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OIG Bulletin on Excluded Providers: Impact on Pharmacies and Medical Practices

On May 8, 2013, the OIG issued a “Special Advisory Bulletin on the Effect of Exclusion from Participation in Federal Health Care Programs” This “Special Advisory” reiterated and clarified the obligations of providers to assess the status of individuals and entities that they employ or engage to provide services to federal healthcare programs. The implication of utilizing excluded providers can be severe. The Special Advisory describes the scope and effect...

Bi-Partisan Senators Introduce New Bill to Regulate Compounding: The Pharmaceutical Compounding Quality and Accountability Act

On May 15, 2013, bi-partisan legislation was introduced to establish a new framework for compounding regulation. The Pharmaceutical Compounding Quality and Accountability Act (“PCQAA”) was introduced by Senators Tom Harkin (D-Iowa), Lamar Alexander (R-Tenn.), Pat Roberts (R-Kan.), and Al Franken (D-Minn.), which largely followed the recommendations of FDA Commissioner, Dr. Margaret Hamburg, and seek to clarify oversight of compounding and the FDA’s role. The draft legislation encompasses six major areas...

The Federal Government Issues New Rules Increasing Pharmacies Obligation to Protect Patient Information

The U.S. Department of Health and Human Services (HHS) issued new rules (Final Rule) established under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Health Information Technology for Economic and Clinical Health Act (HITECH) implementing some of the most sweeping changes to HIPAA since its inception fifteen years ago. The Final Rule requires every healthcare provider (Covered Entity), which includes pharmacies, to modify their current compliance...

FDA Releases Results of 483 Inspections of Compounders; Contemplating Enforcement Proceedings

The FDA has released an announcement regarding its recent inspections of 31 sterile compounding pharmacies across the United States. The purpose of these inspections was to determine whether certain pharmacies that were known to have produced high-risk sterile drug products in the past posed a significant threat to public health from poor sterile drug production practices. As a result of these inspections, the FDA has issued a list of inspectional...

How Will State and Federal Law Alter Compounding in 2013?

Every compound pharmacy should be preparing for the passage of new Federal and State laws and regulations addressed specifically to compounding. This article focuses on anticipated Federal legislation. Expect a State law update soon. The strongest predictor of Federal laws impacting compounders, can be found in a March 23, 2013 statement by FDA Commissioner, Margaret A. Hamburg, M.D. In the statement, Dr. Hamburg expressed the FDA’s condolences for the families...