D.C. Mun. Regs. tit. 22, r. 22-B1903

Current through Register Vol. 71, No. 49, December 6, 2024

Rule 22-B1903 - REGISTRATION OF NONRESIDENT PHARMACIES

1903.1

The purpose of these rules is to provide standards for the operation of nonresident pharmacies, which dispense or distribute prescription drugs or medical devices, directly or indirectly such as through the use of an agent or intermediary, to persons located within the District of Columbia. The Department has determined that these rules are necessary to protect the health and welfare of the citizens of the District of Columbia.

1903.2

Nonresident pharmacies which dispense, distribute, ship, mail, or deliver in any manner, prescription drugs or medical devices into the District of Columbia, directly or indirectly, shall, in addition to complying with all applicable federal laws, be registered by the Department and comply with the pharmacy and drug laws and regulations of the District of Columbia, unless and unto the extent that compliance would violate the pharmacy or drug laws or regulations in the state in which the nonresident pharmacy is located.

1903.3

No person or entity required to be registered shall ship, mail, or deliver in any manner, prescription drugs or medical devices into the District of Columbia, directly or indirectly, until a Certificate of Registration is issued by the Department.

1903.4

A nonresident pharmacy shall:

(a) Register with the Department on a form provided by the Department and pay the required fee (no registration fee shall be required for the registration of a nonresident pharmacy operated by the United States government or any other state government); and

(b) Biennially renew the registration and pay the required fee.

1903.5

The term of a registration issued or renewed pursuant to this chapter is two (2) years, or the balance of the registration period, whichever is shorter, and shall expire on May 31 of each odd numbered year regardless of the issuance date unless the Director changes the renewal system pursuant to § 1903.6.

1903.6

The Director may change the renewal system to another system for the administrative convenience of the Director.

1903.7

If the Director changes the renewal system pursuant to § 1903.6 of this chapter, the term of a registration that is in effect on the date of the Director's determination may be extended up to two (2) years in order to permit an orderly transition.

1903.8

As part of the application for registration or renewal of registration, a nonresident pharmacy shall:

(a) Submit evidence to the Department that the nonresident pharmacy holds a pharmacy license, registration, or permit, in good standing, issued by the state in which the pharmacy is located;

(b) Submit evidence to the Department that the nonresident pharmacy holds a valid DEA registration number, if the pharmacy dispenses prescription-controlled substances listed in any Schedule into the District of Columbia;

(c) Submit evidence that the pharmacist in charge holds a valid license in good standing in the state in which the nonresident pharmacy is located;

(d) Provide the name, address, and title of its:

(1) Owner or proprietor;

(2) Pharmacist-in-charge, along with his or her license number and state of licensure;

(3) Principal corporate officers;

(4) Pharmacists who are dispensing prescription drugs or medical devices to citizens of the District of Columbia, along with their license numbers and state of licensure; and

(5) Resident agent located within the District of Columbia designated to accept service of process;

(e) Submit a copy of the most recent inspection report resulting from an inspection conducted by the regulatory or licensing agent of the state in which the nonresident pharmacy is located, or the federal agency that inspected;

(f) Indicate whether the nonresident pharmacy is currently engaged in the compounding of sterile pharmaceuticals or intends to engage in the compounding of sterile pharmaceuticals after approval of a registration;

(g) Submit an affidavit by the pharmacist-in-charge certifying that the pharmacist-in-charge has read and understands the pharmacy and drug laws and regulations of the District of Columbia, and that the pharmacistin-charge has made the pharmacy and drug laws and regulations of the District of Columbia available to all pharmacists working in the nonresident pharmacy;

(h) Provide evidence of the nonresident pharmacy's ability to provide to the Department a record of a prescription order dispensed to a resident of the District of Columbia not later than three (3) business days after the time the Department requests the record;

(i) Provide all website address(es) and domain registration(s) to the Department, if applicable; and

(j) If the nonresident pharmacy is solely internet-based or operates primarily as an internet-based pharmacy, the pharmacy shall also:

(1) Submit proof acceptable to the Department of certification by the Verified Internet Pharmacy Practice Sites Program (VIPPS) of the National Association of Boards of Pharmacy, or other national certification program for internet pharmacies acceptable to the Department, for each website and domain registration; and

(2) Submit proof of registration in good standing in the District of Columbia as a foreign corporation.

1903.9

The Director shall deny an application for registration if the applicant fails to provide the required information or documentation.

1903.10

A nonresident pharmacy shall report a change in the name or address of the resident agent in writing to the Department within thirty (30) days after the change.

1903.11

A nonresident pharmacy shall report a change in the pharmacist-in-charge, or corporate officers within thirty (30) days after the change.

1903.12

A nonresident pharmacy which changes proprietorship or ownership, its name, or location shall notify the Department within ten (10) days after the change and apply for a new registration.

1903.13

A nonresident pharmacy shall notify the Department within ten (10) days after closing.

