PR Newswire
SAN DIEGO, Nov. 19, 2013 /PRNewswire/ -- Imprimis Pharmaceuticals, Inc. (IMMY), a pharmaceutical company focused on commercializing novel drug formulations invented by physicians and pharmacists through their clinical experience with patients, today voiced support for the U.S. Senate's approval of the Drug Quality and Security Act (H.R. 3204), which clarifies and strengthens the regulatory framework for compounding pharmacies.
"Passage of this Bill by the Senate by a voice vote, after the House's approval in September, has the promise of being a good step forward for patients, physicians, pharmacists and third-party payers," said Mark L. Baum, Chief Executive Officer of Imprimis. "The Bill respects the rights of compounding pharmacies to serve their communities in nearly the same way they did prior to the passage of the Bill, while clarifying and strengthening laws related to drug compounding."
The Drug Quality and Security Act, which must be signed into law by President Obama, addresses several public concerns about compounding pharmacies. Importantly, under the Bill a pharmacy engaged in preparing sterile compounded drug formulations may voluntarily elect to register as an "outsourcing facility," a new entity permitted to compound large quantities of drug formulations on the U.S. Food and Drug Administration's drug shortage list, and other formulations compounded with drug substances that are on a "clinical need" list to be established by the FDA, without a prescription, as well as distribute these formulations out of state without limitation. Entities voluntarily registering as outsourcing facilities would be subject to GMP requirements and regular FDA inspection. The Bill also provides for better communication between state and federal regulators and mandates that drugs prepared by outsourcing facilities bear a label indicating they were compounded.
Baum continued, "More and more, patients expect personalized medicines