White House proposes $215 million, new regs for precision medicine

White House proposes $215 million, new regs for precision medicine

The White House is proposing $215 million in new funds and new regulations in a sweeping effort involving the NIH, the FDA and the ONC to help fulfill the promise of what President Barack Obama has termed precision medicine.  READ MORE

FDA Enforcement Reports January 28, 2015 (a number of sterility issues with Walgreens Infusion Services Products)

Enforcement Reports January 28, 2015

FDA CVM Guidance for Industry Guidances Under Development for 2015 (including possible guidance for animal compounds)

Guidance for Industry Guidances Under Development for 2015

United States enters consent decree prohibiting illegal distribution of Luvena Prebiotic products January 30, 2015

For Immediate Release

January 30, 2015

Release

At the request of the U.S. Food and Drug Administration, a federal judge from the U.S. District Court for the Central District of California today entered a consent decree of permanent injunction against Laclede, Inc. of Rancho Dominguez, California, and its president, Michael A. Pellico. Laclede is the manufacturer of Luvena Prebiotic products.

The consent decree broadly prohibits Laclede from distributing unapproved or improperly labeled (misbranded) drugs and devices in interstate commerce. This action follows a complaint for permanent injunction that the U.S. Department of Justice filed at the request of the FDA on June 25, 2014. The complaint alleged that the company was illegally distributing over-the-counter vaginal drug products without required FDA approval, despite repeated warnings. The products in question were:

• Luvena Prebiotic Vaginal Moisturizer & Lubricant
• Luvena Prebiotic Feminine Wipes
• Luvena Prebiotic Enhanced Personal Lubricant
• Luvena Prebiotic Daily Therapeutic Wash 

The consent decree entered today specifies, among other things, that Laclede may not market any products that contain the term “prebiotic” or “actibiotic” on its labels or packages without obtaining the FDA’s approval. In addition, Laclede may not market any of its products currently the subject of premarket notifications submitted per section 510(k) of the Federal Food, Drug, & Cosmetic Act, including those referencing “lubrication.” 

“The FDA’s drug approval and device clearance processes are essential to ensuring that medical products marketed in the United States are safe and effective for their intended use,” said Melinda K. Plaisier, the FDA’s associate commissioner for regulatory affairs. “The FDA will take strong enforcement action whenever companies attempt to bypass these critical processes.”

For five years following the consent decree, Laclede must also notify the FDA before it markets any new Luvena product and before it modifies any Luvena product labeling. Laclede may not market such products until the FDA notifies the company that it is in compliance with the law.

If the FDA determines that Laclede fails to comply with the consent decree, the agency may take appropriate measures to ensure compliance, including ordering the company to cease manufacturing and distributing its products, recall its products or pay liquidated damages.        

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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Third Question of the Day January 29, 2015 Is the 72 hour in California for Veterinary Compounded Preparations a good rule that all states should have in place? Why or why not?

for a discussion of the 72 hour rule see Compounded Medications and Veterinary Practice:Important Laws, by Grant Miller, DVM, CVMA Director of Regulatory Affairs

Georgia Vet College to Host Conference in March

Georgia Vet College to Host Conference in March

Second Question of the Day January 29, 2015 If there is so much confusion in the compounding industry about office use, MOUs, the drug lists etc. why does there appear to be more hiring going on than ever? Doesn't is seem more like compounding pharmacies are doing more business than ever after the DQSA? Is this because consumers are demanding compounded drugs? If not, what is the reason?

Medisca is Hiring

Compounding Pharmacist

Medisca - Arizona - +7 locations

Provide Direction on Pharmacy Compounding. If you feel that you have the skills required for this Compounding Pharmacist position and would like to join the... 5 days ago - save job - email - more...

Account Executive - new

Medisca - Colorado

Identify key accounts and successfully convert their business to MEDISCA. Gather information on compounding needs, close sales & forecast future requirements.... 3 hours ago - save job - email - more...

Production Technician

MEDISCA - Irving, TX - +1 location

We recognize that our success as a quality-assured supplier of compounding equipment depends on our employees; If you feel that you have the skills required for... 7 days ago - save job - email - more...

