Health Reform + Related Health Policy News - October 17, 2012


In This Issue:

- Top News…1

- State News…5

- Regulatory News…8

- Additional Reading…8

- Federal Register…9

- For More Information…12

- Excerpt From Top News:

Congress, FDA Weigh Regulatory Changes to Compounding in Wake of Meningitis Outbreak

In response to the fungal meningitis outbreak linked to a New England pharmacy, Congress and the FDA are considering changes to the existing regulatory structure to reflect modern pharmacy practices. Twenty three deaths have been linked to a compounded batch of preservative free methylprednisolone acetate, a steroid injection. The FDA previously warned the pharmacy that provided the drug that its practices could be viewed as drug manufacturing and not compounding. The pharmacy, the New England Compounding Center, has since closed and recalled its products.

Pharmacies, including those that compound drugs, are generally regulated by the states. However, rather than compound one prescription at a time for individual patients, some pharmacies reportedly produced some products in bulk to have them ready for orders from hospitals and clinics, which could be considered manufacturing and subject to FDA oversight. In response to the growth in compounding and the regulatory uncertainty, the FDA is pushing for changes to what it described as a “patchwork” of existing regulations. FDA Deputy Commissioner Deb Autor said, “The world has changed a lot since the days of mortar and pestle, and this is the time for pharmacists, for lawmakers, for regulators and for doctors to sit down to grapple with this new model of pharmacy compounding and come up with a regulatory scheme that appropriately controls the risk.” Autor said that the regulations need to be clarified so it can be determined if a pharmacy has moved beyond compounding and into small scale drug manufacturing. She said there is a “legal dispute” over the FDA’s authority to examine pharmacy records. “It is the records that help us to determine whether a pharmacy is acting as a pharmacy or manufacturer,” she said.

Please see full Newsletter below for more information.

LOADING PDF: If there are any problems, click here to download the file.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Polsinelli | Attorney Advertising

Written by:


Polsinelli on:

Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
- hide
- hide

This website uses cookies to improve user experience, track anonymous site usage, store authorization tokens and permit sharing on social media networks. By continuing to browse this website you accept the use of cookies. Click here to read more about how we use cookies.