House Passes Bill to Regulate Drug Compounding
EMSL Analytical provides sterility and USP Monograph testing in our FDA registered and DEA licensed laboratory.
According to The Energy and Commerce Committee, an agreement on legislation has been reached between the Senate and House committees that regulate health policies in order to improve the safety of compounding drugs and the U.S. pharmaceutical supply chain.
Since the 2012 fungal meningitis outbreak, that infected hundreds of people and killed dozens, the government has made an effort to improve drug safety and help prevent future outbreaks. This legislation, known as the Drug Quality and Security Act, will clarify the regulation of drug compounding to help protect the health and safety of Americans.
The bill will allow the U.S. Food and Drug Administration, FDA, to have a broad oversight of compounding pharmacies. Additionally, the bill includes a tracking system from the manufacturer to the pharmacy in order to prevent counterfeit drugs from entering the supply chain.
“It is crucial to patient’s health and safety for compounding pharmacies to provide sterile drugs and perform Sterility and USP Monograph on their products and active pharmaceutical ingredients periodically,” states Diane Miskowski, MPH, Business Development Manager at EMSL Analytical, Inc. “EMSL Analytical, the nation’s leading environmental testing laboratory, operates an FDA registered, DEA licensed, and ISO 17025 compliant laboratory to assist compounding pharmacies in complying with USP 797 standards.”
About EMSL Analytical, Inc.
EMSL Analytical is a full service testing company providing quality lab services under the same private ownership since 1981. Including the corporate lab facility in Cinnaminson, NJ, EMSL Analytical operates over thirty laboratories nationwide in the US and Canada. We provide analytical services for environmental, indoor air quality (IAQ), industrial hygiene, forensics and materials science, consumer products, food safety, PCR, pharmaceutical, asbestos, lead, and radiological samples. The company has an extensive list of accreditations from leading organizations, as well as state and federal regulating bodies.
- Contact Information
- Joseph Frasca
- Senior Vice President of Marketing
- EMSL Analytical
- (1) 1-800-220-3675
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