Friday, June 21, 2024

 

FDA allows compounded FIP drug in certain cases

May 23, 2024 — The Food and Drug Administration recently announced that it does not intend to enforce new animal drug approval requirements for the antiviral medication ...

 

Drugmakers, compounders at odds over FDA's difficult-to- ...

13 hours ago — Drugmakers laud the US Food and Drug Administration's (FDA) proposed rule on drugs that are difficult to compound by pharmacies and outsourcing facilities.

 

APC: News

Jun 6, 2024 — “We have serious concerns about the Board's proposed regulations and the ongoing failure of the Board to root its regulation and enforcement of compounding in ..

 

Cal. Code Regs. tit. 16 § 1735

Jun 7, 2024 — Section 1735 - Compounding in Licensed Pharmacies (a) "Compounding" means ... Preparing a compounded drug preparation from chemicals or bulk drug substances (b) "

 

FDA alerts health care professionals, compounders and ...

Jun 5, 2024 — FDA has received reports of allergic-type reactions potentially related to sulfite-containing compounded drugs. FDA is alerting health care professionals, ...

 

 

  • On Tuesday, the FDA approved phenylpropanolamine hydrochloride chewable tablets for the control of urinary incontinence due to a weakening of the muscles that control urination (urethral sphincter hypotonus) in dogs. This is the first generic phenylpropanolamine hydrochloride chewable tablets for dogs. Phenylpropanolamine Hydrochloride chewable tablets contain the same active ingredient (phenylpropanolamine hydrochloride) in the same concentration and dosage form as the approved brand name drug product, Proin chewable tablets, which were first approved on Aug. 4, 2011.

 On Tuesday, the FDA posted warning letters to four companies marketing the unapproved animal drug toltrazuril to treat conditions like coccidiosis and equine protozoal myeloencephalitis (EPM). The companies included All Things Bunnies Inc.Linessa Farms LLCTotalTotrazuril.com and Toltrazuril Shop