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Fifth Circuit Medical Center Pharmacy v. Mukasey Decision Creates Circuit Split Over FDCA § 503A Pharmacy Compounding “Safe Harbor"
When Congress enacted the Federal Food, Drug, and Cosmetic Act ("FDCA") in 1938, it required New Drug Applications ("NDAs") for "any" new drug. At the time, approximately half of the drugs in this country were compounded, not manufactured. Today, while the percentage of compounded prescriptions has dropped significantly, millions...READ MORE

Senators Join Thousands of Patients, Doctors, Pharmacists in Supporting Women's Access to Critical Hormone Treatments
The International Acedemy of Compounding Pharmacists (IACP) today [July 15, 2008] joined hundreds of thousands of women and doctors in applauding the introduction of S. Con. Res. 88, a resolution stating that "the Food and Drug Administration's (FDA) new policy restricting women's access to medications containing estriol does not serve...READ MORE

Wedgewood Pharmacy Compounds for the Entire Family - Four-Legged and Otherwise
As a nation, we love our pets. A glance at recent statistics details this love affair. According to the 2007-2008 National Pet Owners Survey, about 63 percent of us own a pet, with dogs slightly edging out cats for most popular animal companions. We pamper them in new and ever more fantastic ways, grooming their fur with celebrity products, serving...READ MORE

Pharmacist Associations Partner to Increase the Voice of Pharmacy
The National Community Pharmacists Association (NCPA) and the International Academy of Compounding Pharmacists (IACP) are collaborating to increase the legislative and regulatory clout of pharmacists who engage in compounding. IACP has established a satellite office at NCPA's headquarters, which is led by their Director of Public Affairs, Sarah R. Dodge. In addition, since both groups share common concerns about...READ MORE

FDA Contradicts Genentech on Eye Drug
An FDA letter to Senate investigators appears to contradict one of Genentech's main reasons for restricting the distribution of its cancer drug Avastin. Last year, the company said it would no longer sell the drug to compounding pharmacies, which repackage Avastin for use in patients with eye disease. In an open letter, the company said it was making the switch in part because the FDA inspectors' concerns that some...READ MORE

Trilostane: A Therapeutic Consideration for Canine Hyperadrenocorticism
More than 85% of dogs have shown both clinical and biochemical improvement (decreased alkaline phosphatase activity and cholesterol concentration) after a month of trilostane therapy, with substantial improvements in post-ACTH stimulation cortisol concentrations. Survival times for patients treated with trilostane (662 to 930 days) compare favorably with those receiving mitotane (708 days)....READ MORE

Patients, Doctors, Pharmacists Praise Bipartisan House Resolution on Compounded Hormones Containing Estriol
The International Academy of Compounding Pharmacists joined hundreds of thousands of women and doctors in applauding the introduction of H. Con. Res. 342, a bipartisan resolution stating that "the Food and Drug Administration's (FDA) new policy restricting women's access to medications containing estriol does not serve...READ MORE

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