Druggmpreport

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February 2018

No. 307

Headlines

Full Issue of Drug GMP Report in PDF Format

Download and view the full issue. Read More

FDA to Define GMPs for Outsourcing Facilities

The FDA issued a compounding policy priorities plan for 2018, highlighting manufacturing standards for outsourcing facilities and collaboration with state regulators. Read More

Quality System Deficiencies Dominate MHRA’s GDP Deficiency Report

Problems with quality topped the list of major good distribution practice deficiencies in 2016, according to the latest update from the UK’s Medicines and Healthcare products Regulatory Agency. Read More

FDA Clarifies Conditions for Mixing, Diluting or Repackaging Biologics

The FDA issued a final guidance on approved biologics that are mixed, diluted or repackaged, noting when the agency will not take action against violations of its standard rules on product misbranding and false and misleading labeling. Read More

FDA Drops Biennial Inspection Requirement for Biologics

The FDA issued a direct final rule removing the biennial inspection requirement for biologics production facilities and adopting a more flexible, risk-based approach to how often the agency will conduct inspections. Read More

Warning Letter Roundup: Five Firms Warned for Misbranding, GMPs

The FDA cited issued warnings letter to drugmakers in Japan, Mexico, Australia and to three in the United States for GMP and other deficiencies. Read More

483 Roundup: Six Firms Flagged for Variety of Violations

The FDA issued Form 483 reports to facilities in Germany, China, Mexico, South Korea, the United Kingdom and the U.S. for a range of nonconformance issues. Read More

OPDP Enforcement Letters in 2017 Hit Record Low

The FDA’s Office of Prescription Drug Promotion issued just three warning letters and one untitled letter in calendar year 2017 — a record low and down from a high of 156 in 1998. Read More

FDA Proposes Packaging Reductions to Curb Opioid Addiction

The FDA proposed a new tactic in its fight against the opioid epidemic — blister packs of smaller quantities of opioid drugs that could give providers better prescription options, especially for drugs like Vicodin and Percocet usually intended for short-term use. Read More

Gottlieb Outlines FDA Plans for Compounding Enforcement

In Jan. 30 testimony before a House subcommittee, FDA Commissioner Scott Gottlieb told lawmakers the FDA’s plans for regulating compounding pharmacies, including adapting GMP and oversight standards to a facility’s level of risk. Read More