Thursday, February 27, 2014

Over One Year After My Inquiry to FDA I received the Following Answer--Thought I would Share So Everyone Would Know the Answer and Understand the Process

Dear Ms. Richmond:

This is in response to your e-mail communication dated January 22, 2013, inquiring why a December 8, 2004, warning letter to Veterinary Enterprises of Tomorrow is not listed on the Pharmacy Compounding web page.  You also asked what other letters are not included on that page and where these letters are located on the FDA web site.

The Pharmacy Compounding web page (http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm339771.htm) includes information related to compounded human drug products.  The Veterinary Enterprises of Tomorrow warning letter concerns compounded veterinary drug products, and, therefore, is not included on the Pharmacy Compounding web page.

Warning letters issued by the Agency between 1996 and the present, including the 2004 letter to Veterinary Enterprises of Tomorrow, are available on the following webpage: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm.

We hope this responds to your inquiry.  Should you have additional questions or require additional information, please contact Compounding@fda.hhs.gov.

Sincerely,

Edisa L. Gozun, PharmD
Compounding and Pharmacy Practices Branch
Division of Prescription Drugs
Office of Unapproved Drugs and Labeling Compliance
OC, CDER, FDA

Final Rule; Zoetis Inc., et al.; Withdrawal of Approval of New Animal Drug Applications for Combination Drug Medicated Feeds Containing an Arsenical Drug2

Tuesday, February 25, 2014

Animal Health Literacy Pet Food and Treats in Your Home

Animal Health Literacy Pet Food and Treats in Your Home

FDA Animal and Veterinary CVM February Notices

2014 Notices

Monday, February 24, 2014

The Law of Compounding Medications And Drugs: Texas Veterinary Medical Associaton Annual confere...

The Law of Compounding Medications And Drugs: Texas Veterinary Medical Associaton Annual confere...: ANNUAL CONFERENCE Saddle up, partner, for the 2014 TVMA Annual Conference February 28 – March 2 • College Station   PRE-REGISTRATION I...

The Law of Compounding Medications And Drugs: California Board of Pharmacy Revokes Precision Pha...

The Law of Compounding Medications And Drugs: California Board of Pharmacy Revokes Precision Pha...: Precision Pharmacy, LSC 99351, Administrative Case AC 3769 Bakersfield, CA Through a disciplinary action of the Board, the licenses ar...

Racing manager, 3 vets exit scandal-hit Godolphin | Dallas-Fort Worth Sports News - Sports Ne...

Racing manager, 3 vets exit scandal-hit Godolphin | Dallas-Fort Worth Sports News - Sports Ne...

The Law of Compounding Medications And Drugs: Pegasus Laboratories voluntarily dismisses federal...

The Law of Compounding Medications And Drugs: Pegasus Laboratories voluntarily dismisses federal...: 01/10/2014 10   ORDER ADMINISTRATIVELY CLOSING CASE: Parties shall file stipulation of dismissal by 2/10/2014. Signed by District Judge Ca...

The Law of Compounding Medications And Drugs: Oklahoma Horse Racing Commission Minutes from Janu...

The Law of Compounding Medications And Drugs: Oklahoma Horse Racing Commission Minutes from Janu...: REPORTS Chairman Leonard made the following reports: • The Commission Executive Director, through responsibility delegated to ...

Thursday, February 20, 2014

Med-Vet International Issues Nationwide Recall of Veterinary 1/2cc U-40 Insulin Syringes Due to Mismarked Syringe Barrels – http://www.fda.gov/Safety/Recalls/ucm386613.htm

The Law of Compounding Medications And Drugs: February 20, 2014 Isabell Werth’s suspension spark...

The Law of Compounding Medications And Drugs: February 20, 2014 Isabell Werth’s suspension spark...: Dressage rider Isabell Werth’s suspension for breaching medication rules is causing a rift between the German equestrian federation (FN) a...

The Law of Compounding Medications And Drugs: State struggles to balance race track safety, trai...

