The Main Street Family Pharmacy and the company's co-owner and licensed pharmacist, David A. Newbaker, each pleaded guilty to a misdemeanor criminal violation of the federal Food, Drug, and Cosmetic Act for adulterated Methylprednisolone Acetate, a steroid used to treat pain. FDA's Denver Laboratory tests showed the MPA sample contained bacterial contaminants. During the relevant time period, Newbaker's responsibilities included actively directing drug compounding activities, overseeing employee training, and the quality control of sterile drugs compounded by Main Street.
The federal court sentenced Newbaker to 12 months of probation and ordered him and Main Street to each pay a fine of $25,000. The court also entered a civil consent decree of permanent injunction against Main Street, Newbaker and the company's other co-owner, Christy R. Newbaker. The injunction prohibits, among other things, Main Street and the Newbakers from manufacturing, holding, and distributing drug products until the company comes into compliance with the FD&C Act and its regulations.
This case shows some of the tools available to the Department of Justice and the FDA when contaminated compounded drugs have the potential to effect the health and safety of the public. All owners, PICs, and others overseeing compounding activities need to be aware of this case.
For additional information here are other links regarding this case:
Main Street Pharmacy Co-Owner Pleads Guilty To Criminal ...
www.justice.gov/.../12-11-2014.html
United States Department of Justice
The Law of Compounding Medications And Drugs: Main ...
www.lawofcompoundingmedications.com/.../main-street-family-pharma...4 days ago - Main Street Family Pharmacy Still Involved in Federal Civil Litigation trict of Louisiana (New Orleans) CIVIL DOCKET FOR CASE ...Pharmacy co-owner pleads guilty to violating an FDA Act
www.jacksonsun.com/story/...to...act/20253713/The Jackson Sun21 hours ago - Newbaker, a state-licensed pharmacist, was responsible for, and actively directed, Main Street Family Pharmacy, LLC's drug compounding ...FDA resolves criminal and civil actions against Main Street ...
www.fda.gov/.../ucm425800.htmFood and Drug AdministrationDec 4, 2014 - Main Street Family Pharmacy, LLC, a compounding pharmacy in Newbern, ... violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).TN Drug Compounding Firm Pleads Guilty By Walter F ...
https://plus.google.com/.../posts/YjvChRuxWbpDec 5, 2014 - By Walter F. Roche Jr. A Tennessee pharmacist and hiscompounding firm have pleaded guilty to violations of federal law in the shipping of a spinal steroid across ...Compounding - News - National Association of Boards of ...
https://www.nabp.net/.../com...National Association of Boards of PharmacyImplementation Information for New Compounding Law Available .... FDA Confirms Presence of Microbial Growth in Main Street Family Pharmacy Products. The Law of Compounding Medications And Drugs: FDA ...
www.lawofcompoundingmedications.com/.../fda-resolves-criminal-and-c...Dec 4, 2014 - Main Street Family Pharmacy, LLC, a compounding pharmacy in Newbern, Tennessee, and the company's co-owner, David A. Newbaker, each ...- www.tennessean.com/story/news/.../12/.../19947247/The Tennessean7 days ago - Main Street Family Pharmacy and its owner, David A. Newbaker, each ...comes into compliance with the federal law and federal regulations.
Compound Pharm Pleads Guilty To Shipping Tainted Steroids
www.law360.com/.../compound-pharm-pleads-guilty-to-shippin...Law3607 days ago - Compounding pharmacy Main Street Family Pharmacy LLC and its ... of the Federal Food, Drug and Cosmetic Act for shipping contaminated ...
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