FDA Articles

Pharmaceutical & Medical Packaging News
May 2000

Pharmaceutical Representative, Mar 1, 2003

Applied Clinical Trials, Jul 1, 2001

Non-Hodgkin's lymphomas (NHL) are a diverse group of malignancies that attack the B and T lymphocytes of the immune system. More than 50,000 Americans develop NHL annually, and nearly 50% of them die of the disease. Conventional treatment of NHL is limited to chemotherapy, with burdensome side effects and variable clinical outcomes. If the lymphoma is localized, the choice of therapy is radiation, but targeting external beam radiation to cancerous immune system cells throughout the body is difficult and complex.


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The Office of Combination Products sorts out jurisdictions and opens up communication between FDA center. In medical product regulation, like law enforcement, determining jurisdiction is critical to avoiding confusion and ineffi- ciency. But “border crossings” between drugs, biologics, and devices—categories that follow distinct regulatory paradigms— are making assigning regulatory authority for products more difficult. A relatively new department in the FDA called the Office of Combination Products (OCP) is charged with handling this issue.

Federal health officials issued a final report last month designed to bolster the U.S. Rx drug supply against counterfeiters. Officials said that their plan would focus o­n promoting microchip technology that allows computers to track the movements of drug containers from the manufacturer to the pharmacy. Federal authorities also plan to work with pharmacy groups and state legislatures in an effort to stiffen state licensing requirements for distributors throughout the nation. The Food & Drug Administration reports that its investigations of drug counterfeiting have risen in recent years, though the agency still maintains that prescription drug fakes are rare in this country. Still, officials said that their proposals were key to heading off increasingly brazen and advanced counterfeiters both stateside and abroad. "More than ever, well-organized criminals stand ready to exploit any crack in the country's regulatory system," Health & Human Services secretary Tommy G.

Massoud Lavian and Paul W. Allen, Clarkston Consulting
BioPharm International, November 2002

Trying to protect their ability to compound veterinary drugs, 10 pharmacy owners in six states have filed a federal lawsuit against the Food & Drug Administration for banning the use of bulk ingredients. The suit filed in U.S. District Court for the Western District of Texas alleges that the FDA overstepped its authority when it decreed that it's illegal to use bulk ingredients in the compounding of medications for nonfood companion animals. The current legal battle involves family pets, but the pharmacist plaintiffs are concerned that going after Fido and Fluffy is o­nly the opening gambit in an FDA campaign that would ultimately try to put their human owners off-limits to compounded drugs as well. The seeds of the plaintiffs' legal tussle with the FDA were planted last year when the agency issued the compliance policy guideline (CPG 7125.40 Section 608.400) that outlawed compounding veterinary medicines from bulk ingredients.

Pharmaceutical & Medical Packaging News
November 1999

Pharmaceutical & Medical Packaging News
May 1998