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compounding Pharmacies 6 articles

Bayer recalls bacteria filters used in compounding pharmacies

Baxter International Inc., is recalling all unexpired lots of 50mm 0.2 micron filters used to filter bacteria and particulate matter in compounded solutions, such as those manufactured by compounding pharmacies. The recall was initiated because of issues with a component of the filter made by an external supplier, and was identified as a result of complaints from compounding facilities. Without the filter support membrane, the bacteria and/or particulate matter present in an unsterile solution could pass through to the compounded prepared solution. If not filtered again before the product is administered to a patient, this defect could cause adverse health ... Read More

Compounding pharmacy advocacy groups fight FDA’s proposed guidance

Companies and trade groups are putting the heat on the Food and Drug Administration (FDA) claiming the agency’s proposed restrictions on interstate shipments of compounded drugs are confusing and hard to gauge. The concerns were raised following the February publishing of the FDA’s “memorandum of understanding,” or MOU, which proposed policies for state oversight of compounding pharmacies that are not listed as FDA-regulated outsourcing facilities. The public had until July 20 to offer comments on the MOU. A compounding pharmacy is not allowed under the Federal Food, Drug & Cosmetic Act to ship more than 5 percent of its products across state ... Read More

FDA cracks down on compounding pharmacies, issuing warning letters for unsanitary practices

The Food and Drug Administration (FDA) is coming down hard on compounding pharmacies, issuing warning letters for unsanitary conditions and producing drugs without individual prescriptions. The action comes four months after congress passed the Drug Quality and Security Act, which puts compounding pharmacies that outsource their products under FDA oversight instead of being governed by state pharmacy boards like traditional pharmacies. Nora Apothecary and Alternative Therapies, Pallimed Solutions Inc., and Wedgwood Village Pharmacy received warning letters outlining sterility issues with facility procedures from visible sterile drug contaminants to inadequate clean rooms and monitoring programs. The FDA’s oversight into compounding pharmacies ... Read More

Bill requires more government oversight for larger compounding pharmacies

President Barack Obama signed into law new legislation that gives the Food and Drug Administration (FDA) more regulatory control over compounding pharmacies. The move comes 15 months after authorities linked a multistate fungal meningitis outbreak to contaminated steroid shots manufactured and distributed by a Massachusetts-based specialty pharmacy. The new law does not give the FDA as much control over compounding pharmacies as the agency had hoped, but it does give FDA the authority to conduct on-site inspections of pharmacies that mass produce custom-mixed drugs for distribution across state lines. The FDA oversees drug companies that produce pharmaceuticals and over-the-counter medicines. ... Read More

Legislation aims to give FDA greater oversight of compounding pharmacies that mass produce drugs

A bipartisan group of U.S. senators is proposing legislation that would grant the Food and Drug Administration (FDA) greater oversight of pharmacies that compound sterile drugs and ship them across state lines. The proposal comes on the heels of the deadly fungal meningitis outbreak that killed 53 people and sickened at least 733 across 20 states. Medical investigators determined that the outbreak was caused by contaminated steroid shots made by New England Compounding Center (NECC). About 18,000 tainted shots were sent to medical facilities in 23 states, putting an estimated 14,000 people at risk for fungal infections including meningitis. Pharmaceutical ... Read More

Lawmakers call for stricter oversight of compounding pharmacies

Two Democratic lawmakers are calling for stricter federal oversight for compounding pharmacies after a deadly fungal meningitis outbreak was linked to contaminated steroids made by a specialty pharmacy in Massachusetts. Representatives Rosa DeLauro and Edward Markey said in separate statements that they will draft legislation that gives the Food and Drug Administration (FDA) the authority to regulate compounding pharmacies. Compounding pharmacies custom-mix drug ingredients based on a doctor’s prescription. Most are smaller pharmacies, but some have grown into larger businesses that ship products to other states and supply hospitals and other medical facilities. Problems, such as contamination, can arise if ... Read More