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

Answer:
This week, we will continue with the extracts from the statement from FDA Commissioner Scott Gottlieb, M.D., and Deputy Commissioner Anna Abram on the new 2019 FDA efforts to improve the quality of compounded drugs. It was released on April 3, 2019. You are encouraged to go to the website provided 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

To secure our public health goals related to compounding, states play a critical role. We partner with them to address the potential risks associated with compounded drugs, while ensuring appropriate access. In 2019, we plan to finalize our memorandum of understanding (MOU) between the FDA and the states. Through the MOU, FDA will further collaborate with the states so that, working together, we can have the greatest public health impact while maximizing our resources. For example, if a compounder distributes drugs to multiple states, it can be difficult to gather information about possible adverse events associated with those drugs, connect them to the compounder and undertake coordinated action to address a potentially serious public health problem without some assistance from the states. These challenges were illustrated by the 2012 nationwide fungal meningitis outbreak. This tragic outbreak led to more than 750 cases of illness and the deaths of 64 individuals. The firm had used a compounded drug for injection that was supposed to be sterile but had become contaminated before distribution to patients and providers. Collaboration with the states has the potential to help prevent such serious and widespread outbreaks by helping to better identify adverse drug events and product quality issues across the country.

The MOU will address traditional compounders that distribute a certain percentage, known as inordinate amounts, of their compounded drugs across state lines. Last September, we issued a revised draft MOU for comment where states would agree to identify compounders that distribute more than 50 percent of their total prescription orders for compounded drugs interstate and report certain information to FDA about those compounders. Under the revised draft MOU, the states will also have greater flexibility on the mechanisms they can use to gather this information. We look forward to finalizing this agreement, taking into consideration stakeholder comments.

Note from Dr. Loyd V. Allen, Jr.: We will continue to 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

News

NOTE:
Some entities are promoting goods and services by stating that pharmacies need to ensure that they are compliant with upcoming USP <800> Requirements. These are NOT Requirements; they are a private organization’s suggested “Standards� that only become “Requirements� when officially adopted by individual state boards of pharmacy. In fact, many states significantly modify them to meet individual state-unique needs prior to establishing their own regulations on compounding with hazardous drugs.

Movement to Reform Pharmacy Benefit Managers Reaches a Boiling Point Nationwide
A wave of reforms to the $400 billion-a-year industry of pharmacy benefit managers (PBMs) is cresting across the U.S. According to the National Academy for State Health Policy, 101 PBM reform bills are being considered in 41 states this year.

PBM’s (such as CVS Caremark, OptumRx, and Express Scripts) contracts typically keep pricing and rebate data secret, leading many to conclude they are partly to blame for the rising price of drugs, which itself is the fastest-rising part of the health-care sector.

As an example, the Ohio Department of Medicaid released its analysis showing that in 2017, CVS Caremark and OptumRx charged taxpayers $224 million more for drugs than they reimbursed pharmacists. That was three to six times the going rate, according to the analyst who did the report, which didn’t look at whether the PBMs were pocketing portions of rebates and other fees they were collecting.
https://www.dispatch.com/news/20190429/movement-to-reform-pharmacy-middlemen-reaches-boiling-point-nationwide

Did You Know ...

…that Thomas Morton stated the following?

“Pride makes us artificial, and humility makes us real.�

Tip of the Week

It seems there are a lot of prideful people today; many individuals think they are the best, but have worked very little to achieve it, and their results are often not significant or even up-to-par. Free-wheeling and thinking one is above others generally leads to a big fall that many cannot handle emotionally! Putting others first, in the long run, builds character and satisfaction.

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Looking Back

Is he lonesome,
Or just blind—
This guy who drives
So close behind?
     Burma-Shave