Updated April 2, 2014 Compounding Compounding: Inspections, Recalls, and other Actions

Compounding Compounding: Inspections, Recalls, and other Actions

FDA Drug Enforcement Report April 2, 2014

Drugs	DermOtic Oil (fluocinolone acetonide) 0.01% Ear Drops, 20 mL bottle, Rx only Manufactured and Distributed by: Hill Dermaceuticals, Inc. Sanford, Florida 32773 NDC 28105-160-20	12H028B exp. 01/14	Class III	Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.	Hill Dermaceuticals, Inc.
Drugs	Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Scalp Oil), 4 fl. oz., Rx only. Manufactured and Distributed by: Hill Dermaceuticals, Inc. Sanford, Florida 32773 NDC 28105-149-04	12J030C exp. 03/14, 12L041C exp. 05/14	Class III	Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.	Hill Dermaceuticals, Inc.
Drugs	Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Body Oil) 4 fl. oz., Rx only Manufactured and Distributed by: Hill Dermaceuticals, Inc. Sanford, Florida 32773 NDC 28105-150-04	13D010A exp. 10/14.	Class III	Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.	Hill Dermaceuticals, Inc.
Drugs	ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Body Oil) 4 fl. oz., Rx only Manufactured by: Hill Dermaceuticals, Inc. for: Royal Pharmaceuticals NDC 68791-101-04	13E013A exp. 11/14.	Class III	Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.	Hill Dermaceuticals, Inc.
Drugs	ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% (Scalp Oil), 4 fl.oz., Rx only Manufactured by: Hill Dermaceuticals for: Royal Pharmaceuticals NDC 68791-102-04	13E014A exp. 11/14, 13F02C exp 12/14.	Class III	Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.	Hill Dermaceuticals, Inc.
Drugs	ROYAL PHARMACEUTICALS DermOtic Oil fluocinolone acetonide 0.01% (Ear Drops), 20 ml, Rx only Manufactured by: Hill Dermaceuticalsfor: Royal Pharmaceuticals NDC 68791-103-20	13F015B exp. 12/14, 13G023B exp. 01/15	Class III	Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.	Hill Dermaceuticals, Inc.
Drugs	SETON PHARMACEUTICALS Fluocinolone acetonide 0.01% Topical Oil (Scalp Oil), 4 fl.oz., Rx only Manufactured by: Hill Dermaceuticals, Inc. For: Seton Pharmaceuticals NDC 13925-507-04	13F015C exp. 12/14.	Class III	Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.	Hill Dermaceuticals, Inc.
Drugs	SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Topical Oil (Body Oil), 4 fl.oz., Rx only Manufactured by: Hill Dermaceuticals, Inc. For: Seton Pharmaceuticals NDC 13925-506-04	13F016A exp. 12/14.	Class III	Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.	Hill Dermaceuticals, Inc.
Drugs	SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Oil EAR DROPS, 20 ml, Rx only Manufactured by: Hill Dermaceuticals, Inc. For: Seton Pharmaceuticals NDC 13925-508-20	13F017B exp. 12/14, 13F020B exp 12/14	Class III	Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.	Hill Dermaceuticals, Inc

Warning Letters Libi Labs, Inc. 3/13/14

Warning Letters Libi Labs, Inc. 3/13/14

AFL Implements Its Own List Of Banned Substances for horse racing

In a case of closing the gate after the horse has bolted, the AFL has revealed its own list of banned substances, which includes processes and substances that are not on the World Anti-Doping Agency banned list. The list is a part of the wider-ranging anti-doping code the AFL implemented in an attempt to beef up the standards and practices of testing in order to better avoid calamitous situations such as the still-ongoing Essendon situation that totally dominated the past season, and still threatens to cast a shadow over the current one.

With the chief problem in the ASADA investigations across the past 14 months seemingly being a lack of clarification on just about every key substance and process involved, the new list provides comprehensive and clear assertion that substances, including the much mysterious AOD-9604, is now “officially” banned, as far as the AFL is concerned. Though they have not conducted independent scientific analysis into the benefits or risk associated with the drug, the League has, instead, chosen to apply common sense and outlawed it based on the fact that keeping iffy things out of the game is probably for the best on a long-term basis.

