Preserving Patient Access to Compounded Medications Act of 2017
This bill amends the Federal Food, Drug, and Cosmetic Act to expand the circumstances under which a drug may be compounded (manufactured at small scale) to allow pharmacists and physicians to compound drugs for administration to patients in an office or clinical setting, in accordance with state law. (Drugs that are compounded do not need to meet certain federal requirements regarding manufacturing, labeling, or approval.)
Dietary supplements may be used in the compounding of a drug.
The bill exempts from interstate distribution limits the dispensing of a compounded drug from the facility where it is compounded to a patient or health facility.
The scope of Food and Drug Administration (FDA) inspections of compounding pharmacies is limited to pertinent equipment, materials, containers, and labeling, which is the same scope as inspections of pharmacies. (Currently, the scope of inspections of compounding pharmacies is the same scope as inspections of drug manufacturers.)
The bill eliminates the requirement for compounding pharmacies to register with the FDA as drug manufacturers.
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