D.C. Mun. Regs. tit. 22, r. 22-B10207

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

Rule 22-B10207 - REFUSAL, CANCELLATION, SUSPENSION, OR REVOCATION OF LICENSE

10207.1

The Director may refuse an application or may refuse to license an applicant, or, suspend or revoke a license , after providing the applicant or licensee with an opportunity for a hearing, if the applicant or licensee:

(a) Has been convicted of a felony or misdemeanor that involves moral turpitude;

(b) Is an association, partnership, or corporation whose managing officer has been convicted of a felony or misdemeanor that involves moral turpitude;

(c) Has been convicted in a District of Columbia or federal court of the illegal use, sale, or transportation of intoxicating liquors, narcotic drugs, barbiturates, amphetamines, desoxyephedrine, their compounds or derivatives, or any other dangerous or habit-forming drugs;

(d) Is an association, partnership, or corporation whose managing officer has been convicted in the District of Columbia Superior Court or federal court of the illegal use, sale or transportation of intoxicating liquors, narcotic drugs, barbiturates, amphetamines, desoxyephedrine, their compounds or derivatives, or any other dangerous or habit-forming drugs;

(e) Has violated any of the provisions of D.C. Official Code §§ 48-904.01, et seq. (2009 Repl.);

(f) Has failed to pay a license fee or a renewal fee for a license; or

(g) Has obtained or attempted to obtain a license by fraud or deception.

10207.2

The Director may refuse to license an applicant, or, suspend or revoke a license if the Director determines from evidence presented during a hearing that the applicant or licensee:

(a) Has violated any provisions of the District of Columbia Official Code, §§ 22 -901, et seq. concerning the counterfeiting of a drug or the sale or holding for sale of a counterfeit drug;

(b) Has violated D.C. Official Code §§ 48-904.01, et seq.; or

(c) Has violated any of these regulations, including being responsible for a significant discrepancy in the records that District law requires the applicant or licensee to maintain.

10207.3

The Department may, after providing opportunity for a hearing, refuse to license a distributor, manufacturer, initial importer, or vendor of medical devices, or may suspend or revoke a license, for any violation of the federal-law requirements incorporated into these regulations pursuant to § 10201.

10207.4

A license issued under this chapter shall be returned to the Department if the medical device distributor, manufacturer, initial importer, or vendor's place of business:

(a) Ceases business or otherwise ceases operation on a permanent basis;

(b) Relocates; or

(c) Is deemed, as a corporation, to have undergone an ownership change as determined by a transfer of five percent (5%) or more of the share of stock from one person to another.

D.C. Mun. Regs. tit. 22, r. 22-B10207

Final Rulemaking published at 60 DCR 10252 (July 12, 2013); amended by Final Rulemaking published at 63 DCR 13491 (10/28/2016)

Authority: Section 19(a)(3) of the District of Columbia Pharmacist and Pharmacy Regulation Act of 1980, effective September 16, 1980 (D.C. Law 3-98; D.C. Official Code § 47-2885.18(a)(3) (2005 Repl.)); Mayor's Order 98-48, dated April 15, 1998; Section 4902 of the Fiscal Year 2002 Budget Support Act of 2001, effective October 3, 2001 (D.C. Law 14-28; D.C. Official Code § 7-731 (2008 Repl.)); Section 15 of the District of Columbia Medical Device Manufacture and Distribution Licensure Act of 1990, effective June 13, 1990 (D.C. Law 8-137; D.C. Official Code § 48-714(a) (2005 Repl.)); and Mayor's Order 98-88, dated May 29, 1998.