D.C. Mun. Regs. tit. 17, r. 17-8300

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

Rule 17-8300 - GENERAL PROVISIONS

8300.1

Effective, October 1, 2008, this chapter shall apply to applicants for and holders of a license to practice pharmaceutical detailing.

8300.2

Effective April 1, 2009, a person shall be licensed under the Act before the individual may practice pharmaceutical detailing in the District of Columbia.

8300.3

A person who practices pharmaceutical detailing in the District of Columbia without a license shall be subject to a fine of up to ten thousand dollars ($10,000.00) in addition to the other penalties and sanctions set forth in the Act and the HORA.

8300.4

Chapters 40 (Health Occupations: General Rules), and 41 (Health Occupations: Administrative Procedures) of this title shall supplement this chapter.

8300.5

For purposes of this chapter, an individual shall be deemed as engaging in the practice of pharmaceutical detailing if:

(a) He or she is acting as a representative of a pharmaceutical manufacturer or labeler; and

(b) Communicating in person with a licensed health professional or an employee or representative of a licensed health professional located in the District of Columbia;

(c) In a non-conference setting, as defined in this chapter;

(d) For the purpose of selling, marketing, or promoting a prescription or over-the-counter pharmaceutical product for use in humans, or providing information about a pharmaceutical product for the purpose of selling, marketing, or promoting such product.

8300.6

The scope of this chapter shall not apply to representatives who only sell, market, or promote veterinary drugs.

8300.7

The scope of this chapter shall not apply to the act of providing information about a pharmaceutical product solely for the purpose of conducting or pertaining to clinical trials, investigational drugs, or a Risk Evaluation and Mitigation Strategy pursuant to the Federal Food, Drug and Cosmetic Act.

8300.8

The scope of this chapter shall not apply to activities taking place at a conference, as defined in this chapter.

8300.9

The scope of this chapter shall not apply to health professionals participating in a conference, as defined in this chapter, including conferences targeting a local audience, solely as a speaker or presenter with respect to his or her area of expertise.

D.C. Mun. Regs. tit. 17, r. 17-8300

Final Rulemaking published at 55 DCR 9317 (August 29, 2008); as amended by Final Rulemaking published at 56 DCR 2951 (April 17, 2009)

Authority: Pursuant to the District of Columbia Health Occupations Revision Act of 1985, effective March 25, 1986 (D.C. Law 6-99; D.C. Official Code § 3-1203.02(14) ), Mayor's Order 98-140, dated August 20, 1998, the SafeRx Amendment Act of 2008, effective March 26, 2008 (D.C. Law 17-0131; 55 DCR 4462, published on April 25, 2008) (the Act), and Mayor's Order 2008-94, dated July 3, 2008.