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H.R. 2871 · 115th Congress

Preserving Patient Access to Compounded Medications Act of 2017

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Never voted on. It didn't reach a floor vote before the 115th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.

Preserving Patient Access to Compounded Medications Act of 2017

What it does: CRS summary · Introduced in House · Jun 12, 2017

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.

Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov

About this bill and sources

Official title: Preserving Patient Access to Compounded Medications Act of 2017

Latest action (Jun 16, 2017): Referred to the Subcommittee on Health.

Policy area: Health · Origin: House · Introduced: Jun 12, 2017

Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)

No recorded floor vote found.