonresident establishment to the late fees set forth in section 6502(3) of the Education Law.
    5. In order to be registered nonresident establishments shall:
      1. be licensed and/or registered in good standing with the state of residence;
      2. maintain, in readily retrievable form, records of drugs and/or devices shipped into New York State;
      3. supply, upon request, all information needed by the department to carry out the department's responsibilities under law;
      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 New York State, except for controlled substances shipped, mailed, or delivered into New York State, the nonresident pharmacy shall follow Federal law and New York State law;
      5. designate a resident agent in this state for service of process pursuant to Rule 318 of the Civil Practice Law and Rules; and
      6. meet the following requirements of the Education Law to the extent that they pertain to the delivery of prescription drugs and devices into New York State: Education Law, sections 6802, 6810, 6811, 6811-b, 6813, 6814, 6815, 6816, 6816-a, 6817, 6822, 6824, and 6825.
    6. Additional registration requirements for nonresident establishments that are pharmacies.
      1. Toll-free number. Nonresident establishments that are pharmacies shall provide a toll-free telephone number that is available during normal business hours at least 40 hours per week, to enable communication between a patient in New York State and a pharmacist at the pharmacy who has access to the patient's records, and place such toll free number on a label affixed to each drug or device container.
      2. Drug retail price lists. Nonresident establishments that are pharmacies that sell prescription medications at retail shall meet the requirements of subdivisions (1), (2), (3), and (5) of section 6826 of the Education Law for a drug retail price list. Such pharmacies that offer to dispense prescription drugs to consumers in New York State through a website on the Internet shall post on such website a notice of the availability of the drug retail price list. Such registered pharmacies that offer to dispense prescription drugs to consumers in New York State through mail order shall include a printed notice with each delivery of a prescription drug informing the consumer of the availability of the drug retail price list and a toll-free telephone number to obtain the list.
    7. Additional requirements for nonresident establishments that are outsourcing facilities.
      1. 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, on a form prescribed by the Commissioner, which shall include, but not be limited to:
        1. identification of the drugs compounded by such outsourcing facility during the previous six-month period; and
        2. with respect to each such identified drug, provide 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 individuals units produced; and the national drug code number of the final product, if assigned.
      2. Outsourcing facilities shall maintain quality control records for determining beyond use dating and stability for five years and shall make such records available to the department for review and copying upon request.
      3. Outsourcing facilities shall comply with the special provisions relating to outsourcing facilities set forth in Education Law section 6831.
      4. Outsourcing facilities shall comply with current good manufacturing practices as specified in parts 210 and 211 of title 21, Code of Federal Regulations (2014 edition, Superintendent of Documents, U.S. Government Printing Office, Washington DC 20402; 2014, available at New York State Board of Pharmacy, 2nd Floor, 89 Washington Avenue, Albany, New York 12234).
      5. At all times such facilities shall be under the supervision of a pharmacist licensed and registered to practice pharmacy in New York State.
      6. Upon initial registration and at each renewal, such facilities shall submit to the department documentation that the facility is registered as an outsourcing facility under the Federal Food, Drug and Cosmetic Act.
      7. Upon initial registration and at least annually thereafter, such facilities shall submit to the department the results of an inspection by either: representatives of the Federal Food and Drug Administration, this department or a third party acceptable to the department.
      8. No outsourcing facility may distribute or dispense any drug to any person pursuant to a prescription unless it is also a New York registered pharmacy and meets all other applicable requirements of federal and State law.
  3. Disciplinary action.
    1. Nonresident pharmacies shall be subject to disciplinary action in accordance with the requirements of subdivision (6) of section 6808-b of the Education Law, section 6510 of the Education Law and implementing regulations, including but not limited to section 3.3 and Part 17 of this Title.
    2. A nonresident establishment shall be subject to disciplinary action for:
      1. professional misconduct, as defined in section 6509 of the Education Law;
      2. unprofessional conduct, as defined in section 29.1(b) (1)-(3), (5)-(11), (12)(i)(a), (13) and (14) of this Title;
      3. unprofessional conduct, as defined in section 29.2(a)(1)-(2), (4)-(6), (8), (10) and (14) of this Title;
      4. unprofessional conduct, as defined in section 29.7(a)(16), (17) and (19) of this Title; and
      5. failure to meet the registration requirements prescribed in subdivision (b) of this section, any other requirements of this section, and the requirements of section 6808-b of the Education Law.
