Bioidentical Hormones - U.S. Senate Special Committee on Aging

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adulteration and misbranding provisions of the FD&C Act do not contain exemptions for
compounded drugs.
To facilitate enforcement of the approval, adulteration, misbranding, and other FD&C
Act provisions, Congress has authorized FDA to enter "any . .. establishment" where
drugs are "manufactured, processed, packed, or held" and to inspect such establishments
and "all pertinent equipment, finished and unfinished materials, containers, and labeling
therein." Id. §374(a)(1). This authority extends to "all things" in these establishments,
including records relating to prescription drugs. Id. The statute provides an exemption
from records inspection for pharmacies that comply with local pharmacy law and that
satisfy other criteria. But there is no specific exemption from inspection for
compounding pharmacies or compounded drugs.
The 1992 Compliance Policy Guide on Compounding
FDA has long interpreted the FD&C Act to apply to compounded drugs, including the
provisions addressing new drug approval requirements, adulteration, and misbranding.
However, FDA has historically exercised its discretion to exempt from enforcement
pharmacists engaged in traditional compounding.
In March 1992, responding to a significant increase in pharmacy compounding, FDA
issued a compliance policy guide (CPG), section 7132.16 (later renumbered as 460.200)
to delineate FDA's enforcement policy on pharmacy compounding. This CPG relied on
enforcement discretion, rather than legal exemptions from the FD&C Act's new drug
approval and other requirements, to guide FDA's regulatory approach. After Congress
enacted the Food and Drug Administration Modernization Act of 1997 to specifically
address FDA's role in the regulation of pharmacy compounding, the 1992 CPG was
rescinded.
Food and DruE Administration Modernization Act of 1997
The Food and Drug Administration Modernization Act added section 503A to the FD&C
Act to clarify the status of pharmacy compounding and compounded drugs under Federal