Regulatory and Washington

WASHINGTON — A bill designed to strengthen the security of the drug supply chain by creating an electronic track-and-trace system and national standards for sterile pharmacy compounding has attracted support from trade groups representing retail pharmacies and generic drug makers.

MISSION, Kan. — ScriptPro's Central Pharmacy Management System Point of Sale can now interface with a real-time system for tracking and controlling OTC products that can be used to manufacture methamphetamine.

ScriptPro said its system now interfaces with the Appriss National Precursor Log Exchange system, currently used by pharmacies and law enforcement agencies in 22 states to track products like pseudoephedrine-based cold and allergy remedies. ScriptPro said the interface eliminates the need to keep a manual log to document sales of the products.

FRANKLIN LAKES, N.J. — Becton, Dickinson and Co. is partnering with the World Health Organization in an effort to address maternal and newborn mortality, BD said Friday.

NEW YORK — Legislation to allow the Food and Drug Administration to strengthen its regulatory powers over compounding pharmacies is expected to pass both houses of Congress after committees agreed on it Thursday, according to published reports.

WASHINGTON — Flu vaccination coverage in children increased dramatically during the last season, with smaller increases in coverage among adults, according to new data from the Centers for Disease Control and Prevention.

In its Morbidity and Mortality Weekly report, the CDC said this week that coverage for children aged 6 months through 17 years during the 2012-2013 season was 56.6%, a 5.1% increase from the 2011-2012 season. Coverage among adults was up by 2.7%, at 41.5%. Some gaps were seen between rates on a state-by-state basis.

PITTSBURGH — Mylan is challenging the patent protection on a drug used to treat fibromyalgia, prompting a lawsuit from the branded drug's manufacturers.

Mylan said Wednesday that Forest Labs and Royalty Pharma had sued it in the U.S. District Court for the District of Delaware in connection with its filing of a regulatory approval application with the Food and Drug Administration for milnacipran hydrochloride tablets in the 12.5-mg, 25-mg, 50-mg and 100-mg strengths. The drug is a generic version of Savella.

GUADALAJARA, Mexico — Looking into a company masquerading adulterated pharmaceuticals as miracle dietary supplements branded Reumofan, USA Today investigative journalists traveled as far as Mexico to find those responsible. 

What they found were fake addresses, misleading ingredient lists and no trace of the parent company. 

SILVER SPRING, Md. — Foods must carry gluten content of less than 20 parts per million in order to carry the label "gluten-free," according to a new regulation issued by the Food and Drug Administration.

The FDA announced the regulation Wednesday, saying the standard would provide consumers with the assurance that "gluten-free" claims on product labeling are consistent and reliable across the food industry; other labels, such as "no gluten" and "without gluten" also would be subject to the new standard.