US SB1406 | 2015-2016 | 114th Congress

Status

Sponsorship: Partisan Bill (Republican 1)
Status: Introduced on May 20 2015 - 25% progression, died in committee
Action: 2015-05-20 - Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Pending: Senate Health, Education, Labor, And Pensions Committee
Text: Latest bill text (Introduced) [PDF]

Summary

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.)

Tracking Information

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Title

Saving Access to Compounded Medications for Special Needs Patients Act

Sponsors


History

DateChamberAction
2015-05-20SenateRead twice and referred to the Committee on Health, Education, Labor, and Pensions.

Subjects


US Congress State Sources


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