Legal News

The Independent Specialty Pharmacy Coalition, a group of community-based specialty pharmacies, called on the Federal Trade Commission to block Express Scripts? proposed acquisition of Medco.

As a result of combined investigations by FDA, the IRS Criminal Division, and the U.S. Department of Justice, Elisane Garcia was sentenced on July 25 for disguising controlled substances as "Brazilian diet pills" and smuggling them into the United States with intent to distribute. She was also convicted of 1 count of money-laundering.

If the U.S. Congress fails to reach a consensus on the deficit issue by August 2, there could be significant impact on Medicare and other federal programs, the National Association of Chain Drug Stores announced today.

Opponents of a controversial Change Request initiated by the Centers for Medicare and Medicaid Services aired their views to CMS officials earlier this week.

The National Community Pharmacists Association expects U.S. legislators to get behind 2 new bills that would allow independent pharmacists to negotiate insurance contracts with pharmacy benefit managers.

Founded in 1904, the National Association of Boards of Pharmacy is an impartial professional organization geared toward supporting the efforts of individual state boards of pharmacy to protect the public health and safety.

As expected, the U.S. Supreme Court recently struck down a landmark case that would have prohibited data-mining companies from selling physicians' prescribing information to pharmaceutical manufacturers for use in marketing. Still some independent pharmacists say they are not in favor of the practice.

One component of a new federal action plan for controlling viral hepatitis calls for expanded delivery of hepatitis A and B vaccines through pharmacies, beginning in 2013.

Whereas historic pharmacy practice linked the pharmacist to a product, as pharmacists move toward more complete healthcare services, they are now also providers of cognitive services. As pharmacists delve further into cognitive services and take on greater patient responsibility, the process is likely to add to liability exposure.

The Food and Drug Administration and Federal Trade Commission are cracking down on fraudulent dietary supplements claiming to treat sexually transmitted diseases.

As pharmacists responsibilities expand, so may some of their liabilities. A number of those liabilities may be related to controlled substances.

Pharmacists are often reluctant to apologize. One fear is that lawyers may use their statements against them. Another fear is that they may be violating their own malpractice insurance policies. But there can be advantages to saying, "I made a mistake; I am sorry." A patient may be saved and a possibly explosive situation may be cooled. For most of us, it is the natural thing to do.

Are pharmacies subcontractors when they fill prescriptions for TRICARE, the federal health program for military personnel? Not according to the National Association of Chain Drugs Stores.

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.

In the White House Budget, President Barack Obama targets the high cost of prescription drugs and proposes 2 significant changes for improving consumer access to less-expensive generic drugs.

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.