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Producers

IMPORTANT DEFINITIONS:

"Covered Drug'' means a Drug sold in any form and used by County residents, including prescription, nonprescription, brand name, and generic drugs. Notwithstanding the previous sentence, "Covered Drug" does not include: (1) vitamins or supplements; (2) herbal-based remedies and homeopathic drugs, products, or remedies; (3) cosmetics, shampoos, sunscreens, toothpaste, lip balm, antiperspirants, or other personal care products that are regulated as both cosmetics and nonprescription drugs under the federal Food, Drug, and Cosmetic Act (Title 21 U.S.C. Chapter 9); (4) drugs for which Producers provide a pharmaceutical product stewardship or take-back program as part of a federal Food and Drug Administration-managed  risk evaluation and mitigation strategy (Title 21 U.S.C. Sec. 355-1); (5) drugs that are biological products as defined by 21 C.F.R. 600J(h) as it exists on the effective date of this Chapter if the Producer already provides a pharmaceutical product stewardship or take-back program; and (6) medical devices or their component parts or accessories.
 
"Producer" means a Manufacturer engaged in the Manufacture of a Covered Drug sold in the County, including a brand-name or generic Drug. Notwithstanding the previous sentence, "Producer" does not include: (1) a retailer whose store label appears on a Covered Drug or the drug's packaging if the Manufacturer from whom the retailer obtains the drug is identified under Section B 11-541(e) of this Chapter; (2) a Repackager if the Manufacturer from whom the Repackager obtains the Drug is identified under SectioB11-54 l(e) of this Chapter; (3) a pharmacist who compounds or repackages a prescribed individual drug product for a consumer; or (4) a wholesaler who is not also the Manufacturer.



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