Saving Access to Compounded Medications for Special Needs Patients Act
Bill journey · stage 2 of 5
Under committee review
What it doesSummary 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.)What just happenedMay 20, 2015
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Who’s behind it
- Introduced in SenateMay 20, 2015
- May 20, 2015IntroReferral
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Health, Education, Labor, and Pensions Committee - May 20, 2015IntroReferral10000
Introduced in Senate