Search Results for Compounding

Showing 1 – 25  of 90

FDA Warns Compounding Pharmacy, Finds Wood in Drug Sample By Zachary Brennan - Published 22 August 2017

The US Food and Drug Administration (FDA) earlier this month sent a warning letter to a Folcroft, PA-based compounding drug facility run by ImprimisRx after uncovering adulterated products and insanitary conditions.

Categories: News, US, FDA, Compliance, Drugs

Tags: ImprimisRx, compounding drugs, compounding pharmacy

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

BIO, Pew Weigh FDA's Revised Draft Guidance on Mixing, Diluting or Repackaging Biologics By Michael Mezher - Published 15 March 2017

The Biotechnology Innovation Organization (BIO) and the Pew Charitable Trusts are offering their input on the US Food and Drug Administration's (FDA) recently revised draft guidance on mixing, diluting or repackaging biologics.

Categories: News, US, FDA, Biologics and biotechnology, Manufacturing, Packaging

Tags: Mixing, Diluting, Repackaging, Compounding, Outsourcing Facilities, BIO, Pew

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

New FDA Guidance Tackles Insanitary Conditions at Compounding Facilities By Michael Mezher - Published 03 August 2016

The US Food and Drug Administration (FDA) on Wednesday issued new draft guidance intended to help drug compounders address insanitary conditions at their facilities.

Categories: News, US, FDA, Biologics and biotechnology, Prescription drugs, Manufacturing

Tags: Compounding, Compounded drugs, Outsourcing Facility, Draft Guidance

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

Transparency: What FDA Drug, Device Regulations are Coming Later in 2016 By Zachary Brennan - Published 28 March 2016

As part of the US Food and Drug Administration's (FDA) overarching transparency initiative – what’s known as FDA Transparency Results Accountability Credibility Knowledge Sharing (TRACK) –  the agency offers a look at what to expect for upcoming proposed and final rulemakings, though the dates in the tracker do not necessarily guarantee the release of the rules.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Combination products, Compliance, Drugs, Government affairs, Labeling, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: FDA rules, FDA proposed rules, postmarketing studies of combo products, device labels, compounding drugs, OTC cold medicines

Researchers See Compounding, Imports as Fix for Pricey Off-Patent Drugs By Michael Mezher - Published 05 January 2016

Three Johns Hopkins researchers are calling on the US Food and Drug Administration (FDA) to take action on expensive off-patent drugs by permitting bulk compounding and importation of generic formulations of the drug that are approved in other countries.

Categories: News, US, FDA, Active pharmaceutical ingredients, Generic drugs, Prescription drugs, Submission and registration

Tags: Abbreviated New Drug Application, ANDA, Compounding, Daraprim, Isuprel

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

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

FDA Appoints Members to New, Influential Advisory Committee By Alexander Gaffney, RAC - Published 16 December 2014

Almost a year after announcing the re-creation of its Pharmacy Compounding Advisory Committee (PCAC), the US Food and Drug Administration (FDA) has announced that it has selected 12 experts who will serve on the influential committee as it considers how best to regulate the pharmaceutical compounding sector.

Categories: News, US, CDER, Drugs

Tags: PCAC, Pharmacy Compounding Advisory Committee, Difficult-to-Compound List, AdComm, 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

FDA Guidance Sets up User Fee System for Pharmaceutical Compounders By Alexander Gaffney, RAC - Published 31 March 2014

Categories: US, FDA

Tags: Compounding User Fee, Outsourcing Facility, 503B, User Fee, Latest News, guidance

FDA Hits Two Compounders for Making J&J Drug That Lacked US Approval By Alexander Gaffney, RAC - Published 18 March 2014

Categories: US, FDA

Tags: CPG 460.200, DQSA, Compounding Pharmacy, Compounding, warning letter, Latest News

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