Searching Content indexed under Healthcare by Rachael Pontikes ordered by Published Date Descending.
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FDA Clarifies Its Position On Several Compounding Issues In New Draft Guidance Documents
On April 15, 2016, the U.S. Food and Drug Administration announced the release of three new draft guidance documents on drug compounding under Sections 503A and 503B of the Food, Drug, and Cosmetic Act.
United States
17 May 2016
Senate HELP Committee Releases Revised Senate Bill Providing Federal Oversight for Compounding Pharmacies
The Senate HELP Committee has released a revised draft Senate Bill ("Revised Senate Bill"), updating the committee's first proposed compounding bill and signaling the latest push for the U.S. Food and Drug Administration's (FDA) regulation of compounding pharmacies.
United States
30 Jul 2013
Congress Drafts Compounding Legislation -- Defines Compounded Drugs As "New Drugs" Under The FFDCA And Creates Bright Line Between "Traditional Compounders" And "Compounding Manufacturers"
In the wake of the New England Compounding Center meningitis outbreak, the federal government has actively pushed for greater legislative oversight over compounding pharmacies.
United States
5 May 2013
Compounding Animal Drugs From Bulk Ingredients
A discussion relating to the federal role in regulating compounding pharmacies has focused on compounded drugs for human use.
United States
22 Apr 2013
FDA Emphasizes Patient-Specific Prescriptions
The FDA's reliance on the compliance policy guide as a basis for the need for a patient-specific prescription is also noteworthy.
United States
31 Mar 2013
FDA Tightens Requirement For Patient-Specific Prescriptions In The Wake Of The Meningitis Outbreak
In a letter to compounding pharmacy PharMEDium, the U.S. Food and Drug Administration (FDA) stated it was no longer willing to accept an alternate method of satisfying the requirement for a patient-specific prescription.
United States
4 Mar 2013
U.S. Government’s Use Of The "Park Doctrine" To Police Pharmacies
Based on the current public scrutiny that compounding pharmacies are under due to the outbreak of fungal meningitis in Massachusetts, pharmacy executives may want to review their internal procedures for compliance with the FDCA to ensure they are robust.
United States
8 Jan 2013
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