Legal News

The U.S. Food and Drug Administration published two rules recently to help clarify how very ill patients can obtain access to investigational drugs and biologics when they are not eligible to participate in a clinical trial and have no other satisfactory treatment options.

The National Association of Chain Drug Stores and the National Community Pharmacists Association are moving ahead with their lawsuit against Delaware's changes to Medicaid reimbursement rates, even after Walgreen Co. said it no longer supports the suit.

A Miami resident has been convicted of both conspiring to divert human growth hormones and causing the diversion of these human growth hormones in interstate commerce.

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.

Over the next several years, generic versions of many best-selling drugs will become available as patents reach their expiration dates.

Pharmacy mistakes can sometimes lead to injury or even death. Pharmacists can be held liable in a civil suit for money damages; now a pharmacist in Ohio may be convicted of a criminal charge in the accidental death of a two-year-old girl. It is possible that the effect of criminal liability upon professional practices will worsen outcomes rather than improve them.

In coming years, nearly half of all newly approved drugs could come from biotechnology. With stakes so high, Congress is working to create a more direct pathway for the FDA to approve "biosimilars", the generic or "follow-on" versions of biologics. Two bills before Congress approach the issues differently.

The FTC has extended to November the compliance deadline for its "Red Flag" identity theft regulation, affecting all businessess that extend credit to customers.

Iowa proponents have sought legalization of medical marijuana for years. Now the state?s Board of Pharmacy Examiners (IBPE) wants to learn more about the issue.

The National Community Pharmacists Association (NCPA) recently wrote to a key standards-setting body requesting action on a number of regarding a new Internal Revenue Service requirement meant to ensure flexible spending account debit cards are used properly that is seen by the association as problematic.

The California State Assembly Committee on Labor and Employment recently held an informational hearing on the subject of workplace conditions in retail pharmacies. Among those testifying were pharmacists, academics, students, consumer advocates, and representatives of the California Retailers Association.

Orlando, Fla.--Pharmacists can collaborate with physicians and other health professionals in many ways, including through drug therapy management programs, pharmacy vaccine programs, and practice agreements, to build revenue streams and improve patient outcomes.

The National Community Pharmacists Association (NCPA) is still working to urge Congress to exempt community pharmacies from the Oct. 1 accreditation and surety bond requirements needed to continue providing durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) to Medicare patients.

On July 20, Steven C. Anderson, president and chief executive officer of the National Association of Chain Drug Stores (NACDS), sent a letter to political leaders regarding the America's Affordable Health Choices Act.

Congress gave the Food and Drug Administration (FDA) jurisdiction over tobacco in June, but don?t look for any quick changes in tobacco policy, products, or marketing. The agency is asking the public for guidance before jumping into regulation.

As of June 2009, it appears that North Carolina remains the only state to require any consistent public reporting of pharmacy-associated medication errors. In North Carolina, pharmacists must report errors associated with deaths.

Record budget problems have pushed California to eliminate funding for the largest poison control system in the nation. Keep reading to find out about a California pharmacy's fight to keep the poison control system going.

CVS, Merck, and Pfizer are just a few of the pharmaceutical heavyweights working together to electronically trace pharmaceutical products through the healthcare supply chain.

More than 80 community pharmacists from the National Community Pharmacists Association (NCPA) and several patients met with the Federal Trade Commission (FTC) May 13 to discuss concerns about the impact of the March 2007 CVS/Caremark merger and to urge the FTC to re-examine it.

Citizen petitions to the Food and Drug Administration (FDA) work. Sometimes.

The major message of the 2009 National Community Pharmacists Association's Annual Conference on National Legislation & Government Affairs was "get into politics, or get out of pharmacy."

The stimulus package passed in February has catapulted the field of comparative effectiveness research into a defining moment.

WellPoint's plan to sell its NextRx pharmacy benefits management unit to St. Louis-based Express Scripts is drawing criticism from independent pharmacists.

Pharmacist have many career options. Whether they're interested in politics, teaching, or travel, they can find fulfillment on and off the beaten path.

The New York Senate is considering a bill to permit qualifying seniors to obtain their prescription medications from a Canadian pharmacy group. New York pharmacists oppose any plan to take pharmacy dollars out of the state.

The former owner of a former pharmacy near Pittsburgh and one of his workers are charged with submitting $1 million in bogus prescription claims to Medicaid and private insurance companies.

The National Association of Chain Drug Stores (NACDS) is endorsing a congressional effort to crack down on the bulk sale of a cough syrup ingredient sometimes abused as a recreational drug.

With violence against pharmacists mounting across the country, the National Institute for Occupational Safety and Health (NIOSH) initiates a long-range study.

Widespread confusion about the new label format for prescription drugs has sent FDA officials to association meetings around the country, explanations in hand.

Now that pharmacists are empowered to vaccinate and immunize in every state but Maine, each state must work out regulatory requirements and protocols.