8399. DEFINITIONS

8399 DEFINITIONS 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 pharmaceutical detailing under this chapter. Board - the Board of Pharmacy, established by § 208 of the Act, D.C. Official Code § 3-1202.08. Conference - (1) A meeting, symposium, exposition, exhibit, convention, assembly, or like gathering, including meetings of a regional, national, or international professional association, society, or body, for the discussion of health-related issues consisting of multi-pharmaceutical company or labeler representation and targeting a regional, national, or international audience; or (2) a scientific or medical educational meeting or symposium that is accredited by a nationally recognized healthcare professional education accreditation body (e.g., the Accreditation Council for Continuing Medical Education, the Accreditation Council for Pharmacy Education, and the American Nurses Association). 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. 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. Multi-pharmaceutical or labeler representation- at least three or more pharmaceutical companies or labelers which shall not be subsidiaries, or affiliations of the same company or parent company. 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 Detailer: a person licensed under the Act to engage in the practice of pharmaceutical detailing. 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 Sales Call- any in person communication with a health care professional or his or her employees or representatives for the direct purpose of selling marketing, or promoting a pharmaceutical product, or providing information about a pharmaceutical product for the purpose of selling, marketing, or promoting such pharmaceutical product on behalf of a pharmaceutical manufacturer or labeler. SOURCE: Final Rulemaking published at 55 DCR 9317 (August 29, 2008); as amended by Final Rulemaking published at 56 DCR 2951 (April 17, 2009); as amended by Final Rulemaking published at 57 DCR 5739, 5740 (July 2, 2010).