1903.14

A nonresident pharmacy shall, during its regular hours of operation, but not less than six (6) days per week, and a minimum of forty (40) hours per week, provide toll-free telephone communication consultation between patients in the District of Columbia and a licensed pharmacist at the pharmacy who has access to the patient's prescription records. This toll-free number shall be disclosed on a label affixed to each container of drugs or medical device dispensed to patients in the District of Columbia.

1903.15

A nonresident pharmacy shall immediately communicate to a patient or prescribing practitioner any expected delay in delivering the prescribed drug or device which might jeopardize or alter the drug therapy of the patient.

1903.16

A nonresident pharmacy shall maintain, at all times:

(a) A license, registration, or permit in good standing issued in the state in which it is located;

(b) Its records of prescription drugs and devices dispensed to patients in the District of Columbia so that the records are readily retrievable, in hardcopy or electronically, for a period of five (5) years from the date of first dispensing. Records which are more than two (2) years old may be stored offsite as long as they can be retrieved within three (3) business days of a request;

(c) Compliance with the laws and regulations regarding confidentiality of prescription records in the state in which it is located, and if there are no such laws in that state, then the pharmacy shall comply with the confidentiality laws and regulations of the District of Columbia;

(d) Compliance with all requests for information made by the Department pursuant to this section; and

(e) If the pharmacy is internet-based or primarily internet-based:

(1) Certification by the Verified Internet Pharmacy Practice Sites Program (VIPPS) of the National Association of Boards of Pharmacy, or other national certification program for internet pharmacies acceptable to the Department, for each website and domain registration; and

(2) Registration in good standing in the District of Columbia as a foreign corporation.

1903.17

By applying for and being granted registration as a nonresident pharmacy in the District of Columbia, a nonresident pharmacy shall be deemed to have given its consent to provide to the Department, not later than three (3) business days after the time the Department requests the record:

(a) All Information and records concerning a prescription drug or medical device order dispensed to a resident of the District of Columbia;

(b) Any inspection reports, warning notices, notice of deficiency reports, disciplinary actions or any other related reports from the state in which it is located concerning the operation of the nonresident pharmacy for review of compliance with state and federal drug laws; and

(c) All information requested by the Department.

1903.18

If a nonresident pharmacy fails to comply with any provision of § 1903.17 the Department may summarily suspend the registration. The Department may lift a summary suspension imposed under this section if the Department determines that the nonresident pharmacy has provided the requested information or records.

1903.19

In addition to any other appropriate remedies or actions, the Director shall withdraw the registration of a registrant that:

(a) Loses licensure in good standing in the state in which it is located;

(b) Loses registration in good standing in the District of Columbia as a foreign corporation; or

(c) Is conducted in a manner that endangers the public health, welfare and safety.

1903.20

When withdrawing a registration pursuant to § 1903.19 of this chapter, the Director shall give written notice to the registrant citing the basis for withdrawal. The effective date of withdrawal shall be thirty (30) calendar days from the date of service of the notice, or immediately, in the case of danger to the public health, safety, or welfare.

1903.21

The notice required in § 1903.20 of this chapter shall state that the registration shall be automatically withdrawn unless, prior to the effective date, the registrant submits proof satisfactory to the Director that the registrant has the licensure or registration required pursuant to § 1903.16.

1903.22

In the case of a withdrawal that is effective immediately, the registrant may seek reinstatement of the registration by submitting proof satisfactory to the Director that the registrant no longer poses a danger to the public health, safety, or welfare.

1903.23

In addition to any other appropriate remedies or actions, the Director may fine, suspend, or withdraw the registration of a registrant that violates the pharmacy or drug laws or regulations of the state in which it is located, the District of Columbia, or the United States; or causes harm or injury to a person in the District of Columbia.

1903.24

A registrant shall be afforded notice and, upon written request received by the Director within thirty (30) days of the receipt of the notice, an opportunity to be heard prior to the Director taking action pursuant to § 1903.19 against the registrant.

1903.25

Once a registration has been withdrawn, a registrant shall not ship, mail, or deliver in any manner, prescription drugs or medical devices into the District of Columbia, whether directly or indirectly.

1903.26

Upon receipt of a complaint against the nonresident pharmacy, the Department shall forward the complaint to the state where the nonresident pharmacy is located.

1903.27

The Department will extend reciprocal cooperation to any state that licenses or registers nonresident pharmacies for the purpose of investigating complaints against pharmacies located in the District of Columbia or the sharing of information and investigative reports, as long as the other state will extend the same reciprocal cooperation to the Department.

D.C. Mun. Regs. tit. 22, r. 22-B1903

Final Rulemaking published at 38 DCR 6734, 6735 (November 8, 1991); as amended by Notice of Final Rulemaking published at 55 DCR 270 (January 11, 2008); amended by Final Rulemaking published at 69 DCR 2763 (4/1/2022)