8399.1 As used in this Chapter the following terms shall have the meanings ascribed:

Act - 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-XXX, dated May XX, 2008.

Applicant - a person applying for a license to practice pharmacy under this chapter.

Board - the Board of Pharmacy, established by § 208 of the Act, D.C. Official Code § 3-1202.08.

Department - Department of Health

Director - Director of the Department

District of Columbia Family Medical Leave Act - District of Columbia Family Medical Leave Act of 1990, effective October 3, 1990 (D.C. Law 8-181; D.C. Official Code § 32-501 et seq.)

Family Medical Leave Act - Family Medical Leave Act of 1993, approved February 5, 1993 (107 Stat. 7; 29 U.S.C. § 2601 et seq.)

FDA - the federal Food and Drug Administration

HORA - Health Occupations Revision Act of 1985, effective March 25, 1986 (D.C. Law 6-99; D.C. Official Code § 3-1201.01 et seq.) Institution of Higher Education- as defined in § 101 of the Higher Education Act of 1965, as amended, approved October 7, 1998 (112 Stat. 1581; 20 U.S.C. § 1001).

Labeler - An entity or person that receives pharmaceutical products from a manufacturer or wholesaler and repackages those pharmaceuticals for later retail sale and that has a labeler code from the federal Food and Drug Administration under 21 C.F.R. § 207.20.

Manufacturer - a manufacturer of pharmaceutical products and includes subsidiary or affiliate of a manufacturer.

Marketing Representative - an individual who is employed by or is under contract to represent a manufacturer or labeler and engages in the marketing of pharmaceutical products in the District to any person or entity licensed to provide health care in the District.

Medication Advisory Committee - any committee or panel that is responsible for making recommendations or decisions regarding a formulary to be used by a health program administered by the government of the District of Columbia.

Pharmaceutical Company - any entity that is engaged in, either directly or indirectly, the production, preparation, propagation, compounding, manufacturing, conversion or processing of a drug or biologic product, including any person acting as its agent or representative.

Pharmaceutical Product - a drug or biologic regulated by the federal Food and Drug Administration.

Practice of Pharmaceutical detailing - the practice by a representative of a pharmaceutical manufacturer or labeler of communicating in person with a licensed health professional, or an employee or representative of a licensed health

SOURCE: Final Rulemaking published at 55 DCR 9317 (August 29, 2008).