Ned Milenkovich, PharmD, JD
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]
FDA-mandated REMS now in force in pharmaceutical industry
The FDA can require risk evaluation and mitigation strategies for certain prescription drugs and biological products, to ensure that the benefits of such products outweigh the risks. The effect of REMS ripples down through the supply chain to affect how pharmacies dispense medication.
September 26 rollback of wholesale drug prices approaching fast
With the settlement of the class-action lawsuit brought against First DataBank and McKesson by third-party payors accusing the companies of conspiring to inflate average wholesale prices (AWP) of hundreds of drugs, AWP values will roll back from 1.25 to 1.20 times the drugs' wholesale acquisition cost (WAC).
Rogue Internet pharmacies face new penalties
The death of a teenager led Congress to pass the Ryan Haight Online Pharmacy Consumer Protection Act in 2008, amending the Controlled Substances Act to prohibit delivery, distribution, or dispensing of controlled substances over the Internet without a valid prescription.
Pharmacy licensure
As technology and professional innovation both evolve, the pharmacy profession is moving into areas of patient treatment that go beyond the traditional dispensing of drugs to patients in a retail setting. Every dispensing pharmacy must ensure that it possesses the requisite license for any expanded business activity in which it is engaged.