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NABP e-News: November 25, 2009
Proposed Placement of Carisoprodol Into Schedule IV
The Deputy Administrator of the Drug Enforcement Agency (DEA) issued a proposed rule to place the substance carisoprodol into Schedule IV of the Controlled Substance Act. This proposed rule is based on a recommendation from the Department of Health and Human Services and on an evaluation of the relevant data by DEA. Data from several databases shows that carisoprodol is abused in the United States. A number of states regulate carisoprodol under their controlled substance regulations. Written comments regarding the proposed federal rule must be submitted and postmarked by December 17, 2009 or submitted electronically before midnight EST on December 17. More information is available in the Federal Register and can be accessed at Regulations.gov using docket number DEA-333.
Recent Reports of DEG Poisonings Prompt Reminder to Consult Guidance Document
Due to recent reports on diethylene glycol (DEG) poisonings associated with contaminated glycerin in pharmaceutical syrups, Food and Drug Administration (FDA) advises practitioners to consult the 2007 “Guidance for Industry Testing of Glycerin for Diethylene Glycol.” The guidance recommends certain precautions should be taken to prevent use of glycerin, or other excipients, such as propylene glycol, contaminated with DEG. FDA has no reason to believe that the US supply of glycerin is contaminated with DEG, but a number of deaths resulting from DEG-contaminated glycerin have been reported in other countries. FDA advises that pharmacy compounders using glycerin to prepare drug products either test for DEG content or ensure that testing was properly done by the supplier. Information on excipients at risk for DEG contamination can be found in a United States Pharmacopeia bulletin. FDA requests that related complaints or adverse events be reported to MedWatch.
FDA Warns Web Site Operators and Operation Pangea Intercepts Suspicious Drug Packages
The International Internet Week of Action (IIWA) coordinates the efforts of domestic and international regulatory and law enforcement agencies to curb illegal Internet drug sales and fight counterfeit medications. As part of IIWA, the FDA issued 22 warning letters to Web site operators that appear to be illegally selling unapproved or misbranded drugs to consumers in the United States. FDA also notified Internet service providers and domain name registrars that the Web sites were selling products in violation of US law; such violations can be grounds for terminating Web sites and suspending domain names. IIWA, code named Operation Pangea II, also coordinated domestic and international law enforcement efforts, which targeted and intercepted international shipments of suspicious pharmaceuticals. According to the Washington Post, United States officers intercepted nearly 800 packages. Interpol reports that international customs agents in 24 countries confiscated 995 packages.
FDA Announces New Warning on Plavix: Avoid Use with Prilosec/Prilosec OTC
In a November 17 news release, FDA warned that patients should avoid using Prilosec/Prilosec OTC (omeprazole) with Plavix (clopidogrel). When used properly both drugs provide significant benefit; however, when taken together, Plavix’s ability to block platelet aggregation may be reduced by about half. Prilosec blocks the liver enzyme CYP2C19, preventing Plavix from metabolizing into its active form, thereby reducing the effectiveness of Plavix. The Plavix label has been updated with warnings regarding treatment with Prilosec and other drugs that may inhibit the CYP2C19 enzyme.
Orange Book Data Through October 2009 Released
The Cumulative Supplement to the Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) has been released. The Orange Book data files are current through October 2009.
Three Additional Facilities Awarded VAWD Accreditation
NABP recently accredited three additional facilities through its Verified-Accredited Wholesale Distributors® (VAWD®) program, bringing the total number of accredited facilities to 378 as of November 19, 2009. A full listing of VAWD facilities is available under Accreditation Programs on the NABP Web site.
- PrePak Systems, Inc provides repackaging of pharmaceutical products. The company received accreditation for its facility in Cookeville, TN.
- Prescription Supply, Inc, located in Northwood, OH, distributes prescription and over-the-counter products primarily to pharmacies in Ohio and Michigan.
- Baxter Healthcare Corporation received accreditation for its facility located in Memphis, TN. This facility distributes only Baxter Healthcare products, including its controlled substances, and distributes primarily to three wholesalers.