    3. In a disciplinary action, a nonresident establishment shall be subject to revocation or suspension of its registration and other applicable penalties in accordance with Article 130 of the Education Law.
  4. Notification of change of address or discontinuance. A registered nonresident manufacturer or wholesaler shall notify the department on forms prescribed by the department of a change of address of the establishment or the discontinuance of the establishment within 10 days after such change of address or discontinuance. A registered nonresident outsourcing facility shall notify the department on forms prescribed by the department not less than 30 days prior to the expected date of relocation or discontinuance.
  5. Exception to registration requirements. Upon application by a nonresident pharmacy, manufacturer or wholesaler, the department may grant an exception to the registration requirements of this section to a nonresident establishment that restricts its sale or dispensing of prescription drugs and/or devices to residents of New York State to isolated transactions, as defined in subdivision (a) of this section. The isolated transactions exception shall not apply to nonresident outsourcing facilities.
  6. Reporting requirements for registered nonresident establishments that are outsourcing facilities. Registered nonresident outsourcing facilities shall provide any information and/or submit reports to the department at the Commissioner’s request.

§63.9 Immunizations and emergency treatment of anaphylaxis pursuant to patient specific and non-patient specific orders and protocols.

  1. Applicability. This section shall apply only to the extent that the applicable provisions in Education Law sections 6527, 6801, 6802, 6828 and 6909, authorizing certified pharmacists to administer certain immunization agents and medications for the emergency treatment of anaphylaxis, have not expired or been repealed.
  2. Immunizations.
    1. Pursuant to section 6801 of the Education Law, a pharmacist with a certificate of administration issued by the Department pursuant to paragraph (3) of this subdivision shall be authorized to administer immunization agents prescribed in paragraph (2) of this subdivision to patients therein specified provided that:
      1. the pharmacist meets the requirements for a certificate of administration prescribed in paragraph (3) of this subdivision and the order and protocol meet the requirements set forth in paragraph (5) of this subdivision; and
      2. with respect to non-patient specific orders:
        1. the immunization is prescribed or ordered by a licensed physician or certified nurse practitioner with a practice site in the county in which the immunization is administered; or
        2. if the immunization is administered in a county with a population of 75,000 or less, the immunization shall be prescribed or ordered by a licensed physician or certified nurse practitioner with a practice site in the county in which the immunization is administered or in an adjoining county.
    2. Authorized immunization agents. A certified pharmacist who meets the requirements of this section shall be authorized to administer to patients 18 years of age or older:
      1. immunizing agents to prevent influenza or pneumococcal disease or meningococcal disease pursuant to a patient specific order or a non-patient specific order; and
      2. immunizing agents to prevent acute herpes zoster, pursuant to a patient specific order.
    3. Requirements for a certificate to administer immunizations. No licensed pharmacist shall administer immunizing agents without a certificate of administration issued by the Department. For purposes of this section, a certified pharmacist shall mean a licensed pharmacist who is issued a certificate of administration pursuant to this paragraph. To meet the requirements for a certificate of administration, the licensed pharmacist shall submit an application with the fee specified in section 6828 of the Education Law and present satisfactory evidence of completion of the requirements set forth in one of the following subparagraphs:
      1. Training course. Completion of a training course in the administration of immunizations acceptable to the Commissioner and the Commissioner of Health, within the three years immediately preceding application for a certificate of administration. Such course shall include, but not be limited to, instruction in:
        1. techniques for screening patients and for obtaining informed consents;
        2. techniques in the administration of immunizing agents, including the injection of a harmless, non-medicinal saline solution into voluntary recipients;
        3. indications, precautions and contraindications in the use of immunizing agents;
        4. handling of emergencies, including the use of medications required for emergency treatment of anaphylaxis;
        5. cardio-pulmonary resuscitation techniques; and
        6. recordkeeping and reporting of immunizations and information; or
      2. Training course associated with Doctor of Pharmacy Degree.
        1. Graduation with a Doctor of Pharmacy degree from a professional program of study in pharmacy that is registered by the Department pursuant to Part 52 of this Chapter, or is accredited by an acceptable accrediting agency as defined in section 63.1(a) of this Part, or is determined by the Department to be the equivalent of such a registered or accredited program; and
        2. completion of training in the administration of immunization agents satisfactory to the Department, including instruction in the areas identified in subparagraph (i) of this paragraph, received as part of his/her pharmacy degree program, provided that such training was completed within the three years immediately preceding application for a certificate of administration; or
      3. Certificate of administration issued by another jurisdiction.
        1. Possession of a current certificate of administration issued by another jurisdiction, authorizing the pharmacist to administer immunization agents based on the pharmacists completion of training or coursework in the administration of immunizing agents as described in subparagraph (i) of this paragraph, or its equivalent as determined by the Department; and
        2. continuous practice in the administration of immunizing agents since the pharmacist received such training or completion of a retraining program in the administration of immunization agents, acceptable to the Commissioner and the Commissioner of Health, provided that such retraining incorporates the areas identified in subparagraph (i) of this paragraph.
