Chemical companies may place a disclaimer on their chemicals for a number of reasons,
including the following:
Companies do not want to be required to label the materials under the Food, Drug, and Cosmetic Act of 1938 (FDC Act); consequently, they state that the materials are not to be used as drugs. This exempts the companies from having to comply with the FDC regulations.
The source of the chemicals may be companies that do not meet current good manufacturing practices as stipulated in parts 210 and 211 of the Code of Federal Regulations; thus, when drugs are repackaged, only select information concerning the levels of potency and impurities and other miscellaneous characterization data are provided.
The disclaimer protects the companies from liability associated with the use of their products that have not undergone the full safety and effectiveness testing required by FDA for the manufacturing of drug products.
The pharmacist is responsible for compounding preparations of acceptable ...Pharmacists should not offer compounded medications to other pharmacies for.
Companies do not want to be required to label the materials under the Food, Drug, and Cosmetic Act of 1938 (FDC Act); consequently, they state that the materials are not to be used as drugs. This exempts the companies from having to comply with the FDC regulations.
The source of the chemicals may be companies that do not meet current good manufacturing practices as stipulated in parts 210 and 211 of the Code of Federal Regulations; thus, when drugs are repackaged, only select information concerning the levels of potency and impurities and other miscellaneous characterization data are provided.
The disclaimer protects the companies from liability associated with the use of their products that have not undergone the full safety and effectiveness testing required by FDA for the manufacturing of drug products.
Quoted from: Guidelines for Compounding Practices - American ...
www.pharmacist.com/.../Allen_%20Ch...
American Pharmacists Association
Last visit: 4/13/15
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