Other peptides included on the AFL’s list include a bunch of stuff with acronyms I don’t recognise, but am going to have a lot of fun making up meanings for right now, such as GHRP-2 (Get Huge, Rot Pancreas), CJC 1295 (Columbian Jungle Crystals) as well as Intravenous Vitamin C, Intravenous Antioxidants, and something called TA65 (That Ass).

Players or officials found to have transgressed the unwritten rule new set of guidelines will be thrown at the mercy of the AFL’s fearsome judicial system, which includes the game’s highest authority, the AFL commission.

This new set of guidelines does have the potential to stop enormous errors like the Essendon saga from happening, or at the very least discourages it. But above all else it sure as hell safeguards the AFL and its executives from any excessive embarrassment or career jeopardy should it happen again. Because after all, saving face is the most important thing, right?

 

via Herald Sun.

 

ASPCA Animal Drug Approvals April 2014 Update (Green Book)

Although it’s Triple Crown season, the horse racing industry has little to celebrate. A grim cloud of animal cruelty and cheating continues to hang over the sport.

continue to read here

Supplement and Pharma Litigation : Super Fat Burner, Maxi Gold, and Esmeralda Dietary...

Supplement and Pharma Litigation : Super Fat Burner, Maxi Gold, and Esmeralda Dietary...: New Life Nutritional Center is recalling all lots of “Super Fat Burner capsules, Maxi Gold capsules and Esmeralda softgels” to the user le...

FDA Animal Drug Approvals for April 2014

Animal Drug Approvals April 2014 Update (Green Book) – http://www.fda.gov/downloads/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/UCM391441.pdf

FDA Gleans Compounding Funding Bump With Efficiencies, Research Cuts

FDA was able to add $25 million to its budget for compounding oversight by increasing administrative efficiencies and trimming research and outreach activities, the agency said.
InsideHealthPolicy.com

FDA Defends Push For Use Of FDA-Registered Outsource Compounders

 

FDA rebuffed the drug compounding industry's concerns that the agency was premature in reaching out to governors, health departments, boards of pharmacy and hospital purchasers to encourage them to use outsourcing facilities registered with the agency.
subscription required to read at InsideHealthPolicy.com
 

Throw out horse doping charges, accused Penn National trainer asks U.S. judge

By Matt Miller | mmiller@pennlive.com The Patriot-News
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on April 01, 2014 at 11:21 AM, updated April 01, 2014 at 1:03 PM

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 Saying the evidence just isn't there, a midstate horse trainer is asking a U.S. judge to dismiss criminal charges that he doped race horses at Penn National Race Course.

In a motion filed this week, Terrance McGowan, attorney for trainer Samuel Webb of Jonestown, contends that a federal indictment against his client should be tossed, because prosecutors don't have proof of the supposed wrongdoing.
Also, McGowan claims the U.S. Attorney's Office lacks jurisdiction to prosecute Webb, because the offenses with which his client is charged fall solely under the authority of the Pennsylvania Racing Commission, which oversees horse racing in the state.
Webb, two other trainers and a race course worker were charged in the doping case in November.
Webb, fellow trainers David Wells of Grantville and Patricia Rogers of Hummelstown and track employee Danny Robertson of Hershey all have pleaded not guilty to the charges lodged in U.S. Middle District Court.
Webb is the first defendant to take the offensive and ask the court to dismiss his indictment.
In the dismissal motion, McGowan claims prosecutors have not honored his repeated requests to provide a detailed chemical analysis of the substances Webb is accused of using to enhance the performance of his horses. He has not been given information regarding where investigators supposedly found those substances at the East Hanover Township track in Dauphin County, either, McGowan contends.
Also, McGowan argues that government investigators haven't provided specific evidence to back their claims that Webb committed an offense that involved manipulation of Penn National's pari-mutuel wagering system, as is alleged in the indictment.
U.S. Attorney William A. Behe doesn't concur with the dismissal request, McGowan notes in his plea to Senior Judge William W. Caldwell
quoted from here