The Law of Compounding Medications And Drugs: State struggles to balance race track safety, trai...: By Matt Grubs Updated: Wednesday, February 19, 2014, 10:33 pm Published: Wednesday, February 19, 2014, 9:50 pm   ALBUQUERQUE (KRQ...

Friday, February 14, 2014

Enforcement Report - Week of February 12, 2014 And Here is Entire Report That May Provide An Easier Format to Read than My Individual Post

Enforcement Report - Week of February 12, 2014

The Law of Compounding Medications And Drugs: All lots numbers within expiry of Cyclosporine Opt...

The Law of Compounding Medications And Drugs: All lots numbers within expiry of Cyclosporine Opt...: Veterinary Cyclosporine Opthalmic (vet use) All lot numbers within expiry. Class III Sterility could not be assured. Natures Pharmac...

The Law of Compounding Medications And Drugs: FDA Enforcement Report Dated February 12, 2014 con...

The Law of Compounding Medications And Drugs: FDA Enforcement Report Dated February 12, 2014 con...: Veterinary AMIKACIN SULFATE*-PF 250MG/ML INJECTABLE Lot t10162013@20 Best By 10/30/2013 Class II Unexpired sterile compounded human ...

Abbott Animal Health is voluntarily recalling the ten lots of OroCAM (meloxicam) Transmucosal Oral Spray for Dogs due to the possibility that some animals could receive an incorrect dose during administration.

Veterinary OroCAM is supplied in three glass vial sizes containing 6 mL, 11 mL and 33 mL of meloxicam. Each vial has a different metered dose pump delivering a dose of 0.25 mg, 0.50 mg, or 1.075 mg, per spray, respectively. Manufactured for Abbott Laboratories; North Chicago, IL 60064 USA; Product of Spain *** US PRODUCTS *** 1) 6 mL Vials. List Number 04943-04-01. Lot Codes and Expiration Dates: EMFG, 11/2014; FBDN, 02/2015; FEBU-3, 05/2015, FEBU-1, 05/2015. 2) 11 mL Vials. List Number 04943-04-02. Lot Codes and Expiration Dates: EMFF, 11/2014; FEBU-2, 05/2015. 3) 13 mL Vials. List Number 04943-04-03. Lot Codes and Expiration Dates: EMFG-1, 11/2014; EMGL, 11/2014; EMGM, 11/2014, EMGN, 11/2014. *** FOREIGN PRODUCTS *** 4) 6 mL Vials. List Number 04943-90-01. Lot Codes and Expiration Dates: EDEG-2, 05-2014; EKFE, 9-2014. 5) 6 mL Vials. List Number 04943-27-01. Lot Codes and Expiration Dates: EDEG, 05-2014. 6) 6 mL Vials. List Number 04943-03-01. Lot Codes and Expiration Dates: 33008XN, 10-2015.; 33004XN, 10-2015. 7) 11 mL vials. List Number 04943-90-02. Lot Codes and Expiration Dates: EDEG-3, 05-2014; EFKE-1, 09-2014. 8) 11 mL Vials. List Number 04943-27-02. Lot Codes and Expiration Dates: EDGE-1, 05-2014. 9) 33 mL Vials. List Number 04943-27-03. Lot Codes and Expiration Dates: EDEH, 05-2014; EDEF, 04-2014; EHGM, 08-2014. 10) 33 mL Vials. List Number 04943-90-03. Lot Codes and Expiration Dates: EFFW, 06-2014; EHEK, 09-2014.

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Class II Abbott Animal Health is voluntarily recalling the ten lots of OroCAM (meloxicam) Transmucosal Oral Spray for Dogs due to the possibility that some animals could receive an incorrect dose during administration. A limited number of units from lots FEBU-2 and FEBU-3 were found to contain incorrect pumps. Abbott Laboratories

The Law of Compounding Medications And Drugs: Thread With Comments from Barrel Racing World Is M...

The Law of Compounding Medications And Drugs: Thread With Comments from Barrel Racing World Is M...: Posted by TrailGirl: 1. The fact that a "Cinnamon-Ginseng"  powder could become incidentally "contaminated" with a syn...