Outside Sales Representative

Medisca - Denver, CO

Identify key accounts and successfully convert their business to MEDISCA. Gather information on compounding needs, close sales & forecast future requirements.... 1 day ago - save job - email - more...

Warehouse Clerk

MEDISCA - Irving, TX

We recognize that our success as a quality-assured supplier of compounding ingredients, equipment and devices depends on our employees;... 7 days ago - save job - email - more...

Pharmacy Technician with Prior Authorization & Non-Sterile C... - new

Advanced Rx Management - Hattiesburg, MS

Medisca, Freedom or PCCA compounding training certification a plus. Serves as a coach or trainer to other compounding pharmacy technicians when designated.... Easily apply 3 hours ago - save job - email - more...

Fagron Is Hiring

Sales Manager

Fagron, Inc. - Saint Paul, MN

FAGRON OFFERS A COMPREHESIVE BENEFITS PACKAGE, WHICH INCLUDES:. Is currently seeking a Sales Manager to join our talented sales team, and lead our sales efforts... Easily apply 2 days ago - save job - email - more...

Quality Control Analyst

Fagron, Inc. - Saint Paul, MN

Fagron is a professional and ambitious company with multiple growth opportunities. Fagronintends to further reinforce its market leadership with an active buy... Easily apply 2 days ago - save job - email - more...

Purchasing Supervisor

Fagron, Inc - Saint Paul, MN

Fagron is a young, professional and ambitious company with multiple growth opportunities.Fagron intends to further reinforce its market leadership with an... Easily apply 9 days ago - save job - email - more...

Vice President of Sales and Marketing

Fagron North America - Miami, FL - Miami, FL 33131 (Downtown area)

This role reports to the Executive Vice President of Fagron North America and will be part of the executive team at the Fagron North America corporate... International Academy of Compounding Pharmacists - 22 days ago - save job - email - more...

Vice President of Procurement

Fagron North America - Miami, FL - Miami, FL 33131 (Downtown area)

This role reports to the Executive Vice President Fagron North America and will be part of the Executive team at the Fagron North America corporate headquarters... International Academy of Compounding Pharmacists - 22 days ago - save job - email - more...

Diamondback Drugs is hiring

Inside Sales/Customer Service Representative

Diamondback Drugs  4 reviews - Scottsdale, AZ 85251 (South Scottsdale area)

Diamondback Drugs is the leader in custom compounding for veterinary prescribers and patients nationwide. Under general supervision of the National Sales &... Jobing - 9 hours ago - save job - email - more...

Pharmacist

Diamondback Drugs  4 reviews - Scottsdale, AZ 85251 (South Scottsdale area)

Post by Jobing - Diamondback Drugs is the leader in custom compounding for veterinaryprescribers and patients nationwide.... Jobing - 5 days ago - save job - email - more...

Pharmacy Tech Inventory Specialist

Diamondback Drugs  4 reviews - Scottsdale, AZ 85251 (South Scottsdale area)

Post by Jobing - Diamondback Drugs is the leader in custom compounding for veterinaryprescribers and patients nationwide.... Jobing - 9 hours ago - save job - email - more...

Assistant Inventory Control Specialist

Diamondback Drugs  4 reviews - Scottsdale, AZ

Diamondback Drugs is the leader in custom compounding for veterinary prescribers and patients nationwide. Managing all bulk transfers from chemical storage to... CareerBuilder - 23 days ago - save job - email - more...

Certified Pharmacy Technician

Diamondback Drugs  4 reviews - Scottsdale, AZ 85251 (South Scottsdale area)

Post by Jobing - Diamondback Drugs is the leader in custom compounding for veterinaryprescribers and patients nationwide.... Jobing - 5 days ago - save job - email - more...

Certified Pharmacy Tech

Diamondback Drugs  4 reviews - Scottsdale, AZ

Diamondback Drugs is the leader in custom compounding for veterinary prescribers and patients nationwide. Compounding experience a plus for Compounding position... CareerBuilder - 17 days ago - save job - email - more...