    4. Standards, procedures and reporting requirements for the administration of immunization agents. Each certified pharmacist shall comply with the following requirements when administering an immunization agent pursuant to either a patient specific order or a non-patient specific order and protocol:
      1. prior to administering an immunization agent, a certified pharmacist shall ensure that each potential recipient is assessed for contraindications that would preclude immunization(s);
      2. a certified pharmacist shall be responsible for having emergency anaphylaxis treatment agents, related syringes and needles available at the location at which immunizations will be administered;
      3. a certified pharmacist shall inform each recipient of potential side effects and adverse reactions, orally and in writing, prior to immunization;
      4. a certified pharmacist shall not administer immunizations unless the recipient is adequately informed as prescribed in this paragraph and the recipient consents to the immunization; except for recipients incapable of consenting to the administration of an immunization, in which case, before an immunization may be administered, either a person legally responsible for the recipient shall have given prior written consent to the immunization after having been informed in writing of potential side effects and adverse reactions, or a person legally responsible for the recipient is in attendance during the immunization and consents to the immunization after having been informed of potential side effects and adverse reactions;
      5. a certified pharmacist shall provide written instructions to the recipient regarding the appropriate course of action in the event of contraindications or adverse reactions, which statements are required to be developed by a competent entity knowledgeable about the adverse reactions of the immunization agent which shall be administered, such as the Centers for Disease Control of the U.S. Department of Health and Human Services, which issues vaccine information statements;
      6. a certified pharmacist shall provide a copy of the appropriate vaccine information statement to the recipient, or other person legally responsible when the patient is incapable of consenting to immunization administering, before administering the immunization;
      7. a certified pharmacist shall provide to each recipient or other person legally responsible when the recipient is incapable of consenting to immunization, a signed certificate of immunization with the recipient's name, date of immunization, address of administration, administering pharmacist, immunization agent, manufacturer and lot number. With the consent of the recipient or a person legally responsible when the recipient is incapable of consenting, the certified pharmacist shall communicate this information to the recipient's primary health care practitioner, if one exists, within one month of the administration of such immunization, and such communication may be transmitted in electronic format;
      8. a certified pharmacist shall report any adverse outcomes as may be required by Federal law on the vaccine adverse event reporting system form of the Centers for Disease Control of the U.S. Department of Health and Human Services, or on the successor form;
      9. a certified pharmacist shall ensure that a record of all persons immunized including the recipient's name, date, address of administration, administering pharmacist, immunization agent, manufacturer and lot number is recorded and maintained in accordance with section 29.2(a)(3) of this Title;
      10. to the extent required by the Public Health Law, the Education Law and/or the New York City Health Code, a certified pharmacist shall report the administration of any immunizations to the New York State Department of Health and/or to the New York City Department of Health and Mental Hygiene, in a manner required by the Commissioner of Health of the State of New York or of the City of New York, as applicable. Such report shall not include any individually identifiable health information unless: (a) such information is otherwise required by law, or (b) the recipient has consented to the disclosure of such information, in which case the information may be included to the extent permitted by law; and
      11. each certified pharmacist shall provide information to recipients on the importance of having a primary health care practitioner, in a form or format developed by the Commissioner of Health.
    5. Order and protocol.
      1. The certified pharmacist shall maintain or ensure the maintenance of a copy of the patient specific order or the non-patient specific order and protocol prescribed by a licensed physician or a certified nurse practitioner which authorizes the certified pharmacist to administer immunization agents in accordance with the requirements of this section. Each patient specific and non-patient specific order shall contain the information prescribed in subparagraph (ii) of this paragraph and for non-patient specific orders, the order shall also incorporate a protocol that meets the requirements of subparagraph (iii) of this paragraph. Such order and any protocol accompanying such order shall be considered a record of the patient. A certified pharmacist shall maintain a record of each patient in either:
        1. a patient medication profile that is prepared and retained in conformity with section 63.6(b)(7) of this Part, if one is required; or
        2. in instances where a patient medication profile is not required, on a separate form that is retained by the pharmacist who has administered the immunization, in a retrievable format available to the Department and the patient. Such record shall be maintained in accordance with section 29.2(a)(3) of this Title.