Compounding: Advocating Member Needs

Compounding: Advocating Member Needs

The Law of Compounding Medications And Drugs: Recent 16 year Suspension by New Mexico Racing Com...

The Law of Compounding Medications And Drugs: Recent 16 year Suspension by New Mexico Racing Com...: STINEBAUGH ON THE SIDELINES AS FOUR OF HIS HORSES CHASE WEST TEXAS WIN By PETE HERRERA – April 12, 2013 – It’s the first big futurity of ...

The Law of Compounding Medications And Drugs: by JANE ALLIN Tuesday's Horse Blog provides great ...

The Law of Compounding Medications And Drugs: by JANE ALLIN Tuesday's Horse Blog provides great ...: read her comments here

Thursday, February 13, 2014

More on Weatherford Compounding Pharmacy--Viagra Suspension: A Trail From China to New Mexico | Paulick Report – Thoroughbred Horse Racing News

Viagra Suspension: A Trail From China to New Mexico | Paulick Report – Thoroughbred Horse Racing News

Food Safety Modernization Act (FSMA) FSMA Public Meeting: Proposed Rule on Sanitary Transportation of Human and Animal Food – College Park, MD

Food Safety Modernization Act (FSMA) FSMA Public Meeting: Proposed Rule on Sanitary Transportation of Human and Animal Food – College Park, MD

Viagra Positives Land New Mexico Trainer 16-Year Ban | Paulick Report – Thoroughbred Horse Racing News

Viagra Positives Land New Mexico Trainer 16-Year Ban | Paulick Report – Thoroughbred Horse Racing News

The Law of Compounding Medications And Drugs: Stinebaugh Handed 16 Year Suspension--Weatherford ...

The Law of Compounding Medications And Drugs: Stinebaugh Handed 16 Year Suspension--Weatherford ...: Trainer John Stinebaugh handed a 16 year suspension, expected to appeal. Stallionesearch.com February 12, 2014 Longtime trainer John St...

Friday, February 7, 2014

FDA’s Center for Veterinary Medicine recently released its Fiscal Year (FY) 2013 user fee performance reports to Congress for the Animal Drug User Fee Act (ADUFA), and the Animal Generic Drug User Fee Act (AGDUFA). FDA exceeded all ADUFA and AGDUFA performance goals for FY 2013.
 
 

Wednesday, February 5, 2014

Product Safety Information Veterinary Medication Errors

Product Safety Information Veterinary Medication Errors

Veterinary Medicine Student Programs

Veterinary Medicine Student Programs

Guest Column: SAFE ACT protects horses from slaughter, sale, and consumption


The Law of Compounding Medications And Drugs: WV Court Upholds Penalties for Horse Trainer Grove...

The Law of Compounding Medications And Drugs: WV Court Upholds Penalties for Horse Trainer Grove...: Feb. 4, 2014 A circuit court in West Virginia has upheld the penalties levied against trainer Chris Grove for a Class 1 positive at Hollyw...

Senate passes $100 billion-a-year farm bill, sends to president

Saturday, February 1, 2014

The Law of Compounding Medications And Drugs: Kentucky racing commission panel to look at whethe...

The Law of Compounding Medications And Drugs: Kentucky racing commission panel to look at whethe...: Kentucky racing commission panel to look at whether medication rule places blame in proper place Monday, January 2...

House Passes Farm Bill, Senate Approval Expected


Thursday, January 30, 2014
On January 29, 2013, The House of Representatives passed a multi-year Farm Bill known as the Agricultural Act of 2014. The bill will set national agriculture policy and reauthorize many U.S. Department of Agriculture (USDA) programs for the next five years. The horse industry is not as dependent on programs authorized by the Farm Bill as other segments of American agriculture. However, several programs important to the horse industry are reauthorized by the bill, including livestock disaster programs, the Market Access Program, and the Environmental Quality Incentives Program. ***Courtesy of the American Horse Council
 
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