Search Results for Pharmaceutical Compounding

Showing 1 – 25  of 33

NIH Suspends Drug Production Unit After FDA Inspection Finds Major Problems By Alexander Gaffney, RAC - Published 05 June 2015

Pharmaceutical companies frequently find themselves sanctioned by the US Food and Drug Administration (FDA) for failing to adhere to federal good manufacturing practice (GMP) requirements. But it's an exceptionally rare occurrence to see FDA cracking down on a fellow federal government agency, as it is this week.

Categories: News, US, FDA, Compliance, Crisis management, Drugs, Manufacturing

Tags: PDS, National Institutes of Health, Pharmaceutical Compounding, Form 483

FDA Considers Compounding Restrictions on Four Drugs, Including Acetaminophen By Alexander Gaffney, RAC - Published 21 May 2015

The US Food and Drug Administration (FDA) is preparing to ask one of its newest advisory committees to decide if some compounding pharmacies should be allowed to make four drugs, including the widely used painkiller acetaminophen.

Categories: News, US, CDER, Drugs

Tags: PCAC, Pharmacy Compounding Advisory Committee, Pharmaceutical Compounding, Compounding

FDA Releases Long-Awaited Policies on Regulation of Pharmaceutical Compounders By Alexander Gaffney, RAC - Published 13 February 2015

The US Food and Drug Administration (FDA) has announced the release of four guidance documents intended to help increase regulatory oversight of the pharmaceutical compounding industry.

Categories: News, US, CDER, Drugs, Labeling, Manufacturing, Packaging

Tags: Pharmaceutical Compounding, Compounding, Guidance, Draft Guidance

FDA Committee Prepares to Decide if Six Drugs Can be Made by Compounding Pharmacies By Alexander Gaffney, RAC - Published 23 January 2015

The US Food and Drug Administration (FDA) has announced it will soon hold the first meeting of a new and influential advisory committee that is set to make recommendations about which drugs will not be allowed to be made by compounding pharmacies in the US.

Categories: News, US, CDER, Drugs, Postmarket surveillance

Tags: PCAC, Pharmaceutical Compounding, Advisory Committee, Pharmaceutical Compounding Advisory Committee

In FDA Effort to Strengthen Regulation of Compounded Drugs, Protections and Profits Intersect By Alexander Gaffney, RAC - Published 04 September 2014

A new law meant to protect consumers from unsafe pharmaceutical compounding practices is drawing interest from pharmaceutical companies, who are petitioning the US Food and Drug Administration (FDA) to add some of their products to a new list of restricted drugs that could protect patients from deficient drugs—and likely companies from compounded competition as well.

Categories: News, US, CDER, Drugs, Manufacturing, Regulatory strategy

Tags: 503A 503B, Pharmaceutical Compounding, Compounding, DQSA, Drug Quality and Security Act, Difficult-to-Compound List

Laminated Particleboard not a Great Idea for Sterile Compounding, FDA says in Warning Letter By Alexander Gaffney, RAC - Published 22 July 2014

Pharmaceutical compounders, take note: The US Food and Drug Administration (FDA) wants you to stop using laminated particleboard in your aseptic processing areas.

Categories: News, US, CDER, Compliance, Drugs, Quality

Tags: Pharmaceutical Compounding, Compounding, Sterile Compounding, ISO 5, Cleanroom, Asceptic, Aseptic, Particleboard, Warning Letter

DHHS Signs Over (a Little Bit of) Compounding Oversight Authority to FDA By Alexander Gaffney, RAC - Published 23 April 2014

Categories: US, FDA

Tags: Delegated Authority, DQSA, Pharmaceutical Compounding, Compounding, Latest News, Authority, DHHS

Warning Letter Resurrects Issue of Makena and FDA's Use of Enforcement Discretion By Alexander Gaffney, RAC - Published 13 March 2014

Categories: US, FDA

Tags: Pharmaceutical Compounding, Makena, Compounding Pharmacy, Compounding, warning letter, Latest News

FDA Warns Three Compounding Pharmacies for Unsanitary Conditions By Alexander Gaffney, RAC - Published 04 March 2014

Categories: US, FDA

Tags: DQSA, Pharmaceutical Compounding, Compounding Pharmacy, Compounding, warning letter, Latest News

Hamburg Takes Peer-Pressure Approach in Advocating for Safer Compounding Practices By Alexander Gaffney, RAC - Published 10 January 2014

