Legal News

Frustrated by its lack of success at reining in drug-company abuses, FDA is bringing back a legal doctrine spawned by long-dead rodents to bring criminal charges against pharmaceutical executives, including executives who had no personal knowledge of company misdeeds.

A recent state appellate court decision in California could help pharmacists claim meal and rest breaks they are due under state labor law. The case, which involved United Parcel Service workers, affirmed workers' right to up to 2 hours of extra pay daily.

With the expansion of pharmacist roles come the burdens of managing the existing obligations embedded in professional pharmacy practice. Technicians, when appropriately trained and certified, can help fulfill many delegated functions in the pharmacy.

FDA recently called for the addition of new Risk Evaluation and Mitigation Strategy requirements for medications. This article examines some resulting challenges and potential solutions.

CMS has eased rules on short-cycle dispensing of Part D medications in long-term-care facilities and is now requiring not 7-day but 14-day fills. The workload, however, may still double or triple.

We do not usually think of courage as a part of a pharmacist's ethical duties, but it is, and it is one that is sometimes the most difficult to practice.

DEA's "Office of Diversion Control" prevents, detects, and investigates the diversion of controlled substances from legitimate sources while ensuring an adequate and uninterrupted supply for legitimate medical needs. To accomplish this mission, the DEA sets forth regulations designed to prevent any such diversion.

Both the Food and Drug Administration and officials from a number of generic drug companies indicate they are in active talks on creating user fees to be paid by that industry to give the agency more resources to speed generics to the market, carry out inspections and other functions.

Very few state laws require a pharmacy to use a drug container that meets minimum quality-control standards. Legal metrics are needed to guard against possible patient harm resulting from an adulterated drug product caused by a "bad" container.

NACDS has filed a brief in support of an Orlando hospital fighting a Department of Labor ruling.

There are 2 measures of success every pharmacy should post on its wall. The first indicates percentage of QREs (quality-related events) in prescription fills, and the second measures the percentage of QREs caught before they reach the patient.

Telepharmacy is still a novelty, and there is a lag in implementation of new laws after professional and technological innovations are deployed.

Controlling the expensive price tag of Medicare is an ongoing concern of both the Obama administration and Congress. Therefore, any Medicare provider can expect an audit. Is your pharmacy prepared?

NACDS is urging Congress to make several federal regulations economically viable for retail community pharmacists.

Despite the electronic-tracking systems for pseudoephedrine that have been implemented in several states, methamphetamine-related activity is on the rise.

New draft standards from the U.S. Pharmacopeial Convention could bring dramatic changes to Rx labels as early as 2012. Changes to USP Chapter 17, Prescription Container Labeling, include larger font, placement of the most important information at the top, more understandable language, and more white space.

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.