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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-B4. DRUG MANUFACTURE AND DISTRIBUTION |
Section 22-B499. DEFINITIONS
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499.1When used in this chapter, the following words or phrases shall have the meanings ascribed:
Act - the District of Columbia Drug Manufacture and Distribution Licensure Act of 1990, D.C. Code, 2001 Ed. § 48-701 to 48-715.
Conditional License - a license issued pursuant to specific conditions.
Controlled Substance - a drug, substance, or immediate precursor, as defined under D.C. Code, 2001 Ed. § 48-902.02.
Department - the Department of Consumer and Regulatory Affairs.
Director - the Director of the Department of Consumer and Regulatory Affairs or a designee.
Distribute - to negotiate a sale or sell any drug for resale; or to act as a broker, agent, distributor, jobber, or wholesaler of any drug.
Drug - any substance as defined under D.C. Code, 2001 Ed. § 47-2885.02.
Manufacture - to prepare, produce, propagate, compound, convert, process, or package a drug, either directly or indirectly, by extraction from a substance of natural origin, or independently by means of chemical synthesis; any packaging or repackaging of the substance or drug; labeling or relabeling of any drug package or container to further distribution from the original place of manufacture to the person who makes final delivery, distribution, or sale to the ultimate consumer or user. Does not include the preparation or compounding of a drug by a pharmacist, practitioner, or any other authorized person who prepares or compounds a drug incidental to administering or dispensing a drug or conducting research, teaching, or chemical analysis on a drug in the course of professional practice.
Wholesaler - any person, including but not limited to, a manufacturer, repackager, own-label distributor, jobber, broker, agent, pharmacy, private label distributor, distributor warehouse, wholesale drug warehouse, independent wholesale drug trader, chain drug warehouse, retail pharmacy, or pharmacy that sells more than five percent (5%) of its drug inventory to a hospital or other pharmacy, which distributes a drug to a person other than a consumer or patient.