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WHAT DIFFERENTIATES USP AND FOOD GRADE GLYCERIN FROM TECHNICAL GRADE GLYCERIN?

Glycerin USP is closely regulated by FDA in all aspects of manufacturing, testing, inspection, distribution, and warehousing. Glycerin USP is subject to FDA rules requiring registration and listing, and glycerin FCC as well as USP are also subject to Good Manufacturing Practices, a series of appropriate procedures prescribed by FDA, while the technical grade is not under such regulatory control.

FDA requires all domestic owners or operators of all establishments that manufacture or process glycerin USP to register and list, unless specifically exempted (21CFR §207.20). For glycerin USP of foreign origin, the foreign manufacturer and the importer share the responsibility of FDA compliance (21CFR§207.4). The Agency’s definition of "manufacturer" includes the original producer as well as re-packagers and/or distributors (21CFR§207.4). Additional information on drug registration and listing instructions is available from FDA at http://www.fda.gov/cder/drls/introduc.htm#top.

Further, under FDA regulations, the quality and purity of USP and FCC glycerin products must be supported by systematic and complete record keeping on the part of the manufacturer. For example, every shipment of USP and FCC glycerin must be referenced to a lot number, which permits tracing back to the plant in which the product was produced. These requirements are designed to assure a level of product integrity that cannot be achieved strictly by reliance only on physical and chemical testing.

Technical grades of glycerin, on the other hand, are not subject to the same FDA regulatory oversight. Although produced by similar processes, the technical grades of glycerin do not have to comply with USP and FCC requirements or with FDA regulations. This quality grade of glycerin must conform only to the specifications and terms agreed upon in the transaction between buyer and seller.

Next: WHAT ARE SOME OF THE KEY PRACTICES THAT MUST BE FOLLOWED TO ASSURE THAT GLYCERIN WILL MEET USP AND FCC REQUIREMENTS?