      2. All patient specific orders and non-patient specific orders authorizing a certified pharmacist to administer immunizations to certain patients, shall contain, but need not be limited to, the following information:
        1. the specific immunization agents that the pharmacist is permitted to administer including the indications, dose and route of administration for the vaccine; and
        2. the name, license number, and signature of the licensed physician or nurse practitioner who has issued the order.
      3. Non-patient specific orders shall incorporate a protocol that meets the requirements of subparagraph (iv) of this paragraph and shall also contain:
        1. authorization for one or more named pharmacists, or pharmacists who are not individually named but are identified as employed or under contract with an entity that it legally authorized to employ or contract with pharmacists to provide pharmaceutical services, to administer specified immunization agents to a defined group of individuals, for a prescribed period of time;
        2. the name(s) and license number(s) of the of the certified pharmacist(s) authorized to administer the immunization agent(s) pursuant to the order or, for non-patient specific orders that do not identify the pharmacist(s) by name, the name of the entity that is legally authorized to employ or contract with licensed pharmacists to provide pharmaceutical services with whom licensed pharmacists who are not individually named are employed or under contract to administer the prescribed immunization agent(s) pursuant to the order;
        3. in instances where the certified pharmacists are not individually named in the order, but are identified as employed or under contract with an entity that is legally authorized to employ or contract with certified pharmacists to provide pharmaceutical services, a statement limiting the certified pharmacists to administering immunizations only in the course of such employment or pursuant to such contract; and
        4. the period of time that the order is effective, including the beginning and ending dates.
      4. The protocol, incorporated into the non-patient specific order shall include, but need not be limited to, the standards, procedures and reporting requirements set forth in paragraph (4) of this subdivision.
  3. Anaphylaxis treatment agents.
    1. Pursuant to sections 6801 and 6802 of the Education Law, each pharmacist who is issued a certificate of administration pursuant to this section shall be authorized to administer medications for the emergency treatment of anaphylaxis to patients 18 years of age or older.
    2. Standards, procedures and reporting requirements for the administration of anaphylaxis treatment agents. Each certified pharmacist shall comply with the following requirements when administering medications for the emergency treatment of anaphylaxis under this section:
      1. each certified pharmacist shall ensure that a record of all persons to whom such pharmacist has administered an anaphylaxis treatment agent, including but not limited to: the recipient's name, date, address of administration, administering pharmacist, anaphylaxis treatment agent, manufacturer, and lot number, is recorded and maintained in either a patient medication profile, if one is required, that is prepared and retained in conformity with section 63.6(b)(7) of this Part; or, in the event that a patient medication profile is not required, on a separate form retained by the pharmacist who administered the anaphylaxis treatment agent and shall be maintained in accordance with section 29.2(a)(3) of this Title;
      2. each certified pharmacist shall contact the local emergency medical services system following the administration of the anaphylaxis treatment agent, or shall ensure that equivalent follow-up care is provided through other arrangements; and
      3. certified pharmacists shall report to the local emergency medical system or other provider of equivalent follow-up care information concerning the administration of the anaphylaxis treatment agent, including but not limited to: the name of the agent, when it was administered, the dosage, strength, and route of administration. Certified pharmacists shall also report such information to the patient's primary health care practitioner if one exists, unless the patient is unable to communicate the identity of his or her primary health care practitioner.
    3. Non-patient specific order and protocol.
      1. The certified pharmacist shall either maintain or ensure the maintenance of a copy of the non-patient specific order and protocol prescribed by a licensed physician or a certified nurse practitioner that authorizes such pharmacist to administer medications for the emergency treatment of anaphylaxis to adults, in accordance with the requirements of paragraph (1) of this subdivision. The order prescribed in subparagraph (ii) of this paragraph shall incorporate a protocol that meets the requirements of subparagraph (iii) of this paragraph. Such order and protocol shall be considered a record of the patient who receives the anaphylaxis treatment agent and maintained as a record for the patient who receives the anaphylaxis treatment agent. A record of each patient shall be maintained in either:
        1. a patient medication profile that is prepared and retained in conformity with section 63.6(b)(7) of this Part, if one exists; or
        2. in instances where a patient medication profile does not exist, on a separate form that is retained by the pharmacist who has administered the immunization, in a retrievable format available to the Department and the patient. Such record shall be maintained in accordance with section 29.2(a)(3) of this Title.
