Search Results for DQSA

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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

New FDA Guidance for First Responders as Track-and-Trace Requirements Take Effect By Zachary Brennan - Published 29 February 2016

Beginning Tuesday, the delayed implementation of product tracing requirements for pharmacies will take effect, and the US Food and Drug Administration (FDA) on Monday issued final guidance saying it will not take action against first responders who fail to obtain tracing information.

Categories: News, US, FDA, Active pharmaceutical ingredients, Compliance, Drugs, Due Diligence, Manufacturing, Postmarket surveillance, Quality

Tags: first responders, track and trace, DQSA, DSCSA, dispensers, pharmacies

FDA Gives Pharmacies Another Four Months to Comply With Track and Trace Requirements Published 30 June 2015

The US Food and Drug Administration (FDA) plans to give drug dispensers—i.e. pharmacies—an additional four months to comply with federal track and trace requirements established under the Drug Supply Chain Security Act (DSCSA).

Categories: News, US, CDER, Biologics and biotechnology, Distribution, Drugs

Tags: Track and Trace, DQSA, DSCSA, Guidance, Draft Guidance

FDA Guidance: Federal Efforts to Secure Supply Chain Trump State Efforts By Alexander Gaffney, RAC - Published 08 October 2014

US regulators have released more information regarding an emerging system intended to prevent counterfeit medicines from reaching US consumers.

Categories: News, US, CDER, Biologics and biotechnology, Distribution, Drugs, Labeling, Packaging

Tags: DQSA, DSCSA, Drug Quality and Security Act, Drug Supply Chain Security Act, Preemption

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

Six New FDA Regulations to be Introduced in 2014, Including Major Change in IND Reporting By Alexander Gaffney, RAC - Published 27 May 2014

The US Food and Drug Administration (FDA) has released an updated list of regulations it is planning to seek in 2014, known as its "Unified Agenda," outlining six new rules it says it intends to propose in 2014.

Categories: News, US, FDA, Distribution, Drugs, Manufacturing, Medical Devices

Tags: US, FDA, Unified Agenda, Proposed Rule, Regulation, Final Rule, 2014 FDA Regulations, DQSA

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

As GSK Recalls Weight Loss Drug After Tampering, A Focus on Limits of the DQSA By Alexander Gaffney, RAC - Published 28 March 2014

Categories: US, FDA

Tags: 503(b)(1), Prescription Drug, Alli, Drug Quality and Security Act, DQSA, OTC, GSK, Track and Trace, Latest News, pharmaceutical, drug

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

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

FDA Cites New Authorities in First Warning Letter to Compounding Pharmacy in Six Months By Alexander Gaffney, RAC - Published 28 January 2014

Categories: US

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

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 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