§ 20-627 — Nonresident pharmacy. Definitions. Certificate of registration. Requirements.

Connecticut § 20-627

• Jurisdiction: Connecticut
• Title 20: Professional and Occupational Licensing, Certification, Title Protection and Registration. Examining Boards
• Ch. 400j: Pharmacy

Text

(a) As used in sections 20-627 to 20-630, inclusive, “nonresident pharmacy” means any pharmacy located outside this state that ships, mails or delivers, in any manner, legend devices or legend drugs into this state pursuant to a prescription order. (b) A nonresident pharmacy shall be registered with the department, upon approval of the commission, and shall: (1) Disclose annually in a report to the commission the location, names and titles of all principal corporate officers, if applicable, and all pharmacists who are dispensing drugs or devices to residents of this state; (2) A nonresident pharmacy shall file a report within ten days after any change of name, ownership, management, officers or directors. Such report shall be accompanied by the filing fee set forth in section 20-601 . Any nonresident pharmacy that fails to give notice as required pursuant to this subdivision within ten days after the change shall pay the late fee set forth in section 20-601 ; (3) Comply with all lawful directions and requests for information from the regulatory or licensing agency of the state in which it is licensed as well as comply with all requests for information made by the commission or department pursuant to this section; (4) Disclose to the department whether the nonresident pharmacy is dispensing sterile pharmaceuticals, as defined in section 20-633b , within this state. If any such dispensed sterile pharmaceutical is not patient-specific, the nonresident pharmacy shall submit a copy of the manufacturing license or registration issued by the regulatory or licensing agency of the state in which it is licensed, and a copy of any registration issued by the federal Food and Drug Administration to the department; (5) Maintain at all times, a valid unexpired license, permit or registration to conduct such pharmacy in compliance with the laws of the state in which the nonresident pharmacy is located; (6) Before receiving a certificate of registration from the department, submit a copy of the most recent inspection report resulting from an inspection conducted by the regulatory or licensing agency of the state in which the nonresident pharmacy is located. If the nonresident pharmacy is delivering sterile compounded products within this state, such inspection report shall include a section based on standards required in the most recent United States Pharmacopeia, Chapter 797, as amended from time to time. If the state in which the nonresident pharmacy is located does not conduct inspections based on standards required in the most recent United States Pharmacopeia, Chapter 797, as amended from time to time, such nonresident pharmacy shall provide proof to the department that it is in compliance with such standards; (7) A nonresident pharmacy shall provide a toll-free telephone number to facilitate communication between patients in this state and a pharmacist at such nonresident pharmacy who has access to the patient's records at all times. Such toll-free telephone number shall be disclosed on a label affixed to each container of drugs dispensed to patients in this state; (8) Notify the department if the nonresident pharmacy has had any disciplinary action or written advisement or warning by any federal or state regulatory agency or any accreditation body not later than ten business days after being notified of such action, advisement or warning; and (9) Provide to the department the names and addresses of all residents of this state to whom legend devices or legend drugs have been delivered, not later than twenty-four hours after the nonresident pharmacy initiates a recall of any legend devices or legend drugs.

Legislative History

(P.A. 96-127, S. 1; P.A. 99-175, S. 45; P.A. 14-224, S. 3; P.A. 18-141, S. 11.) History: P.A. 99-175 made technical changes, reordered Subsecs., amended Subsec. (a) to delete reference to Sec. 20-184a and deleted former Subsec. (c); P.A. 14-224 amended Subsec. (b) by adding new Subdiv. (3) re disclosure by nonresident pharmacy, redesignating existing Subdivs. (3) and (4) as Subdivs. (4) and (5), and adding provision re inspection report for nonresident pharmacy delivering sterile compounded products within this state in redesignated Subdiv. (5), redesignated existing Subsec. (c) as Subsec. (b)(6) and amended same to require toll-free telephone number for patients at all times, added Subsec. (b)(7) re notification of disciplinary action or warning, added Subsec. (b)(8) re provision of names and addresses of residents to whom legend devices or legend drugs have been delivered, and made technical changes, effective July 1, 2014; P.A. 18-141 amended Subsec. (b) by designating provision re nonresident pharmacy to file report as Subdiv. (2) and amending same by deleting reference to additional report, replacing “thirty days” with “ten days”, replacing “office, corporate officer or pharmacist” with “name, ownership, management, officers or directors”, adding provisions re filing fee and late fee, redesignating Subdivs. (2) to (8) as Subdivs. (3) to (9), and making technical changes, effective June 11, 2018.