      2. The non-patient specific order shall authorize one or more named certified pharmacists, or certified pharmacists who are not individually named but are identified as employed or under contract with an entity that is legally authorized to employ or contract with pharmacists to provide pharmaceutical services, to administer specified anaphylaxis treatment agents in specified circumstances for a prescribed period of time. In instances in which the certified pharmacists are not individually named in the order, but are identified as employed or under contract with an entity that is legally authorized to employ or contract with certified pharmacists to provide pharmaceutical services, such pharmacists shall not be authorized by such order to administer anaphylaxis treatment agents outside of such employment or contract. The order shall contain but shall not be limited to the following information:
        1. the specific anaphylaxis treatment agents that the certified pharmacists are permitted to administer;
        2. the period of time that the order is effective, including the beginning and end dates;
        3. the name and license number of the certified pharmacist(s) authorized to administer the anaphylaxis treatment agent(s) pursuant to the order; or the name of the entity that is legally authorized to employ or contract with certified pharmacists to provide pharmaceutical services with whom certified pharmacists who are not individually named are employed or under contract to administer the prescribed anaphylaxis treatment agent(s) pursuant to the order;
        4. in instances in which the certified pharmacists are not individually named in the order, but are identified as employed or under contract with an entity that is legally authorized to employ or contract with certified pharmacists to provide pharmaceutical services, the order shall contain a statement limiting the certified pharmacists to administering anaphylaxis treatment agents only in the course of such employment or pursuant to such contract; and
        5. the name, license number, and signature of the licensed physician or certified nurse practitioner who has issued the order.
      3. The protocol, incorporated into the order prescribed in subparagraph (ii) of this paragraph, shall include, but need not be limited to, the requirements set forth in paragraph (2) of this subdivision.

§63.10 Collaborative drug therapy management

  1. Applicability. This section shall apply only to the extent that the applicable provisions in Education Law sections 6801 and 6801-a, authorizing certain pharmacists to participate in collaborative drug therapy management, have not expired or been repealed.
  2. Experience requirement for participating pharmacists.
    1. As used in Education Law section 6801-a(2)(b), a year of experience shall mean not less than 1,680 hours of work as a pharmacist within a period of one calendar year.
    2. In order to be counted as a year of experience that includes clinical experience in a health facility, such experience shall include, on average, not less than 15 hours per week of clinical experience which involves consultation with physicians with respect to drug therapy, as determined by the facility that employs or is affiliated with the pharmacist.

§63.11 Interpretation and translation requirements for prescription drugs

  1. Definitions. As used in this section:
    1. Covered pharmacy shall mean 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.
    2. Corporate entity shall include related subsidiaries, affiliates, successors, or assignees doing business as or operating under a common name or trading symbol of the covered pharmacy.
    3. Limited English proficient individual or LEP individual shall mean 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.
    4. 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.
    5. Competent oral interpretation shall mean an 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.
    6. Pharmacy primary languages shall mean those languages, up to a maximum of seven languages other than English, spoken by one percent or more of the population of the State, as determined by the U.S. Census. If more than seven languages other than English are spoken by one percent or more of the population, the pharmacy primary languages shall be limited to seven most spoken languages, as determined by the U.S. Census.
    7. Mail order pharmacy shall mean a pharmacy that dispenses most of its prescriptions through the United States postal service or other delivery system.
  2. Provision of competent oral interpretation services and translation services. Except as otherwise provided in subdivision (e) of this section:
    1. For purposes of counseling an individual about his or her prescription medications or when soliciting information necessary to maintain a patient medication profile, each covered pharmacy and mail order pharmacy shall provide free, competent oral interpretation services and translation services in such individual’s preferred pharmacy primary language to each LEP individual requesting such services or when filling a prescription that indicates that the individual is limited English proficient at such covered pharmacy or mail order pharmacy, unless the LEP individual is offered and refuses such services.
    2. With respect to prescription medication labels, warning labels and other written materials, each covered pharmacy and mail order pharmacy shall provide free, competent oral interpretation services and translation services to each LEP individual filling a prescription at such covered pharmacy or mail order pharmacy in such individual’s preferred pharmacy primary language, unless the LEP individual is offered and refuses such services or the medication labels, warning labels and other written materials have already been translated into the language spoken by the LEP individual.
