This article is not intended as legal advice and should not be used as such. When legal questions arise, pharmacists should consult with attorneys familiar with the relevant drug and pharmacy laws.
Ned Milenkovich is chair of the Healthcare Law practice at Much Shelist PC and vice chair of the Illinois State Board of Pharmacy. Contact him at: 312-521-2482 / [email protected]
Many pharmacies are aware of the 340B Drug Pricing Program, but few understand the mechanics of how such a program works and to what extent a community pharmacy may be able to capitalize on its benefits.
A pharmacy that engages in veterinary compounding has been embroiled in a struggle with FDA since it compounded a vitamin supplement for administration to 21 polo ponies during the U.S. Open Polo Championships in April 2009. When they were injected with the compounded vitamin supplement, all 21 ponies collapsed and died. FDA's subsequent court challenge raises the question of when compounding becomes manufacture.
While the government deems that marijuana has a "high potential for abuse" and "has no currently accepted medical use," some states have undertaken initiatives to pass legislation permitting its use for pain control and for control of nausea and vomiting by cancer patients.
Pharmacies are experiencing financial, regulatory and reimbursement challenges that have increased pressure on their operations. A regular review of financial circumstances and business options can help pharmacies stay afloat in turbulent times.
The American Recovery and Reinvestment Act, signed into law on February 17, included the Health Information Technology for Economic and Clinical Health Act (HITECH), which expands covered-entity and business-associate requirements established by the Health Insurance Portability and Accountability Act of 1996 (HIPAA).