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Sterile Compounding Warning Letters Continue

FDA’s warning letter stream to sterile drug product compounding pharmacies continued in April and May with letters to: Blue Ridge Pharmacy and Compounding Center, Grandpa’s Compounding Pharmacy, Brookfield Prescription Center, and Nature’s Pharmacy & Compounding Center. Drug approval and sanitization issues remain top concerns [See IPQ April 14, 2014 for an update on FDA’s crackdown […]

HHS Looks for Transparency in Compounding Drug Reimbursement

In late April, HHS made available its study designed to determine the costs and oversight for compounded drugs under Medicare Part B. Based on the lack of existing information related to Medicare and compounded drugs, the study recommends: ● that the Center for Medicaid and Medicare Services (CMS) establish a method to identify Part B […]

Wave of FDA Warning Letters to Injectable Compounders in Q1 2014 Follows 2013 Inspection Blitz and Legislative Empowerment; Recipients Among Those Applying for Outsourcing Status

A bolus of FDA warning letters to injectable compounding operations in the first quarter of 2014 has followed in the wake of the agency’s 2013 inspection blitz of high-volume sterile pharmacy compounding operations nationwide and legislative empowerment through the Drug Quality and Safety Act (DQSA), signed into law in November....

Comments on FDA’s Draft Compounding Guidances Reflect Complex Factors and Varied Stakeholders Involved

Draft guidances and Federal Register (FR) notices issued by FDA in December to help implement the compounding provisions in the Drug Quality and Safety Act (DQSA) drew a wide array of comments that reflect the complexity of the factors that need to be considered in advancing the regulatory processes for compounding....

Compounding Drivers and Problems Dissected by Merck Pharmacy Expert at April PDA Annual Meeting

Root causes of the problems in the pharmacy compounding arena range from the absence of training in pharmacy schools to commercial pressures that prompt established pharmaceutical firms to leave the market and force hospitals to rely on less qualified providers to fill their immediate patient needs, Merck Engineering BioSterile Validation Director Chris Smalley commented at the April PDA annual meeting held in San Antonio, Texas....

DQSA Title I Cited in Warning Letter to Pharmacy Compounder

A warning letter issued to Triangle Compounding Pharmacy is the first to cite Title 1 compounding provisions of the Drug Quality Security Act (IPQ December 28 2013). The letter, issued in the wake of a Feb./March 2013 inspection states that the sterile drug compounder does not “qualify for the exemptions in section 503A of the […]

CDER Compliance Office Quality Regulatory Priorities for 2014 Include Implementing DQSA, FDASIA and Reorganization Plans

The top priorities at FDA’s Center for Drug Evaluation and Research (CDER) compliance office in 2014 will include implementing the compounding (Title I) and track and trace (Title II) provisions of the Drug Quality and Security Act (DQSA), signed into law in late 2013, along with the ongoing implementation efforts on the generic drug user fee (Title I), supply chain (Title VII) and drug shortage (Title X) facets of the 2012 FDA Safety and Innovation Act (FDASIA)....

IPQ Monthly Update, November/December 2013

In focus is the transformation underway in FDA’s generics program under GDUFA, the agency’s implementation of the compounding provisions of the DQSA legislation, and the regulator/industry effort to tighten the quality/clinical connection….

FDA Moves Quickly to Implement Compounding Provisions of Drug Quality and Security Act

FDA is moving quickly to give regulatory flesh to the compounding provisions of the new Drug Quality and Security Act of 2013 (DQSA), signed into law by President Obama on November 27....

IPQ Monthly Update — May, 2013

The IPQ "Monthly Update" for May is now available. Read this story for a concise summary of its contents.
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