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 or drugs that are specifically designed for their individual needs. Compounding pharmacies, whether in neighborhoods or hospitals across America, deliver personalized medicines ... today. Our fundamental goal at Imprimis is patient access to personalized medicine, including increasing the number of prescriptions that are compounded. We believe the best way to make this happen is to address perceived quality issues related to compounding and work with the third-party payer market. While the vast majority of compounding pharmacists operate under the highest of standards and are vitally important to their communities, this Bill takes a positive step in the right direction to encourage increased quality throughout the industry. If compounding pharmacies embrace the trend towards increasing quality, we believe the result will be more patients gaining access to vitally important compounded drug formulations."Working alongside leading physicians and compounding pharmacists, Imprimis has acquired intellectual property for proprietary formulations in four key therapeutic areas: Ophthalmology, Wound Management, Urology and Pain. The company plans to begin development and commercialization activities in these areas in 2014, while continuing to advance the expansion of its proprietary compounded drug and drug delivery vehicle formulations.