By Ashley A. Noble and Richard Cauchi
In the wake of a 2012-2013 national outbreak of meningitis linked to contaminated compounded medicine, state lawmakers are taking a close look at the systems and standards needed to protect patients.
The vast majority of drugs sold in the United States are manufactured by companies in factories far from where consumers have their prescriptions filled. Each drug is produced uniformly on a mass-scale. Pharmaceutical manufacturers are regulated by the Food and Drug Administration (FDA).
However, some pharmaceutical products are not made by manufacturers, but by compounding pharmacies. Compounding pharmacies compound, or mix, drugs for consumer use, often on-site.
Compounding pharmacies can create customized doses and mixes of drugs, which may be necessary or desirable for a number of reasons. For example, if a patient had an allergy to a component of a manufactured pharmaceutical, or required a dose that is not manufactured for sale, a compounding pharmacy would make customized pharmaceuticals to meet the patient’s needs. In fact, until the mid-20th century, most, if not all, prescription drugs were mixed by a pharmacist. Today, drugs mixed by compounding pharmacies account for an estimated 1 percent to 3 percent of all drugs sold in the United States.
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In the wake of a 2012-2013 national outbreak of meningitis linked to contaminated compounded medicine, state lawmakers are taking a close look at the systems and standards needed to protect patients.
The vast majority of drugs sold in the United States are manufactured by companies in factories far from where consumers have their prescriptions filled. Each drug is produced uniformly on a mass-scale. Pharmaceutical manufacturers are regulated by the Food and Drug Administration (FDA).
However, some pharmaceutical products are not made by manufacturers, but by compounding pharmacies. Compounding pharmacies compound, or mix, drugs for consumer use, often on-site.
Compounding pharmacies can create customized doses and mixes of drugs, which may be necessary or desirable for a number of reasons. For example, if a patient had an allergy to a component of a manufactured pharmaceutical, or required a dose that is not manufactured for sale, a compounding pharmacy would make customized pharmaceuticals to meet the patient’s needs. In fact, until the mid-20th century, most, if not all, prescription drugs were mixed by a pharmacist. Today, drugs mixed by compounding pharmacies account for an estimated 1 percent to 3 percent of all drugs sold in the United States.
continue to read here
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