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Showing 4 posts in Pharmacists.

The Compounding Regulations Surrounding Drug Compounding

Posted In Pharmacists

Drug compounding as a practice has, until recently, been met with far looser regulation than the manufacture of drugs. This practice serves to meet the needs of individuals who require certain formulations not available in manufactured form, such as discontinued medications or forms of manufactured drugs that do not contain ingredients to which a patient might be sensitive. Compounding may also change the form of the drug for patients who cannot take manufactured drugs in the manner in which they exist commercially. As industrial-level compounding grows to provide larger amounts of compounded drugs, regulators are scrambling to ensure the quality and safety of these drugs. More >

Pharmacists: Aren’t you really providers already? – Part Two

The first part of this article discussed pharmacist provider status and argument both for and against it. Today’s post now turns to regulatory hurdles, developments towards provider status and the acknowledgment of changing roles in the pharmacist workforce. More >

Controlling Compounding: The Drug Quality and Security Act, Part II

Earlier this week we discussed the new Drug Quality and Security Act (“DQSA”) that establishes and regulates a new class of compounding pharmacies called “outsourcing facilities.”  To qualify as an “outsourcing facility”, the entity must compound sterile drugs with or without patient prescriptions and comply with the DQSA’s new rules, including registering with the FDA.  An outsourcing facility is not required to be a licensed pharmacy.  Registering as an outsourcing facility is completely voluntary, but entities that do not register may be prohibited from compounding drugs for office use and will be required to obtain prescriptions for individual patients. More >

Controlling Compounding: The Drug Quality and Security Act

In October 2012, a fatal meningitis outbreak killed 64 people in the United States and infected more than 750 in 20 states. The outbreak was traced back to contaminated vials of an injectable painkilling steroid that was compounded by the New England Compounding Center (“NECC”). More >

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