FDA has opened a Public Docket on Drug Compounding where they are asking for your comments

FDA has opened a Public Docket on Drug Compounding where they are asking for your comments

Do you have ideas, opinions, and thoughts for the FDA about compounding pharmacies? Well if you do, the FDA has opened a Public Docket on Drug Compounding where they are asking for your comments. A FDA notice to industry states that comments by the public DO NOT have to be tied to any specific regulations, guidances, draft guidances, or the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA is specifically seeking your opinions, concerns, and experiences with compounding pharmacies.

Experts agree that the best way to communicate to FDA is to provide a personal narrative of your experiences and thoughts. Your personal comments of how the FDA is impacting compounded drugs, compounding pharmacies, etc., will carry more weight than comments that are auto generated.

All of us at McGuff wish to thank you for your participation to help assure the compounded drugs you need are available when you need them.

Make your comments to the FDA here: https://www.regulations.gov/comment?D=FDA-2015-N-0030-0001 For help on how to navigate and submit your comment to the FDA website please refer to the end of this blog post.

If you are having difficulty on what to comment on, here are a few different topics to spark your creative mind:

  • Why do you need compounded drugs?
  • The FDA, through a memorandum of understanding (MOU), is going to prohibit McGuff Pharmacy from shipping to any patient outside the state of California. Do you have a compounding pharmacy that makes the drugs you need and of comparable quality in your state?
  • What would happen if all compounding pharmacies no longer existed?
  • Would patient care improve with access to office-use compounded drugs (this allows a physician to have the compounded drugs on hand in the office when you need them)?
  • How has the burden of patient specific prescriptions affected you?
  • How has the increase in compounded drug prices within the last 2 years affected you?
  • How has the reduction of compounding pharmacies in the market affected you?
  • Are you concerned about the quality of the compounded drugs you use?

We, at McGuff, understand that time to address your concerns with the FDA may be a lengthy process. Therefore, if you choose to, we have prepared a comment to the FDA from our perspective which can be found here.
Please feel free to edit and change the prepared comment as you see fit.

If you have any questions or concerns please let us know and call us at (877) 444-1133. We are here to help and hope you have a wonderful day!

Help on How to Navigate and Submit Your Comments:

Please visit the following website: https://www.regulations.gov/comment?D=FDA-2015-N-0030-0001

  1. 1) For a good background on how to submit effective comments click on "View Comments Checklist"
  2. Fill in the comment field.
    • If you chose to add our prepared comment upload the file by clicking on the "Choose Files" button
  3. Enter your name, contact information and third party, if desired.
  4. Select a Category that best identifies you.
  5. Review your submission. Check the box at the bottom and click "Submit Comment"
  6. On the Your Preview screen follow directions and check the "I read and understand the comment above" box and click "Submit Comment".

You will now see a receipt for your submission and you are done. Thank you very much for your support!

Paper Submissions:
Mail, Hand Delivery, Courier submissions please send to:

Division of Dockets Management (HF-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

Reference Material:

FDA Notice to Industry:
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Pharm ...