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D.C. Municipal Regulations (Last Updated: September 13, 2017) |
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Title 22. HEALTH |
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SubTilte 22-B. PUBLIC HEALTH AND MEDICINE |
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Chapter 22-B102. LICENSING OF MEDICAL DEVICES - DISTRIBUTORS, MANUFACTURERS, INITIAL IMPORTERS, AND VENDORS |
Section 22-B10207. REFUSAL, CANCELLATION, SUSPENSION, OR REVOCATION OF LICENSE
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10207.1The 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.
10207.2The 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.
10207.3The 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.
10207.4A 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.