Plan B sees increase in Rx-to-OTC availability
NEW YORK Over-the-counter availability of Plan B has increased access to the emergency contraceptive, a survey published in the November issue of the American Journal of Obstetrics & Gynecology reported.
The survey, originally published online June 16, found that only 8 percent of pharmacies were unable to provide Plan B within 24 hours in 2007, as compared to 23 percent of pharmacies that were unable to produce the emergency contraceptive in 2005. And the total refusal rate in 2007 was half that in 2005, 2 percent vs. 4 percent.
The Food and Drug Administration approved the Rx-to-OTC switch of Plan B in 2006.
Pharmacists from Atlanta and Philadelphia were interviewed at 1,087 pharmacies in 2005 and at 795 pharmacies in 2007.
ScriptPro wins FDA database contract
MISSION, Kansas The U.S. Food and Drug Administration has awarded a contract to ScriptPro USA Inc. to provide a searchable drug database for the agency’s internal use.
The data will be based on the drug information resource provided by ScriptPro to support its pharmacy automation systems, and will include all prescription and over-the-counter drug products available for human use in the United States.
Behind the FDA’s decision: ScriptPro’s deep and wide-ranging information capabilities. The pharmacy technology and robotics firm says it develops and maintains the largest and most complete electronic image database of drug and over-the-counter products.
Among the features the FDA is looking for: on-screen images of drugs and drug packaging for verification; data on all versions of each drug released in the market, including images, markings and other descriptive elements; auxiliary warning labels applicable to the products; and drug-specific alerts including FDA black box warning labels.
ScriptPro said it will work “closely with pharmaceutical and OTC manufacturers to incorporate new products and changes into the database,” and will monitor the agency’s internal records and provide information to keep FDA data current.
Fashion Sanctuary recalls weight loss capsules after FDA alert of undeclared additive
SAN DIEGO Fashion Sanctuary on Sunday recalled all lot codes of Zhen De Shou Fat Loss Capsules sold in 10 count blister cards. The recall was initiated after notification by the Food and Drug Administration that lab analysis of Zhen De Shou samples found the product to contain undeclared sibutramine, making it an unapproved drug, the company said.
Sibutramine is a prescription drug used as an appetite suppressant for weight loss. This poses a potential threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
The product was primarily distributed in the United States and sold via Internet. It is sold in a box with an inner foil pouch. Inside the pouch is a blister pack containing light and dark green capsules. This recall affects all lot codes and use by dates. No illnesses or injuries have been reported to date in connection with this product, Fashion Sanctuary reported.