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Analyses of Defect Reports by Ireland’s IMB and FDA Highlight Packaging and Labeling as Key Pharma Manufacturing Problem Area

Analyses by the Irish Medicines Board (IMB) and FDA of their data on deviation reporting over the past few years indicate the prominence of packaging and labeling as a problem area in the pharmaceutical manufacturing arena....

Pharmacy Compounding Legislation Introduced in Both Houses of Congress Provides for FDA Regulatory Flexibility and Inspection Authority

Legislation has been introduced in both houses of Congress that would provide FDA with the power and flexibility it needs to define the regulatory requirements for high-risk compounding operations and the authority to inspect those that engage in interstate commerce....

Compounder Recalls, 483s and Warning Letters Continue in Wake of FDA Inspection Blitz

The wave of recalls of contaminated preparations and FDA-483s is continuing as FDA’s extensive inspection blitz of compounding pharmacies across the US hits the four-month mark....

The Sterility Risks in Pharmacy Compounding Can Be Limited, Not Eliminated, Experts Stress at USP Forum

The sterility control challenges that pharmacy compounding presents stretch from practitioners trying to handle continually changing procedures and preparations, to the laboratories trying to do quality control testing in the context of these shifting targets and sample constraints, to the array of distribution and storage avenues – and limiting the risks rather than eliminating them should be the goal, participants at a US Pharmacopeia (USP) forum agreed....

FDASIA Title VII Implementation Priorities and Action Plans Taking Shape

FDA has been sorting through the multi-faceted supply chain provisions of Title VII of the FDA Safety and Innovation Act (FDASIA) to identify which should be tackled first and to put action plans in place to implement them....

Search Intensifies for Options to Resource-Draining Redundancies of Multiple Agency Inspections

A road map of previous regulatory inspections and their results is among the ideas being voiced by industry that could help avoid resource-draining inspection redundancy by different agencies and rationalize GMP regulation internationally....

IPQ Monthly Update — March 2013

The March Monthly Update is centered on the complex web of issues around drug shortages and their interconnection with the compliance problems at contract manufacturers and large scale pharmacy compounders, which in effect serve as sterile product contract manufacturers for hospitals....

FDA and EU Inspectors Draw Insight at Contract Manufacturers Into GMP Enforcement/Drug Shortage Crosscurrents

U.S. and European health agency inspectors are gaining more insights during their inspections of contract manufacturers into the complexities of balancing GMP enforcement with drug shortage prevention....

Iowa, Massachusetts, California and Virginia Intensify Compounding Pharmacy Crackdown

The crackdown on pharmacy compounding in the wake of the fungal meningitis crisis continues to intensify as states such as Iowa, Massachusetts, California and Virginia pursue a combination of tougher licensing requirements, more frequent inspections, aggressive enforcement, and a better understanding of the operations of compounders selling in their states....

FDA Investigators Checking Hospira’s Remediation Progress

In a Feb. 13 call with investors following Hospira’s release of fourth quarter financial results, CEO Michael Ball indicated that FDA was currently inspecting the Rocky Mount plant.  He noted that the company has allocated about $375 million for its remediation efforts, including covering tens of thousands of hours for consultants and has been slowly […]
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