Question: What are the FDA priorities for compounding for 2019?

Answer:
This is the final installment of the sections from the statement from FDA Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Anna Abram on the 2019 efforts to improve the quality of compounded drugs. You are encouraged to go to the website listed below and read the statement in its entirety.

Statement from FDA Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Anna Abram on new 2019 efforts to improve the quality of compounded drugs

Statement (Opening)

Maintaining Quality Manufacturing and Compliance

Regulating Compounding from Bulk Drug Substances

Finalizing our Memorandum of Understanding with the States

Compounding by Hospital and Health Systems

Additional Compounding Priorities

“Finally, we’ll continue to work closely with stakeholders on a number of other efforts that promote improving the quality of compounded drugs for patients who need them. Among our efforts, we’ll hold a public meeting in May 2019 to discuss current good manufacturing practice (CGMP) for outsourcing facilities and gain public feedback to gauge the potential impact of proposed policies related to CGMP requirements on office stock access for healthcare providers. We’ll also hold additional listening sessions with stakeholders to better understand their views on key issues such as the substances included on the bulks lists and manufacturing requirements for outsourcing facilities as we develop policies that ensure appropriate access while protecting public health.

We look forward to continuing to advance a robust compounding policy framework in 2019 as part of our commitment to fulfilling our vital consumer protection role.

We recognize that there continues to be great interest in our work in this important program. We’re committed to providing detailed updates as we pursue additional actions on behalf of the American public.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.�

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements
/ucm635182.htm

Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition

News

The FDA “Lacks Jurisdiction� Over Death-penalty Drugs
A new legal opinion states that the FDA does not have authority over drugs used in lethal injections. The department’s Office of Legal Counsel said that “articles intended for use in capital punishment by a state or the federal government cannot be regulated as “drugs� or “devices.�

In 2015, the FDA blocked Texas from importing shipments of an anesthetic from an overseas distributor, finalizing the decision two years later. The agency argued the importation was illegal because the drug, sodium thiopental, was not approved in the United States and was improperly labeled. It also cited a 2012 federal injunction barring the agency from allowing the drug’s importation.

Texas responded to the FDA’s move by suing the agency in early 2017, claiming the agency was interfering with the state’s responsibility to carry out its law enforcement duties. The legal opinion from the Justice Department sides against the FDA and with Texas. It says that drugs intended for executions are different from any others, noting that “they exclusively inflict harm� and “are not intended to produce any benefit for the end user.�
https://www.washingtonpost.com/national/health-science/justice-department-says-fda-lacks-jurisdiction-over-death-penalty-drugs/2019/05/14/da056e6c-764d-11e9-b7ae-390de4259661_story.html

Homeopathic Manufacturers Warned by the FDA for Significant Violations of cGMPs
The FDA has sent warning letters to five companies producing products labeled as homeopathic for significant violations of current good manufacturing practice (CGMP) regulations. Four of the warning letters pertain to companies who jointly produced a product labeled as homeopathic that posed a significant safety risk to consumers because their purportedly sterile products were not shown to be sterile. An additional letter outlines a company’s failure to have systems in place to assure proper design, monitoring, and control of manufacturing processes.
https://www.fda.gov/news-events/press-announcements/fda-warns-manufacturers-products-labeled-homeopathic-putting-consumers-risk-significant-violations

Addressing Intravenous Shortages, B. Braun to Double U.S. Production
B. Braun Medical Inc. is investing $1 billion to expand its U.S. production of IV products. The German-based firm will build a facility in Daytona Beach, Florida, and modernize existing plants in California and Pennsylvania. The investment will allow B. Braun to double its production of saline bags, which are used to more easily administer medications, and the accompanying accessories. The investments will give B. Braun manufacturing capabilities on both the East and West Coasts. Ultimately, their plan is to have a duplication of both products lines on both sides of the U.S. at the same time.
https://www.foxbusiness.com/healthcare/iv-shortage-b-braun-invests-1b

Did You Know ...

…that Winston Churchill made the following statement?

“A nation that forgets its past, has no future.�

Tip of the Week

It seems our nation is forgetting what attributes and characteristics have combined to make the U.S. a great nation. The hard-working, unselfish acts of many seem to have been forgotten by some, especially those who evidently feel the government owes them everything (food, shelter, education, medical care, cell phones, etc.)! Fortunately, there are still many who are willing to work hard and sacrifice when necessary…to those who do so, we owe our gratitude and thanks!

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