Legal News

Executives with the American Society of Health-System Pharmacists and other groups are urging Congress to pass federal legislation to ease drug shortages in the United States.

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.

After much legal wrangling, pharmacies in San Francisco can no longer carry cigarettes.

An OIG audit concluded that CMS is paying pharmacies for dispensing terminated drugs under Medicare Part D, while CMS insists it is not.

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.

Counterfeit medications and substandard medications are on the rise, according to Interchange 2010, a conference sponsored by the Partnership for Safe Medicines.

At the Third Annual Risk Management and Drug Safety Summit, attendees and presenters discussed the latest issues related to risk and safety, and examined how REMS and drug safety have fared since 2007.

Pharmacists speak out about the pros and cons of the placebo effect.

A question was posed to students of a pharmacy ethics class. In every case, the answers given by the students were different from the responses of the practicing pharmacists.

The Office of the Inspector General found that CMS reimbursed plan sponsors $43.3 million for prescription drugs on the market that FDA classifies as less than effective.

As the nation rolls out the new healthcare reform law, the National Association of Chain Drug Stores is urging more recognition for the role of pharmacists in medication adherence.

FDA has determined to significantly restrict the use of formulations that contain rosiglitazone (Avandia, Avandamet, and Avandaryl, GlaxoSmithKline) to patients with Type 2 diabetes who cannot control their diabetes with other medications.

Pharmacies soon may be stocking their shelves with laboratory-developed tests that first require FDA approval.

Abbott is complying with FDA's request to withdraw sibutramine (Meridia) from the U.S. market because the obesity drug may pose unnecessary cardiovascular (CV) risks to patients.

The DEA has changed its policy and now recognizes long-term-care nurses as agents of prescribers of Schedule C-III through C-V medications, according to a Federal Register notice released today.

Underlying a recent FDA-hosted public meeting and workshop was the question of how FDA as a regulatory agency should increase its current oversight of clinical laboratories, specifically those developing genetic tests that may be offered at their own facilities or made available through direct-to-consumer channels.

Thirty-nine states now have a tool to help pharmacists identify at least some questionable prescriptions and suggest when a patient may be doctor-shopping or pharmacy-shopping in order to obtain controlled substances. That tool is the state prescription monitoring program.

FDA advisory committee members voted 25 to 10 to reject a proposed plan to establish a risk evaluation and mitigation strategy for extended-release and long-acting opioid analgesics during the joint meeting on July 23 of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee in Adelphi, Md.

A Congressional bill aims to boost the capacity for information exchange among state programs that monitor prescription controlled substances and seeks to provide continued grant funding to support such efforts.

Collaborative practice agreements between physicians and pharmacists will be a reality in Pennsylvania within the next couple of years.

The Washington State Board of Pharmacy is revisiting its rules requiring pharmacists to dispense emergency contraceptives.

Use of bar-code technology is widespread in the general retail environment. Its advantages have not yet been fully exploited in the hospital and community-pharmacy settings.

The 2,400-page healthcare reform bill included language establishing the Patient Centered Outcomes Research Institute, a group grounded in the tenets of comparative effectiveness research. Its mission is significant, but whether it has the power to effect change remains to be seen.

Although the Patient Protection and Affordable Care Act (PPACA) creates an abbreviated approval pathway for biological products that are demonstrated to be ?highly similar? (biosimilar) to or ?interchangeable? with an FDA-approved biological product, only time will tell how long it will take for these biosimilars to reach the marketplace.

Sens. Kay R. Hagan (D-N.C.) and Al Franken (D-Minn.) have introduced The Medication Therapy Management (MTM) Expanded Benefits Act, a bill that will allow seniors with one chronic illness to thoroughly review all their medications with a pharmacist in a one-on-one session.

The Drug Enforcement Administration has released its long-awaited interim final rule for electronic prescribing of controlled substances.

A ballot initiative moving toward approval in North Dakota could open the doors to chain pharmacy in the state.

The relationship between prescribing practitioners and nurses working in a long-term-care (LTC) facility is of significant concern to the LTC facility when controlled substances are needed.

As Americans increasingly turn to vitamins and herbal supplements as alternatives to prescription drug use, medical professionals and government leaders worry that few realize the implications.

Oregon's law requiring prescriptions for pseudoephedrine products practically eliminated its illicit methamphetamine problem. But some pharmacists, consumer groups, and the drug industry say that it will increase healthcare costs and inconvenience consumers. They think electronic sales-tracking systems would be a better approach.