The FDA has released its "2018 Compounding Policy Priorities Plan," which begins as follows (quoting Dr. Scott Gottlieb, FDA Commissioner):

"Pharmacy compounding continues to play an important role in helping patients and providers advance public health."

The 2018 Compounding Policy Priorities Plan specifically details how the FDA will:

• address manufacturing standards for outsourcing (503b) facilities;
• regulate compounding from bulk drug substances;
• restrict compounding of drugs that are essentially copies of FDA-approved drugs;
• solidify the FDA's partnership with state regulatory authorities; and
• provide guidance on other activities that compounders undertake.

The Commissioner goes on to explain that the FDA will be making changes to some proposed policies to better ensure the balance between the need to preserve access for patients with the FDA's obligation to protect patients from poor quality compounded drugs. As an example, he states they are taking steps to make it more feasible for certain compounders to become 503b Outsourcing Facilities by taking a risk-based approach to lower costs, etc.

The FDA also released three guidances last week, as follows:

• Compounded Drug Products that are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act
• Compounded Drug Products that are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act
• Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application

All the above listed topics will be summarized/covered over the next few weeks in this Newsletter.

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

Shelf-life Extension for Baxter Intravenous Solutions
Because of the ongoing critical shortage of IV solutions used in critical care, the FDA is alerting healthcare professionals of the extension of the shelf life involving some of these products. Products listed in the table below may be used beyond the manufacturer's labeled expiration date.

The FDA is not requiring or recommending that the identified products be relabeled with their new use dates. However, if a replacement product becomes available during the extension period, then it is expected that the products listed in this table will be replaced and the products should be properly disposed of as soon as possible.

Healthcare professionals are instructed to squeeze the bags prior to use for verification of no leaks. If leaks are found, the bags are not to be used.
https://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm593084.htm

Imprimis Advertising Receives FDA Warning
The FDA has issued a warning letter to Imprimis Pharmaceuticals Inc. accusing it of making false or misleading claims that its compounded ophthalmics had FDA approval. The FDA's letter was focused on the terminology: "Dropless Therapy," "Less Drops," "Simple Drops," and "Klarity C-Drops." Imprimis compounding pharmacies do not make FDA-approved drugs. The FDA's letter said that Imprimis' website violated the Federal Food, Drug and Cosmetic Act by claiming "Simple Drops" and "Klarity C-Drops" were made with FDA-approved components. The FDA told Imprimis that it should take prompt action to correct the violations and that failure to do so could result in legal action.
https://www.reuters.com/article/imprimis-fda/imprimis-receives-fda-warning-over-eye-medication-advertising-idUSL1N1PB1IU

Did You Know ...

�that at this point it appears that the number of registered 503b outsourcing compounding pharmacies is still holding in the 60s with some ups and downs?

Tip of the Week

The FDA has plans of modifying some aspects of the requirements for 503b compounding pharmacies; it will be important to keep aware and monitor these as they are introduced!

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