N.Y. Comp. Codes R. & Regs. tit. 8 § 63.6

Current through Register Vol. 46, No. 51, December 18, 2024

Section 63.6 - Registration and operation of New York establishments

(a)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. 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.

(i) For the purposes of this section:

(a) 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;

(b) the term electronic means of or relating to technology having electrical, digital, magnetic, wireless, optical, electromagnetic, or similar capabilities; and

(c) 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.

(ii) 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:

(a) the prescription shall contain the electronic signature of the prescriber;

(b) 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;

(c) 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;

(d) 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;

(e) except when the prescriber inserts an electronic direction to dispense the drug as written, the prescriber's electronic signature shall designate approval of an interchangeable biological product by a pharmacist. Notwithstanding any other provision of this section or any other law to the contrary, when an interchangeable biological product is not available and the biological product originally prescribed is available and the pharmacist agrees to dispense the prescribed biological product for a price that will not exceed the price that would have been charged for the interchangeable biological substitute had it been available, substitution of an interchangeable biological product will not be required. If the interchangeable biological product is not available and a medical emergency situation, which for purposes of this section is defined as any condition requiring alleviation of severe pain or which threatens to cause disability or take life if not promptly treated, exists, then the pharmacist may dispense the prescribed biological product at his or her regular price. In such instances, the pharmacist must record the date, hour and nature of the medical emergency on the back of the prescription and keep a copy of all such prescriptions;

(f) 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

(g) 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.

(iii) 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.

(i) 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:

(a) the fact that an authorized refill of the prescription has been transferred;

(b) the name, address and telephone number of the pharmacy to which it was transferred;

(c) the name of the pharmacist receiving the prescription information;

(d) the name of the pharmacist transferring the information; and

(e) the date of the transfer.

(ii) 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:

(a) obtain all information required by section 29.7(a)(1) of this Title;

(b) produce a hard copy of such information and ensure that the term "refill transfer" appears on the face of the hard copy; and

(c) 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.

(iii) 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.

(iv) The hard copy of the transferred prescription shall be maintained for a period of five years from the date of filling.

(iv) 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.

(b)Pharmacies.

(1) To secure and retain registration, a pharmacy shall be equipped with at least the following utensils:

(i) weighing device sensitive to 6 mg;

(ii) metric weights, if needed for the operation of the device in subparagraph (i) of this paragraph;

(iii) devices capable of measuring volumes from 0.1 ml to 500 ml; and

(iv) 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 of pharmacy.

(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.

(i) There shall be present at all hours when the pharmacy is open at least one pharmacist who:

(a) 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

(b) 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.

(ii) In addition to the items and articles of equipment required by this subdivision, the pharmacy shall be equipped with at least the following:

(a) laminar flow hood;

(b) dose calibrator;

(c) exhaust hood and filter system;

(d) chromatography apparatus;

(e) apparatus or materials for the determination of pH;

(f) single-channel and/or multichannel scintillation detection system; and

(g) microscope.

(iii) 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.

(i) 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 the 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.

(a) 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.

(b) 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.

(c) 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.

(d) 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 section 29.7(a)(21) 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.

(e) 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.

(ii) 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.

(a) 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 (i)(a)(1) through (8) 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.

(b) 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.l(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 (i)(a)(1) through (8) of this paragraph. Such counseling shall be conducted via telephone or in an in-person face-to-face meeting.

(c) 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 or interchangeable biological product 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 (i)(a)(1) through (8) 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.

(d) If upon presentation of the prescription, the pharmacist or 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 (i)(a)(1) through (8) 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 and a toll-free telephone number to obtain the 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.

(c)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 and no outstanding 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:

(i) a chemist who holds a bachelor's degree in chemistry; or

(ii) 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:

(i) a respiratory therapist certified by a national accrediting body;

(ii) a person holding a bachelor's degree in chemistry, microbiology, chemical engineering or a related field; or

(iii) 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) Supervisor requirements for wholesalers transfilling medical oxygen. Wholesalers that transfill medical oxygen shall ensure any person responsible for supervising the transfilling of medical oxygen is either:

(i) a respiratory therapist certified by a national accrediting body;

(ii) a person holding a bachelor's degree in chemistry, microbiology, chemical engineering or a related field;

(iii) a person having two years of education beyond high school and two years of experience in the handling of compressed medical gases satisfactory to the state board of pharmacy; or

(iv) a person having training in accordance with the requirements established in section 211.25 of title 21 of the code of federal regulations.

(4) The supervisor of an establishment designated pursuant to paragraphs (1), (2), and (3) of this subdivision shall not be at the same time the supervisor of any other establishment registered by the board.

(5) 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 no 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, Office of the Professions, 89 Washington Ave., 2nd Floor, Albany, NY 12234).

(6) 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.

(7) 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 or a designee of the Commissioner of Education, 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.

(8) Additional requirements for outsourcing facilities.

(i) 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:

(a) identification of the drugs compounded by such outsourcing facility during the previous six-month period; and

(b) 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.

(ii) 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.

(iii) Outsourcing facilities shall comply with the special provisions relating to outsourcing facilities set forth in Education Law section 6831.

(iv) 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, NY 12234).

(v) At all times such facilities shall be under the supervision of a pharmacist licensed and registered to practice pharmacy in New York State.

(vi) 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.

(vii) 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.

(viii) 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.

(ix) 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.

(d) 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.

N.Y. Comp. Codes R. & Regs. Tit. 8 § 63.6

Amended, New York State Register October 1, 2014/Volume XXXVI, Issue 39, eff. 10/1/2014

Amended New York State Register April 25, 2018/Volume XL, Issue 17, eff. 4/25/2018

Amended New York State Register September 25, 2019/Volume XL, Issue 39, eff. 9/25/2019

Amended New York State Register July 31, 2024/Volume XLVI, Issue 31, eff. 7/15/2024, exp. 9/12/2024 (Emergency)

Amended New York State Register September 25, 2024/Volume XLVI, Issue 39, eff. 9/25/2024

Amended New York State Register October 2, 2024/Volume XLVI, Issue 40, eff. 9/13/2024, exp. 11/11/2024 (Emergency)