Comments Available on Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act; Request for Nominations

Comment from Kenneth Woliner, MD

• NOMINATION: Compounded Oral Itraconazole (Sporanox) WHY IS THIS DRUG BEING NOMINATED: Gigi Davidson, RPh, explains it better than I can, but simply put, ORAL itraconazole is NOT...

• Public Submission
• Posted:
  02/06/2014
• ID:
  FDA-2013-N-1523-0004

• Agency:
  FDA
• RIN:
  Not Assigned
• Docket ID:
  FDA-2013-N-1523

• Organization:
• Submitter Name:

Comment Period Closed

Mar 04, 2014 11:59 PM ET

Comment from Kenneth Woliner, MD

• NOMINATION: COMPOUNDED HORMONE PELLETS a.k.a. BHRT Fused Pellets Implants (SottoPelle; Armor Vie; other brand names) BACKGROUND: I am a board-certified family medicine physician...

• Public Submission
• Posted:
  02/06/2014
• ID:
  FDA-2013-N-1523-0003

• Agency:
  FDA
• RIN:
  Not Assigned
• Docket ID:
  FDA-2013-N-1523

• Organization:
• Submitter Name:

Comment Period Closed

Mar 04, 2014 11:59 PM ET

Comment from the Arachnoidis Society for Awareness and Prevention

• See Attached

• Public Submission
• Posted:
  03/07/2014
• ID:
  FDA-2013-N-1523-0007

• Agency:
  FDA
• RIN:
  Not Assigned
• Docket ID:
  FDA-2013-N-1523

• Organization:
• Submitter Name:

Comment Period Closed

Mar 04, 2014 11:59 PM ET

Comment from Kenneth Woliner, MD

• NOMINATION: Human Chorionic Gonadotropin (hCG) in any dosage form not injectable (i.e. it is "difficult to compound" hCG in oral, sublingual, intranasal, and topical delivery...

• Public Submission
• Posted:
  02/06/2014
• ID:
  FDA-2013-N-1523-0002

• Agency:
  FDA
• RIN:
  Not Assigned
• Docket ID:
  FDA-2013-N-1523

• Organization:
• Submitter Name:

Comment Period Closed

Mar 04, 2014 11:59 PM ET

Comment from Sarah Sellers, q-Vigilance, LLC

• The attached nomination and comment is respectfully submitted by Sarah Sellers, PharmD MPH, President, q-Vigilance, LLC

• Public Submission
• Posted:
  03/07/2014
• ID:
  FDA-2013-N-1523-0006

• Agency:
  FDA
• RIN:
  Not Assigned
• Docket ID:
  FDA-2013-N-1523

• Organization:
• Submitter Name:

Comment Period Closed

Mar 04, 2014 11:59 PM ET

Comment from Stephen Byrn

• See attached file(s)

• Public Submission
• Posted:
  02/06/2014
• ID: