A deadly meningitis outbreak and subsequent recalls tied to contaminated compounded drugs shine a light on an unfamiliar aspect of the prescription drug industry.
Compounded drugs are created for patients with unique needs or for whom traditional drug dosages wouldn't or don't work.
Reading Eagle
June 6, 2013
Karen White
Recently, the Food and Drug Administration has stepped up inspections of laboratories where concerns about sterility in the manufacture of injectable drugs could lead to bacterial contamination.
Where most local pharmacies differ from the large compounding pharmacies in question is that Reading-area compounding professionals create topical, oral or suppository mixes, not injections or inhaled drugs.
For what local pharmacists do, a Pennsylvania pharmacy license is required. The labs with clean rooms and other equipment require more specialization.
Scott A. Wertz, owner of the Medicine Shoppe franchise at 1170 Perkiomen Ave., only sells compounded drugs and does not sell traditional prescription drugs in pill or tablet form. But he does not compound injectable drugs, so he does not need a clean room or any of the equipment required for preparing an injectable drug.
What he does, for example, could involve treatment for a newborn baby born with acid reflux, or heartburn. The typical prescription for that condition would be the drug Prilosec, but the size and dose
would not be suitable for a newborn, so a compounding pharmacist would create an appropriate dose to mix into a formula or a beverage for that child.
Dr. Nancy M. Baird, a compounding pharmacist at the Medicine Shoppe, Boyertown, another franchise, said her compounding work can be as simple as creating dye-free Tylenol for patients who cannot tolerate the dye Red 40 commonly used in the drug.
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Compounded drugs are created for patients with unique needs or for whom traditional drug dosages wouldn't or don't work.
Reading Eagle
June 6, 2013
Karen White
Recently, the Food and Drug Administration has stepped up inspections of laboratories where concerns about sterility in the manufacture of injectable drugs could lead to bacterial contamination.
Where most local pharmacies differ from the large compounding pharmacies in question is that Reading-area compounding professionals create topical, oral or suppository mixes, not injections or inhaled drugs.
For what local pharmacists do, a Pennsylvania pharmacy license is required. The labs with clean rooms and other equipment require more specialization.
Scott A. Wertz, owner of the Medicine Shoppe franchise at 1170 Perkiomen Ave., only sells compounded drugs and does not sell traditional prescription drugs in pill or tablet form. But he does not compound injectable drugs, so he does not need a clean room or any of the equipment required for preparing an injectable drug.
What he does, for example, could involve treatment for a newborn baby born with acid reflux, or heartburn. The typical prescription for that condition would be the drug Prilosec, but the size and dose
would not be suitable for a newborn, so a compounding pharmacist would create an appropriate dose to mix into a formula or a beverage for that child.
Dr. Nancy M. Baird, a compounding pharmacist at the Medicine Shoppe, Boyertown, another franchise, said her compounding work can be as simple as creating dye-free Tylenol for patients who cannot tolerate the dye Red 40 commonly used in the drug.
continue reading here