Categories: US, FDA, CDER

Tags: Pharmaceutical Compounding, Compounding Pharmacy, Compounding, Margaret Hamburg

As Compounding Framework Takes Shape, So Does Influential Advisory Committee By Alexander Gaffney, RAC - Published 10 January 2014

Categories: US, FDA

Tags: Difficult-to-Compound, Pharmaceutical Compounding, Compounding Pharmacy, Compounding

Legislator: Expect FDA Regulation to Stay Under the Microscope in 2014 By Alexander Gaffney, RAC - Published 06 January 2014

Categories: US, FDA

Tags: DQSA, Pharmaceutical Compounding

FDA Prepares Compounding Blacklist of Banned Products By Alexander Gaffney, RF News Editor - Published 03 December 2013

Categories: US, FDA

Tags: Difficult-to-Compound, Pharmaceutical Compounding, Compounding Pharmacy, Compounding, Latest News

As FDA Begins to Implement DQSA, Questions About Enforcement Discretion go Unanswered By Alexander Gaffney, RF News Editor - Published 03 December 2013

Categories: US, FDA

Tags: Pharmaceutical Compounding, Compounding Pharmacy, Compounding

FDA Releases Trio of Compounding Guidances Just Days After DQSA Signed into Law By Alexander Gaffney, RF News Editor - Published 02 December 2013

Categories: US, FDA

Tags: Drug Quality and Security Act, DQSA, Pharmaceutical Compounding, Compounding, Legislation, Latest News, draft guidance

Track and Trace, Compounding Legislation Passes Senate, Awaits President's Signature By Alexander Gaffney, RF News Editor - Published 18 November 2013

Categories: US, FDA

Tags: Drug Quality and Security Act, DQSA, Pharmaceutical Compounding, Compounding, Track and Trace, Legislation, Latest News

Public Safety Concerns Support FDA Call for Compounding Pharmacy Regulation By Rachel A. Hardy, MA, RAC - Published 23 September 2013

Both the US Food and Drug Administration (FDA) and state authorities play a role in regulating compounding pharmacies. However, because the lines of authority are poorly delineated, facility oversight is inadequate. To increase public trust in the drug supply, new regulatory solutions must be considered.

Categories: Features, US, FDA

Tags: Pharmaceutical Compounding, NECC, Meningitis, Compounding

Fallout from Deficient Contract Testing Facility Continues, Prompting Fourth Company to Issue Recall By Alexander Gaffney, RF News Editor - Published 06 September 2013

Categories: US, FDA

Tags: Pharmaceutical Compounding, Recall

Fallout from Deficient Testing Contractor Begins as Three Firms Issue Recalls By Alexander Gaffney, RF News Editor - Published 28 August 2013

Categories: US, FDA

Tags: Pharmaceutical Compounding, Compounding

Inspection of Contract Testing Lab Raises Product Quality Questions for Dozens of Companies By Alexander Gaffney, RF News Editor - Published 22 August 2013

Categories: US, FDA

Tags: Pharmaceutical Compounding, Compounding Pharmacy, Compounding

Australia Tackles Compounding Concerns By Louise Zornoza, RegLink - Published 06 June 2013

Categories: Regulatory Update, TGA

Tags: Pharmaceutical Compounding, Compounding, australia

Senate Advances Compounding, Track and Trace Legislation with an Eye on July Passage By Alexander Gaffney, RF News Editor - Published 23 May 2013

Categories: US

Tags: Pharmaceutical Compounding, Compounding, Track and Trace, User Fees, Legislation, Latest News, Senate

Woodcock: FDA Isn't Fully Aware of Compounding Problem's Scope By Alexander Gaffney, RF News Editor - Published 10 May 2013

Categories: US, FDA

Tags: Pharmaceutical Compounding, Compounding, HELP Committee, Latest News, Senate, Congress, pharmaceutical, drug

Compounding Pharmacy Chain Hit with Record Six Form-483s By Alexander Gaffney, RF News Editor - Published 06 May 2013

Categories: US, FDA

Tags: Pharmaceutical Compounding, Compounding Pharmacy, 483

New Compounding Legislation Borrows Heavily from FDA Framework, Will Include User Fees By Alexander Gaffney, RF News Editor - Published 26 April 2013

Categories: US, FDA

Tags: Pharmaceutical Compounding, Compounding, framework, User Fees, Legislation, Latest News