New York Codes, Rules and Regulations › Title 8 - EDUCATION DEPARTMENT › Chapter II - Regulations of the Commissioner › Subchapter B - Regulation of Professions › Part 63 - Pharmacy and registered pharmacy technicians › Section 63.6 - Registration and operation of New York establishments

Current through Register Vol. 46, No. 28, July 10, 2024
(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.