N.Y. Comp. Codes R. & Regs. tit. 8 § 63.8

Current through Register Vol. 46, No. 25, June 18, 2024

Section 63.8 - Registration of nonresident establishments

(a)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.

(b)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, nonresident 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 fee set forth in section 6502(3) of the Education Law.

(5) In order to be registered, nonresident establishments shall:

(i) be licensed and/or registered in good standing with the state of residence;

(ii) maintain, in readily retrievable form, records of drugs and/or devices shipped into New York State;

(iii) supply, upon request, all information needed by the department to carry out the department's responsibilities under law;

(iv) 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;

(v) designate a resident agent in New York State for service of process pursuant to Rule 318 of the Civil Practice Law and Rules; and

(vi) 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.

(i) 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 shall place such toll-free number on a label affixed to each drug or device container.

(ii) 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 and a toll-free telephone number to obtain the 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. Additional requirements for nonresident establishments that are 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 (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, 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 registered pharmacy and meets all other applicable requirements of Federal and State law.

(c)Disciplinary action.

(1) Nonresident establishments 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:

(i) professional misconduct, as defined in section 6509 of the Education Law;

(ii) unprofessional conduct, as defined in section 29.1(b)(1)-(3), (5)-(11), (12)(i) (a), (13) and (14) of this Title;

(iii) unprofessional conduct, as defined in section 29.2(a)(1)-(2), (4)-(6), (8), (10) and (14) of this Title;

(iv) unprofessional conduct, as defined in section 29.7(a)(16), (17) and (19) of this Title; and

(v) 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.

(d) Notification of change of address or discontinuance.

A registered nonresident manufacturer or wholesaler shall notify the department on forms prescribed by the department 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.

(e) Exception to registration requirements.

Upon application by a nonresident pharmacy, manufacturer or wholesaler, establishment, 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.

(f) 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.

N.Y. Comp. Codes R. & Regs. Tit. 8 § 63.8

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