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S. 1406 · 114th Congress

Saving Access to Compounded Medications for Special Needs Patients Act

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Never voted on. It didn't reach a floor vote before the 114th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.

No cosponsors.

Saving Access to Compounded Medications for Special Needs Patients Act

What it does: CRS summary · Introduced in Senate · May 20, 2015

Saving Access to Compounded Medications for Special Needs Patients Act

This bill amends the Federal Food, Drug, and Cosmetic Act to allow drugs to be compounded (manufactured at a small scale) and distributed to practitioners for treatment of, or administration to, patients of that practitioner. Currently, drugs may be compounded only for identified individual patients. (Compounded drugs do not need to meet certain requirements for drugs regarding manufacturing, labeling, or FDA approval.)

Compounded drugs must comply with United States Pharmacopeia standards.

A memorandum of understanding (MOU) between the FDA and a state regarding compounded drugs no longer must address interstate distribution of inordinate amounts of compounded drugs. Such an MOU must not create an unfunded mandate on a state. (Compounders in states that do not have an MOU with the FDA may not distribute more than 5% of their orders out of state.)

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

About this bill and sources

Official title: Saving Access to Compounded Medications for Special Needs Patients Act

Latest action (May 20, 2015): Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Policy area: Health · Origin: Senate · Introduced: May 20, 2015

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

No recorded floor vote found.