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»  Posts By   November 2014 

CVS/Caremark Implements New Recredentialing Processes for Compounding Pharmacies Requiring Detailed Information and Policies and Procedures

CVS/Caremark has followed in the footsteps of other PBMs and has recently adopted new recredentialing processes for compounding pharmacies. These new recredentialing forms represent a significant change from forms that were previously used for compounding pharmacies going through recredentialing. Citing its need to comply with the Affordable Care Act and State Medicaid requirements, Caremark has tasked many of the PSAOs with ensuring these recredentialing questions are answered by compounding pharmacies....

FDA Provides Clarity on Use of Estriol by Section 503A Compounding Pharmacies

The FDA has recently provided limited additional information in an informal email on whether a pharmacy may use certain bulk drug substances in compounding. Specifically, the FDA has indicated that drug products containing Estriol may be compounded in accordance with Section 503A by a licensed pharmacist pursuant to a patient-specific prescription, based on the fact that Estriol is the subject of an applicable USP monograph. The FDA provided this statement...

Federal Court Dismisses RICO Claims Against Pharmaceutical Manufacturers Over Copayment Assistance Cards

A Federal Judge in the Northern District of Illinois recently dismissed one of several class actions filed against pharmaceutical manufacturers involving the use and marketing of copayment savings card programs or “copay subsidy programs,” as the Court referred to them. The case, New England Carpenters Health and Welfare Fund v. Abbott Laboratories, et al., Case No. 12-CV-01662, involved a class action suit brought by health insurance plan sponsors against Abbott...

Inspection Report Offers Enforcement Insight for Sterile Compounders In California

California continues to increase its oversight of sterile compounding in the State, proposing new regulations and inspecting 58% of the total pharmacy population licensed for sterile compounding (LSC) in a three month period (March 2014- June 2014). Inspection results will likely shape California’s ongoing development of regulations and enforcement strategy, and pharmacies doing business in the State should be guided accordingly. According to a recent report published by ITL Consulting, results...

FDA Regulatory Requirements Continue to Swell

The tide of federal healthcare regulations continues to rise. Healthcare providers need to stay informed. A recent study by George Mason University found that between 2000 and 2012, the number of regulatory requirements imposed by the United States Food and Drug Administration (the “FDA”)—the agency responsible for developing and administering regulations pertaining to pharmaceuticals and medical devices— increased by fifteen (15%) percent. Quantified, the increase represents approximately 2,448 new regulations,...
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