Search Results for drug compounding

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BIO, PhRMA and Others Urge Further FDA Clarity on Drug Compounding By Zachary Brennan - Published 14 June 2017

The Biotechnology Innovation Organization (BIO), the Pharmaceutical Research and Manufacturers of America (PhRMA), Pew Charitable Trusts and other groups earlier this week sent letters to the House and Senate urging further support for FDA oversight of drug compounders and enforcement of the 2013 Drug Quality and Security Act. 

Categories: News, US, FDA, Compliance, Drugs, Government affairs

Tags: drug compounding, PhRMA, BIO, Pew Charitable Trusts, DQSA

GAO Survey of State Regulation of Drug Compounding Offers Mixed Results By Zachary Brennan - Published 31 March 2017

Among the local drug compounding regulators for 50 states, Washington, DC, Guam, Puerto and the US Virgin Islands, many say they are working with and appreciate the help of the US Food and Drug Administration (FDA), but only seven out of 50 respondents could differentiate all data on drug compounding for human use versus animal use.

Categories: News, US, FDA, Drugs

Tags: GAO, drug compounding, regulation of drug compounders

Drug Compounding With Bulk Substances: FDA Offers Interim Policies By Zachary Brennan - Published 16 January 2017

The US Food and Drug Administration (FDA) late Friday issued revised versions of two final guidance documents explaining the use of bulk drug substances in compounding and clarifying that the agency does not intend to take action against certain outsourcing facilities and compounded drugs.

Categories: News, US, FDA, Active pharmaceutical ingredients, Crisis management, Drugs, Quality

Tags: drug compounding, compounded drugs, 503A, 503B, FDA interim policy

FDA Proposes New Rule on Bulk Substances Used to Compound Drugs By Zachary Brennan - Published 15 December 2016

The US Food and Drug Administration (FDA) on Thursday issued a proposed rule that looks to add six bulk drug substances to a list of such substances that can be used in compounding and to remove four other bulk drug substances that FDA evaluated and should not be included in the list.

Categories: News, US, FDA, Active pharmaceutical ingredients, Crisis management, Drugs, Manufacturing, Quality

Tags: drug compounding, 503A bulks list, bulk drug substances, APIs

GAO Report Highlights Ongoing Challenges in Oversight of Drug Compounders By Michael Mezher - Published 18 November 2016

A new report by the Government Accountability Office (GAO) finds that while the US Food and Drug Administration (FDA) has taken steps to improve its oversight of drug compounders, challenges at both the state- and FDA-level remain.

Categories: News, US, FDA, Communication, Drugs, Manufacturing

Tags: Drug Compounding, Outsourcing Facility, Government Accountability Office, GAO

FDA to Drug Compounders: Inspection Changes Coming in August By Zachary Brennan - Published 12 July 2016

The US Food and Drug Administration (FDA) on Tuesday announced major changes with respect to inspections of drug compounders as infections linked to poor quality drugs continue to crop up.

Categories: News, US, FDA, Drugs, Government affairs, Manufacturing, Quality

Tags: drug compounding, FDA inspections, drug compounder quality

FDA to Restrict Compounders from Making Copies of Commercially Available Drugs By Zachary Brennan - Published 07 July 2016

The US Food and Drug Administration (FDA) on Thursday issued two draft guidance documents describing how the agency will restrict the compounding of drugs that are essentially copies of commercially available or approved drugs.

Categories: News, US, FDA, Active pharmaceutical ingredients, Generic drugs, Over the counter drugs, Prescription drugs, Manufacturing, Quality

Tags: drug compounding, FDA guidance on compounding

Three New FDA Draft Guidance Documents for Drug Compounders By Zachary Brennan - Published 15 April 2016

On Friday, the US Food and Drug Administration (FDA) released three draft guidance documents for drug compounders.

Categories: News, US, FDA, Crisis management, Drugs, Manufacturing, Postmarket surveillance

Tags: drug compounding, hospital pharmacists

Two-Day FDA Advisory Committee Meeting to Address Drug Compounding Questions By Zachary Brennan - Published 30 September 2015

The US Food and Drug Administration (FDA) will host a two-day public advisory committee meeting on 27 and 28 October to look into updating a list of bulk drug substances that should not be compounded, and another list of substances that can be compounded.

Categories: News, US, FDA, Generic drugs, Prescription drugs, Government affairs, Manufacturing, Postmarket surveillance, Quality, Regulatory intelligence, Regulatory strategy

Tags: drug compounding, fungal meningitis, Pharmacy Compounding Advisory Committee, quinacrine hydrochloride