D.C. Mun. Regs. tit. 22, r. 22-B1902

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

Rule 22-B1902 - NEW LICENSURE OF PHARMACIES

1902.1

Licenses shall be issued for the following categories of pharmacies as defined in this chapter, except for non-resident pharmacies, which shall be required to register with the Department:

(a) Retail pharmacy/community pharmacy;

(b) Nuclear pharmacy;

(c) Institutional pharmacy;

(d) Special or limited use pharmacy; and

(e) Non-resident pharmacy.

1902.2

A retail chain pharmacy with locations both in and outside of the District of Columbia shall obtain:

(a) A license for each location within the District of Columbia; and

(b) A registration pursuant to § 1903 for each location outside the District of Columbia which dispenses, distributes, ships, mails, or delivers, in any manner, prescription drugs or prescription medical devices directly or indirectly to a patient in the District of Columbia.

1902.3

The Director shall not license or register a pharmacy, person, or entity, which serves as a storefront, broker, agent, dealer, or in any way exists to facilitate the dispensing, shipping, mailing, delivery, or distribution of prescription drugs or devices from Canada, or any other jurisdiction outside of the United States, to District of Columbia residents.

1902.4

Except as otherwise provided in this chapter, an applicant for a new license to operate a pharmacy shall furnish proof satisfactory to the Director of the following:

(a) That a valid certificate of occupancy, where required by the Department of Consumer and Regulatory Affairs, has been issued for the premises where the pharmacy will be located;

(b) If the pharmacy is owned by a corporation, that the corporation is in good standing with the District of Columbia, or the state of incorporation if the pharmacy is incorporated in a state other than the District of Columbia;

(c) That each person listed on the application (individuals, partners, or officers of the corporation) has not been convicted of a felony involving drugs;

(d) Whether the pharmacy intends to engage in the compounding of sterile pharmaceuticals; and

(e) Other information as may be necessary to properly evaluate the applicant and the application.

1902.5

It shall be unlawful for any person to furnish false or fraudulent information on an application for a license or registration.

1902.6

The application for a pharmacy license shall be made on a form to be prescribed by the Director and shall include the required fee. No license fee shall be required for the operation of a pharmacy by the United States government or by the District of Columbia government.

1902.7

The application for a pharmacy license shall include the name and license number of the licensed pharmacist who shall be responsible for ensuring that the pharmacy complies with all applicable laws and regulations pertaining to the operation of the respective pharmacy and practice of pharmacy. The pharmacist shall be known as:

(a) The "pharmacist-in-charge" for a retail/community pharmacy, special or limited use pharmacy, or non-resident pharmacy;

(b) The "Director of Pharmacy" for an institutional pharmacy; and

(c) The "Responsible Nuclear Pharmacist" for a nuclear pharmacy.

1902.8

The proprietor of a pharmacy, or other appropriate individual, shall notify the Director within thirty (30) days after a change in the pharmacist-in-charge, Director of Pharmacy, or Responsible Nuclear Pharmacist.

1902.9

Prior to issuing a license, the Director shall make an inspection of a pharmacy to determine compliance with the Act and this chapter.

1902.10

The Director shall send a written report of the findings of the inspection to the licensee no later than fifteen (15) days after the conclusion of the inspection.

1902.11

The Director shall issue a license to a pharmacy that the Director determines is in compliance with the Act and this chapter.

1902.12

The Director shall indicate on the face of the license:

(a) The pharmacy classification for which the license is issued; and

(b) Any restrictions on the license for special or limited use pharmacies.

1902.13

A license is valid only for the proprietor, the premises, and the pharmacy name designated on the license and the location for which it is issued.

1902.14

A pharmacy license is not transferable.

1902.15

The pharmacy license shall be issued in the name of the proprietor whether or not the proprietor of a pharmacy is a pharmacist.

1902.16

A license is the property of the District of Columbia government and shall be returned to the Director immediately upon the occurrence of any of the following events:

(a) Suspension or revocation of the license;

(b) Refusal or failure to renew the license;

(c) Voluntary surrender by the licensee;

(d) Change in proprietorship of the pharmacy;

(e) Death of the proprietor;

(f) Failure of the pharmacy to open for business within thirty (30) days after the license has been issued, except that the Director may grant an extension at his or her discretion for good cause shown;

(g) Failure of the pharmacy to operate for any reason for more than ninety (90) consecutive days after it has opened for business; or

(h) Closure of the pharmacy.

1902.17

The term of a license issued or renewed pursuant to this chapter is two (2) years 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 § 1902.18.

1902.18

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

1902.19

If the Director changes the renewal system pursuant to § 1902.18 of this chapter, the term of a license 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.

D.C. Mun. Regs. tit. 22, r. 22-B1902

Final Rulemaking published at 38 DCR 6734 (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)