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

Answer:
The following are simply extracts from the statement from FDA Commissioner Scott Gottlieb, M.D., and Deputy Commissioner Anna Abram on new 2019 efforts to improve the quality of compounded drugs. The statement was released on April 3, 2019. You are encouraged to go to the following website and read the statement in its entirety.

Statement

“We’ve long recognized that compounded drugs can serve an important role for patients whose medical needs cannot be met by an FDA-approved drug product. But compounded drugs are not approved by the FDA and, therefore, have not been evaluated for safety or efficacy. We’ve seen firsthand the harm they can cause patients when they’re not appropriately compounded.

Over the past year, we’ve taken significant new steps to modernize and clarify our policies related to the quality of compounding in an effort to ensure continued access to compounded drugs for patients who need them, while also protecting patients from the risks of contaminated or otherwise harmful products. We’ve worked to refine our existing practices, shape new policies and increase the frequency of our communications with industry, Congress, states and patients concerning our programs. We anticipate that 2019 will be an equally productive year for the FDA’s compounding program, with better quality continuing to be our top priority as part of our ongoing effort to reduce the risks of these unapproved products. We have an obligation to advance our efforts to improve the quality of compounded products for consumers by ensuring we have a strong and modern regulatory framework in place.

Toward these goals, we’re pleased to share our 2019 compounding priorities. The FDA will continue to work with stakeholders to improve the quality of compounded drugs for patients who need these products.�

The following are sections in the Statement that will be presented in this Newsletter over the next few weeks:

• 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
  
  

Note: We will provide the text for each of the sections over the next few weeks; meanwhile, the complete statement can be obtained at:

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

Announcement

"SPEAKER CALL: The International Academy of Compounding Pharmacists (IACP) is looking for knowledgeable, energetic, and experienced speakers who want to share their expertise with others. Audiences include 300+ practicing primary and specialty care providers who will be participating in a 10-minute question and answer session at the end of your presentation. IACP would like to offer speakers an opportunity to present for IACP at our annual conferences; Educational Conference or Compounders on Capitol Hill. In addition to our IACP AdvanCE live webinars. Follow the link to register https://www.iacprx.org/page/IACPSpeakerVolunteer or email IACPinfo@iacprx.org to nominate someone you know."

News

FTC Calls “no-Authorized Generic Commitment� a “Pay-For-Delay� Agreement
The Federal Trade Commission (FTC) found that an agreement not to market an authorized generic—called a “no-AG commitment�—can be considered a form of reverse payment to delay the entry of generic competition. The original complaint involved Endo Pharmaceuticals, which sought to block the market entry of generic versions of two of its products, Opana ER and Lidoderm, which together made up about 64% of Endo’s total annual revenues. In June 2010, the FTC charged that Endo agreed to pay Impax more than $112 million to abandon its patent challenge and forgo entering the market with its lower-cost generic version of Opana ER for 2½ years, until January 2013. But with that payment, Endo also agreed that it would not bring an authorized generic version of Opana ER to market, meaning Impax would be the only seller of generic Opana ER during its first 180 days on the market.
https://www.raps.org/news-and-articles/news-articles/2019/4/ftc-calls-no-ag-commitment-a-pay-for-delay-agreeme

Three States Join Contested Missouri Ban on Using the Term “Meat� on Cell-Cultured and Insect Product Labels
While lawyers continue talking in Missouri, lawmakers in at least three more states have passed bills to legally prohibit “mislabeling� of food products derived from animal cultures, plants, or insects as meat. Other bills limiting what can be labeled as meat are under consideration in Arizona, Arkansas, Colorado, Illinois, Indiana, Nebraska, North Dakota, Virginia, Washington, and Wyoming. Missouri was the first state to prohibit plant and lab-grown alternatives from labeling those products as meat. The cell-cultured industry immediately took Missouri to court in a case known as Turtle Island Foods v. Missouri.
https://www.foodsafetynews.com/2019/04/3-states-join-contested-missouri-ban-on-using-meat-on-cell-cultured-product-labels/

FDA Warns Homeopathic Firms for Manufacturing Quality Violations
The U.S. FDA posted warning letters to four companies that produce homeopathic drug products for significant violations of CGMP regulations. The warning letter to King Bio Inc. provides details of flaws in manufacturing operations and quality-assurance systems found during a July 2018 FDA inspection of the facility. Also were actions involving Red Mountain Incorporated, Oakland Park, Florida (snake venom); Tec Laboratories Incorporated, Albany, Oregon; and B. Jain Pharmaceutical Pvt. Ltd., Rajasthan India (insects).
https://www.americanpharmaceuticalreview.com/1315-News/359779-FDA-Warns-Homeopathic-Firms-for-Putting-Patients-at-Risk-with-Manufacturing-Quality-Violations/

Did You Know ...

…that Claudius Galenus (AD 130-AD201), a Greek physician made the following statement?

“That physician will hardly be thought very careful of the health of others who neglects his own.�

Tip of the Week

Other than “before and after photos,� have you ever wondered why overweight/obese actors/actresses don’t advertise exercise equipment, or poor nutrition actors/actresses advertise food products? Also, we don’t see patients with cancer advertising cigarettes, chewing tobacco, snuff, etc. Maybe it’s because we wouldn’t look very positive on the product they are advertising.

How about physicians, nurses, pharmacists, etc.? Should we be reasonably health conscience and take care of ourselves to present to patients “health professionals that take care of themselves?� Probably so…

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Looking Back

When you lay,
Those few cents down,
You’ve bought the smoothest
Shave in town!
     Burma-Shave