    3. Translation and competent oral interpretation shall be provided in the preferred pharmacy primary language of each LEP individual, provided that no covered pharmacy or mail order pharmacy shall be required to provide translation or competent oral interpretation of more than seven languages.
    4. The services required by this subdivision may be provided by a staff member of the covered pharmacy or mail order pharmacy or a third-party contractor. Such services shall be provided on an immediate basis but need not be provided in-person or face-to-face.
  3. Notification relating to language assistance services. Except as otherwise provided in subdivision (e) of this section:
    1. In accordance with Education Law section 6829(3), each covered pharmacy shall conspicuously post a notice to inform LEP individuals of their rights to free, competent oral interpretation services and translation services. Such notice shall include the following statement in English and in each of the pharmacy primary languages: "Point to your language. Language assistance will be provided at no cost to you." With each initial transaction with patients seeking mail order services, mail order pharmacies shall provide printed materials in English and in each of the pharmacy primary languages, explaining the availability of competent oral interpretation services and translation services. In addition, mail order pharmacies that are nonresident establishments shall provide any required information pursuant to section 63.8(b)(6) of this Part in English and in each of the pharmacy primary languages.
    2. The statement in each of the pharmacy primary languages shall be in 20 point bold face, Arial type in a color that sharply contrasts with the background color of the sign. Each such statement shall be enclosed in a box, and there shall be at least a 1/4 inch clear space between adjacent boxes.
    3. The statements in each of the pharmacy primary languages shall be printed on one sign that shall be conspicuously displayed at or adjacent to each counter where prescription drug orders are dropped off and where prescriptions are picked up, and near every cash register at which payment is received for prescription drugs. Such signs shall be positioned so that a consumer can easily point to the statement identifying the language in which such person is requesting assistance.
  4. Waivers. An application for a waiver of the provisions of subdivisions (b) and (c) of this section shall be made on a form prescribed by the department. The burden of substantiating the validity of a request for a waiver shall be on the applicant.
    1. Each application shall be specific to a covered pharmacy, or mail order pharmacy regardless of common ownership.
    2. The applicant shall clearly document the financial or physical constraints, threat to other services provided, or other circumstances upon which the request is based.
    3. No waiver shall be granted in the absence of a showing that implementation of the provisions of subdivisions (b) and (c) of this section would be unnecessarily burdensome when compared to the need for the translation and competent oral interpretation services.
    4. The applicant shall identify alternative sources of competent oral interpretation services or translation services available for LEP individuals within a reasonable distance.
    5. In the event a request for waiver is approved, the duration of a waiver shall be one year and may be renewed upon approval of a new waiver application by the department.
  5. In accordance with section 5 of Part V of Chapter 57 of the Laws of 2012, the provisions of subdivisions (a) through (d) of this section shall preempt any contrary local law or ordinance; provided, however, that cities with a population of 100,000 or more may retain or promulgate such local laws or ordinances imposing additional or stricter requirements relating to interpretation services or translation services in pharmacies. Nothing in this section shall diminish or impair any requirement that any pharmacy or pharmacist provide any language assistance, interpretation, or translation under any applicable federal or state law, local law or ordinance (unless preempted by this section), consent decree, or judicial settlement, judgment or order.

§63.12 Standardized patient-centered data elements to be used on all drug labels

In accordance with section 6830 of the Education Law, all prescription medicine dispensed to patients in this State must include standardized patient-centered data elements as prescribed by in this section

  1. Definitions. As used in this section:
    1. Critical elements shall consist of:
      1. patient name;
      2. directions for use by the patient, which directions shall be structured in full sentences; and
      3. drug name and strength.
    2. Important elements shall consist of:
      1. name, address and telephone number of the pharmacy;
      2. patient’s address;
      3. name of prescriber;
      4. the date of filling or refilling of the prescription; and
      5. the prescription number or other identifying number assigned to the prescription.
  2. All prescription drug labels shall contain all of the critical elements and all of the important elements.
    1. Critical elements of each prescription label shall be:
      1. emphasized by being highlighted in color, in bold type, or both: and
      2. printed in a minimum of a 12-point font.
    2. Important elements of each prescription label and any other information contained on the label shall not be highlighted in color or in bold type, shall be legible and shall not be presented in a fashion that undermines the emphasis on the critical elements.
Last Updated: July 3, 2014