FDA Issues another 483 on Contract Testing Lab: Boston Analytical, Inc., Salem, NH

ARL Biopharma, Inc. dba Analytical Research Laboratories, Oklahoma City, OK

• 483 Issued 11/8/2012 (PDF - 382KB)

Boston Analytical, Inc., Salem, NH

• 483 Issued 11/9/2012 (PDF - 490KB)
   

Dyna Labs, LLC, St. Louis, MO

• 483 Issued 11/13/2012 (PDF - 1MB)

Eagle Analytical Services, Houston, TX

• 483 Issued 6/17/2013 (PDF - 984KB)
   

Front Range Laboratories, Inc., Loveland, CO

• CDER Statement: FDA Alerts Pharmacies to Concerns with Testing Conducted by Front Range Laboratories (8/21/2013)
• FDA Letter to Front Range Customers (PDF – 65KB)”
• 483 Issued 8/30/2013 (PDF - 1.6MB)

What happens to the FDA in a government shutdown? September 30, 2013 | By Damian Garde Read more: What happens to the FDA in a government shutdown? -

With hope for congressional compromise waning by the hour, the federal government is bracing for its first shutdown in 17 years, and for the FDA, that means furloughing about half its staff and ditching duties it can no longer afford. What that spells for drug developers with eyes on approval, however, remains murky.

If the government shuts down come Tuesday, the FDA will lose 6,620 employees, about 45% of its staff, and the agency would have to cease many inspections, enforcement actions and monitoring operations, also suspending the "majority" of its internal lab research, according to a Department of Health and Human Services briefing.

As for advisory panels, PDUFA dates and the agency services that affect the drug development world, things are more opaque. While the government is quite clear that only mission-critical, life-and-death work will continue, DHHS also said that the "FDA would continue limited activities related to its user-fee funded programs," which would include drug approvals.

Read more: What happens to the FDA in a government shutdown? - FierceBiotech http://www.fiercebiotech.com/story/what-happens-fda-government-shutdown/2013-09-30#ixzz2gRSKPWls
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Stakeholders Urge Swift Senate Action On Drug Compounding, Tracing Bill

Stakeholders, including a bipartisan group of Senate health committee lawmakers, are urging swift Senate action on bipartisan drug compounding/trace and track legislation that passed the lower chamber by voice vote over the weekend.

from Insidehealthpolicy.com

Challenge: September 30, 2013 A challenge to animal owners--Ask as many questions as possible about compounded preparations

I challenge all animal owners to be proactive in the future and ask their veterinary some essential questions when having their animals treated.  If medications are prescribed, asked if they are compounded preparations.   Ask why a compounded preparation is being used?  Is there a commerically available?  Ask why it is not being used?   If compounded preparations must be used ask questions about where the medication is compounded.  Ask who does the compounding.  Ask what qualifies the pharmacy and pharmacists to do the compounding.  And then be more specific and ask what qualifies the pharmacy or pharmacists to compound animal medications.  What special training did the pharmacist receive?  Very few pharmacists have the specific knowledge and expertise to compound animal medications. You need to make sure your veterinarian is using a pharmacist that has this specialized knowledge and training; otherwise, it could be very harmful to your animal and even result in the death of that animal. Also ask the veterinarian about the testing of the compounds.  If the veterinarian doesn't know ask him or her to find out, or ask the question directly to the the pharmacists. Ask as many questions as you can think to ask about compounded preparations that will be used on your animal--it could save your animals life.

House to debate tougher rules for Mass. compounding pharmacies

House to debate tougher rules for Mass. compounding pharmacies