3.0.0 1406 2023-01-11T13:31:05Z 2023-01-11T13:31:05Z Senate S 2015-05-20 114 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2015-05-20T23:02:33Z 2015-05-20 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2015-05-20 Introduced in Senate IntroReferral 10000 9 Library of Congress V000127 Sen. Vitter, David [R-LA] David Vitter R LA N Health Drug safety, medical device, and laboratory regulation Prescription drugs Health 00 2015-05-20 Introduced in Senate 2015-11-16T20:20:44Z 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.)]]> Saving Access to Compounded Medications for Special Needs Patients Act Display Title Saving Access to Compounded Medications for Special Needs Patients Act Official Title as Introduced A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to pharmacy compounding. Introduced in Senate IS Short Titles as Introduced Saving Access to Compounded Medications for Special Needs Patients Act Introduced in Senate 2015-05-20T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-114s1406is/xml/BILLS-114s1406is.xml 2015-05-20 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.