The bicameral legislation provides specific requirements for all stakeholders in the drug-distribution supply chain, including manufacturers, wholesalers, repackagers, and pharmacies.
Ned Milenkovich, PharmD, JD
Federal agencies have fined an LTC provider $50 million for improperly dispensing controlled substances.
DEA published its interim final rule on e-prescribing for controlled substances (EPCS) more than two years ago. While vendors work toward compliance, nationwide deployment of EPCS can only occur once both state and federal laws are aligned in all jurisdictions.
The Office of Inspector General has issued a report implicating more than 2,600 pharmacies in Medicare Part D fraud
NABP has launched an initiative to transfer prescription monitoring program information across state lines
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).
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.
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).
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.