California Board of Pharmacy Takes Action Against 4 Compounding Pharmacies During Last Couple of Months

Site Licenses

Advanced Compounding Pharmacy, PHY 48591 and LSC 99426, Administrative Case AC 3251
North Hollywood, CA
Through a disciplinary action of the board, the license is revoked, the revocation is stayed and the license is placed on probation for five years.  The terms and conditions of probation include posted notice of probation, development and approval of all master formulas, validation process and restrictions on compounding the first year of probation.  Decision effective 7/8/2013.
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Grandpa's Compounding Pharmacy, LSC 99109, Administrative Case AC 4929
Placerville, CA
Cease and desist immediately from compounding sterile injectable drug products. Effective 9/10/2013.
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Santa Clara Drug “The Compounding Shop”, PHY 51229, Administrative Case AC 4842
San Jose, CA
Through a disciplinary action of the board, the license is revoked, the revocation is stayed and the license is placed on probation for five years. The terms and conditions of probation are set forth in the final order of the board. Decision effective 8/20/2013.
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Specialty Compounding LLC, NRP 1021
Cedar Park, Texas
Cease and Desist from furnishing sterile injectable compounded products.  Effective 8/9/2013.
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The Compounding Shop, Inc., St. Petersburg, FL more recent 483 issued 9/3/2013 along with two other 483s

• The Compounding Shop, Inc., St. Petersburg, FL, 483 Issued 9/3/2013 (PDF - 97KB)
• The Compounding Shop St. Petersburg, FL, 483 Issued 3/22/2013 (PDF - 1.3MB)
• The Compounding Shop St. Petersburg, FL, Amended 483 Issued 3/25/2013 (PDF - 10MB)

FDA Inspection Triggers Recall of ALL Sterile Products Made by Florida Pharmacy

By MATTHEW PERRONE AP Health Writer

WASHINGTON May 11, 2013 (AP)

The Food and Drug Administration warned doctors and pharmacists Wednesday to avoid drugs made by a Florida specialty pharmacy called The Compounding Shop, due to potential safety problems uncovered by health inspectors.

The St. Petersburg, Fla.-based pharmacy has agreed to recall all of its sterile drugs and is in the process of notifying customers, the FDA said in a statement. The agency said health care professionals should quarantine drugs from the company and not administer them to patients.

The Compounding Shop is a compounding pharmacy, which means it mixes custom formulations of drugs to meet doctors' specifications. In recent weeks the FDA has cracked down on compounding pharmacies across the country, triggering several national recalls.

The wave of inspections comes in the wake of a nationwide fungal meningitis outbreak last year tied to contaminated drugs from a Massachusetts pharmacy. The outbreak sickened more than 700 Americans and killed more than 50 others.

The FDA said a recent inspection of The Compounding Shop raised concerns about sterility problems with company drugs that could lead to bacterial contamination.

"If an injectable drug product that is intended to be sterile is contaminated, it could result in a life-threatening infection in patients," said Janet Woodcock, director of FDA's drug center, in a statement.

Patients who received products form the pharmacy and have concerns should contact their doctor.

Source found here

Press Announcements FDA alerts health care providers of lack of sterility assurance of drug products from The Compounding Shop

Press Announcements FDA alerts health care providers of lack of sterility assurance of drug products from The Compounding Shop