Seizure at Professional Compounding Centers of America ___________________________________
On June 15, 2006, the U.S. Marshals Service, accompanied by investigators from FDA's Dallas District Office, executed a seizure warrant at Professional Compounding Centers of America (PCCA), Houston, Texas, seizing over 300 bottles/vials, of various size, consisting of four bulk active pharmaceutical ingredients (APIs) (domperidone, polidocanol, enrofloxacin, and insulin beef powder), that were repacked by PCCA as bulk APIs intended for sale to pharmacies for use in compounding human and veterinary drug products. FDA considers the articles of drug at PCCA to be misbranded because they are intended for use in formulating finished human drugs (domperidone and polidocanol) and finished animal drugs (insulin beef powder and enrofloxacin) and their labeling does not bear adequate directions for such uses. They are not exempt from this requirement because they are intended for use in making articles that are unapproved new drugs for human use and unapproved new animal drugs.
FDA seized the domperidone and polidocanol because the agency is concerned about the public health risks associated with the compounding of drugs containing these APIs. No drugs containing these APIs are currently approved in the United States. FDA does not sanction the use of these APIs in the compounding of human drugs. FDA issued a letter to PCCA in June 2004, warning the firm to cease distributing the API domperidone and conveying FDA's public health concerns.
FDA Issues Warning Letter for Distribution of APIs for Pharmacy Compounding ______________________________ On November 28, 2005, FDA’s New Jersey District Office issued a Warning Letter to the Chief Executive Officer of Spectrum Chemicals and Laboratory Products, Inc. (Spectrum Chemicals) Tucson, Arizona, after an FDA inspection of the firm’s New
Brunswick, New Jersey facility revealed that the firm received active pharmaceutical ingredients (APIs), including polidocanol, from manufacturers and distributors and repackaged and relabeled them for distribution to pharmacies for compounding. FDA is very concerned about the public health risks associated with compounded polidocanol. Polidocanol is not an active ingredient contained in any FDA-approved drug product. FDA does not sanction its use in pharmacy compounding. FDA considered the articles of drug at Spectrum Chemicals to be misbranded because they are intended for use in formulating finished human drugs and their labeling does not bear adequate directions for such uses. They are not exempt from this requirement because they are intended for use in making articles that are unapproved new drugs.
Furthermore, the list of APIs produced during the inspection indicated that Spectrum Chemicals was distributing adenosine-5-monophosphate to pharmacies for compounding. Drugs containing adenosine-5-monophosphate were removed from the market in 1973, for safety reasons.
Spectrum Chemicals was warned in June of 2004 that the firm may not distribute APIs for compounding that are not components of approved drugs. That Warning Letter was based on the firm’s distribution of the API domperidone for use in compounding human drugs. The firm was advised that domperidone was not a component of an FDA-approved drug and the agency does not tolerate its distribution for human drug compounding. The November 2005 Warning Letter noted that the fact that the firm continued this practice is extremely troubling.
The full text of the Warning Letter is available online at: http://www.fda.gov/foi/warning_letters/g5649d.htm.
Warning Letter Issued to Pharmacy Compounding Firm ___________________________________ On February 15, 2006, FDA’s New Orleans District Office issued a Warning Letter to the President and Owner of Southern Meds Joint Venture, LLC (Southern Meds), Biloxi, Mississippi. On August 3-5 and 11, 2005, an FDA investigator inspected the Southern Meds facility, located in Biloxi, Mississippi, and documented serious violations of the FD&C Act. FDA’s inspection revealed that the firm manufactures thirteen injectable drug products, eight of which had the same strength as other commercially available products.
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The Warning Letter noted that, "For the purpose of the agency's exercise of its enforcement discretion, the availability of different size vials are not a meaningful distinction between your products and the commercially available products. Further, FDA found no documentation of the medical need for the variation between solutions and suspensions.’
The Warning Letter also noted that FDA does not believe the firm's production volume is consistent with that of a traditional pharmacy compounding operation.
In addition, the inspection found significant violations of the current good manufacturing practice (CGMP) regulations for a drug product. The CGMP violations included, but were not limited to, the following:
• Failure to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile;
• Failure to have control systems to prevent contamination;
• Failure to have written standards or specifications and methods of testing to remove pyrogenic properties;
• Failu
appropriate laboratory determination of satisfactory conformance to final specifications; and,
• Failure to prepare and maintain batch production and control for each batch of prescription injectable drug product produced by this firm.
The full text of the Warning Letter is available online at: http://www.fda.gov/foi/warning_letters/g5719d.htm.
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FDA Warns Three Pharmacies to Stop Mass-Producing Unapproved Inhalation Drugs _____________________________________ Compounding Mass Amounts of Inhalation Drugs Extends Well Beyond Traditional Pharmacy Compounding
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re to test each batch of drug product purporting to be sterile by
that are not commercially available, such as a unique medicine for a patient who is allergic to an ingredient in an FDA-approved drug. This kind of compounding follows a physician's decision that his or her patient has a special medical need that cannot be met by FDA-approved drugs.
FDA normally permits traditional pharmacy compounding and is not targeting this practice.
The three firms were making inhalation drugs that are used to treat diseases including asthma, emphysema, bronchitis, and cystic fibrosis. These are potentially life-threatening conditions for which numerous FDA-approved drugs are available. FDA noted in a Press Release dated August 10, 2006, that these compounded inhalation drugs may be distributed to patients in multiple states, and patients and their doctors may not know that they are receiving compounded products. FDA urged consumers using inhalation drugs to discuss their medications with their physicians and verify with their pharmacists that the medications they received are what their physicians ordered.
millions of doses of inhalation drugs per year. The full text of the Warning Letter to Rotech Healthcare, Inc., Orlando, Florida is available online at: http://www.fda.gov/foi/warning_letters/g5964d.htm.
quoted from here
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