August 19, 2019

August 19, 2019

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FDA 2018 Year in Review: Good Manufacturing Practice

Developments in 2018

European Mutual Recognition Agreement

In 2017 FDA and the European Union entered into a Mutual Recognition Agreement to use one another’s GMP inspection results for pharmaceutical manufacturing facilities. The initiative became effective November 2, 2017. FDA is currently in the process of evaluating each of the 28 EU countries’ drug inspectorates to determine whether they are capable of meeting FDA’s requirements. As of the date of publication, the following 20 countries’ regulatory authorities have been deemed capable: Austria, Belgium, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Malta, Portugal, Romania, Spain, Sweden and the United Kingdom. The Mutual Reliance Initiative will enable FDA to avoid duplication, reduce costs and focus its resources in other parts of the world where there is greater public health and safety risk.

GMP for 503B Outsourcing Facilities

In December, FDA issued the Current Good Manufacturing Practice – Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act draft guidance, which describes the agency’s policies regarding cGMP for facilities that compound human drugs and register as outsourcing facilities under section 503B of the FDCA (503B facilities). FDA intends to promulgate specific cGMP regulations for 503B facilities. The draft guidance is intended to outline the conditions under which FDA does not intend to take enforcement action against 503B facilities until the agency issues the 503B-specific cGMP regulations. The draft guidance replaces the July 2014 Current Good Manufacturing Practice – Interim Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act draft guidance. It includes considerations for non-sterile compounded drug products and differentiates between requirements applicable to sterile and non-sterile compounded drug products where appropriate. The draft guidance also includes changes relating to stability testing (adding a “beyond-use date” as an expiration date) and release testing requirements. Finally, the draft guidance addresses reserve samples and provides guidance on “in-use times.”     

Read more on FDA 2018 Year in Review.

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Vernessa Pollard Pharmaceutical Attorney McDermott

    Vernessa T. Pollard is a partner in the law firm of McDermott Will & Emery LLP and is based in the Washington, D.C., office. Vernessa serves as co-head of the Firm’s Food and Drug Administration (FDA) practice.

    Vernessa advises companies on regulatory, compliance, enforcement and legislative matters involving pharmaceuticals, medical devices, digital and mobile health, health IT solutions and services, and emerging technologies and software. She also advises national and international food and cosmetic producers and retailers on...

    Veleka Peeples-Dyer, McDermott Will Emery, life sciences industry, FDA attorney, drug safety lawyer, health care fraud counsel,

    Veleka Peeples-Dyer is a partner in the law firm of McDermott Will & Emery LLP and is based in the Firm's Washington, D.C., office. She is an experienced attorney with an extensive background in the Life Sciences Industry, including Food and Drug Administration (FDA) regulation, clinical trials, manufacturing and supply, drug safety, licensing, product acquisition due diligence, health care fraud and abuse and compliance matters. Additionally, Veleka’s experience includes conducting internal investigations, developing and implementing legal and compliance training programs and advising on federal and state transparency, lobbyist and disclosure issues, including the Federal Physician Payments (Sunshine) Act.

    Veleka previously worked as in-house counsel to publicly-traded biotechnology and pharmaceutical companies. She served as a strategic business and legal advisor, counseling on the full range of research, development, regulatory, compliance and commercialization issues that biotechnology and pharmaceutical companies face. Veleka’s earlier corporate counsel experience includes working in the government contracts and utilities industries. Veleka understands the challenges clients face in this industry by providing strategic and practical counsel on the challenges and business complexities that life sciences companies face.

    T Reed Stephens Attorney McDermott Will

    T. Reed Stephens is a partner in the law firm of McDermott Will & Emery LLP and is based in the Firm's Washington, D.C., office.  Reed represents clients involved in the Life Sciences industry, including pharmaceutical and biotech manufacturers, wholesalers, and individuals, as well as health care systems and non-health care related companies in the financial services industry.  In addition to representing clients in matters involving state and federal government law enforcement, voluntary disclosures, and congressional investigations Reed advises clients on mergers...

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    Michael Ryan Attorney specializing in Pharma law McDermott Law Firm

    Michael W. Ryan is a partner in the law firm of McDermott Will & Emery LLP and is based in the Firm’s Washington, D.C. office.

    Michael focuses his practice on the legal, regulatory and reimbursement issues that manufacturers and investors encounter in the development and commercialization of pharmaceuticals, medical devices, biotechnology products and laboratory services.  Michael counsels entities as they seek to obtain authorization to market their products from the U.S. Food and Drug Administration, maintain compliance with applicable laws and regulations (including the...

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    Anisa Mohanty, McDermott Law Firm, Health Care Attorney

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