Here’s What You Missed on Last Month's Call:

Legislative Goals for 2020:

Access, access, ACCESS – Our compounders and pharmacists need access to compounds in order to work effectively, especially the 503A and 503B bulk listed substances.

Fixing the monographs: Regain access to all the substances that were deemed as a “dietary supplement” and therefore required a full dietary supplement monograph.  We are working together to remedy the strange interpretation from FDA via legislation.

Magnify Compounding in Ending Drug Shortage: Senator Collins currently has a bill that would enable compounders to help minimize the effects of the drug shortage. We will continue to support this bill and others that enable compounders to effectively care for patients.

New Regulations for Vet Compounding:

With new “Deeming Rules” and Guidance Document 256 set in place by the FDA, veterinarians and pharmacists would face new regulations in compounding. Although the FDA has no underlying jurisdiction or authority to regulate veterinary medical practices, these new rules would affect the industry by:

Requiring documentation in writing noting the clinical need and medication rational for each patient (animal) when compounding.

Severely restricting the abilities of veterinarians to maintain office stock of compounded medications for their patients. The FDA prefers finished products instead of bulk ingredients, which are more expensive and less effective for specialty compounds.

Biologics Deadline Coming March 2020:

We have discussed this topic previously, but all compounding should be aware of upcoming transitions in the law regarding biologics. Here are some of the basic things you need to know:

When the Affordable Care Act (Obama Care) was passed 10 years ago, it outlined certain regulatory control that would shift from one government act to another. This included the drug substances used in biologic compounding, and would mean that the substances currently listed as 505(1) approved drugs in the current regulations, will become 531PHS approved drugs in the new regulations.

Although the legislation transfers the approved drugs, it does NOT transfer the 503A and 503B exemptions that allow us to use these substances in compounding. These exemptions allow compounders to bypass the traditional Biologics License Application, but if the new regulation does not uphold the exemptions, any biologics compounded after March 23 of 2020 will be deemed as an unapproved drug and in violation of the FDA.

We are working to remedy this issue of transferring the exemptions of 503A and 503B compounding and are hoping for a sympathetic ear in the FDA when it comes to fixing this error and restore biologics in compounding.

What to Expect on this Month's Call:

• Updates on Biologics
• MOU Regulations and “Deeming Rules” that might affect you
• Drug Shortage and Senator Collins next steps

Join the Fight Spotlight:

This section looks to flash a spotlight on those who have joined the fight to advocate for compounding in their local or national legislation.

COMING SOON.

Other Notable Information:

New FDA Commissioner (from FDA.gov)

Dr. Stephen M. Hahn was sworn in as the 24th Commissioner of Food and Drugs on December 17, 2019. Dr. Hahn is a physician, scientist and health care leader with an extensive background in patient care, academic research and executive leadership.

About MEDISCA

Medisca is a global corporation with locations throughout North America, Australia, and Europe, that contributes to healthcare by leveraging strong partnerships that deliver customized solutions with an unwavering commitment to quality and innovation. Backed by 30+ years and a strong foundation in pharmaceutical compounding supply, Medisca is a business-to-business company that delivers comprehensive offerings by providing value, consistency, responsiveness, and loyalty. As Partners in Wellness, Medisca offers an unfailing devotion to improving lives across a multitude of needs and people. For more information visit www.medisca.com and follow us on LinkedIn, Facebook, Twitter, and YouTube.

Contact:

Adam Pinsky