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Declining to Fill a Prescription

New CS Theft or Loss Reporting Form

Meal Periods and Break Periods

National Pharmacy Compliance News

FDA Releases MOU on Human Drug Compounding Regulation and Oversight

FDA Clarifies Compounding Rules, Offers Flexibility to Help Ease Drug Shortages During COVID-19 Pandemic

FDA Issues Updated Guidance for Compounding Pharmacies Experiencing PPE Shortages

HHS Expands Telehealth Access in Response to COVID-19

Criminals Found Posing as CDC Representatives to Steal Money and Information

State officials presented to the Senate...$233 million in proposed cuts from the health care budget that will slash key programs for low-income Nevadans and significantly pare back mental health services to ease a budget crisis caused by the ongoing coronavirus pandemic...Many of the proposed cuts will roll back initiatives spearheaded by lawmakers and the Department of Health and Human Services over the last few legislative sessions in an effort to improve health care in the state, which ranks among the worst in the nation...The recommended reductions to the Department of Health and Human Services budget will, if approved, make up nearly 20 percent of the $1.2 billion shortfall projected by the governor’s office and more than 42 percent of the proposed $549 million in agency rate reductions...READ MORE

A group of pharmacies and pharmacy organizations urged the Centers for Medicare & Medicaid Services to formally recognize and promote medical at home pharmacy services for long-term care —particularly in the wake of the coronavirus disease 2019 (COVID-19) pandemic...“With medical at home pharmacy services being needed now more than ever due to the coronavirus public health emergency, long-term care pharmacy stakeholders are urging the Centers for Medicare & Medicaid Services to formally recognize and promote these services to help improve value-based patient care, increase savings, and ensure pharmacy providers are fairly and properly reimbursed,”...READ MORE

Accused of favoring profits over patients’ lives, French pharmaceutical company Servier Laboratories is facing millions of euros in potential fines and damages after a huge trial involving 6,500 plaintiffs who say the company allowed a diabetes drug to be widely and irresponsibly prescribed as a diet pill — with deadly consequences...The popular drug, called Mediator, became one of France’s biggest modern health scandals, and the trial is wrapping up Monday after more than six months of proceedings targeting both Servier and France’s medicines watchdog. Servier says it didn’t know about the drug’s risks...Servier is accused of manslaughter, involuntary injury, fraud, influence trading and other charges. Investigating magistrates concluded that Servier for decades covered up Mediator’s effects on patients. The national medicines agency is suspected of colluding in masking its dangers...READ MORE

Leaders of a rural Nevada church are asking the U.S. Supreme Court to suspend the state’s 50-person cap on religious gatherings while an appellate court considers their claim that COVID-19 restrictions treating casinos and others more leniently violate their constitutional right to freely exercise their beliefs...Gov. Steve Sisolak’s June 4 directive allowing casinos, restaurants, bowling alleys and amusement parks to reopen at 50% of capacity while maintaining a hard cap for church services “simply turns the First Amendment on its head,” lawyers for Calvary Chapel Dayton Valley wrote in the request to the high court for an emergency injunction...“The Free Exercise Clause protects the exercise of religion. No constitutional provision protects the right to gamble at casinos, eat at restaurants, or frolic at indoor amusement parks,” they said...READ MORE

A U.S. judge, skeptical of how Bayer plans to resolve future Roundup claims, says he's "tentatively inclined" to reject that part of the $10 billion-plus settlement...Looks like Bayer’s Roundup litigation headache may not be over after all, even after the company committed nearly $11 billion to a settlement...U.S. District Judge Vince Chhabria...said in a court filing...that he’s ready to reject part of the deal centered on potential future claims that the popular Monsanto weedkiller causes cancer...“[T]he Court is skeptical of the propriety and fairness of the proposed settlement, and is tentatively inclined to deny the motion,” Chhabria wrote...READ MORE

The Trump administration has formally notified the United Nations of its withdrawal from the World Health Organization, although the pullout won’t take effect until next year, meaning it could be rescinded under a new administration or if circumstances change...The withdrawal notification makes good on President Donald Trump’s vow in late May to terminate U.S. participation in the WHO, which he has harshly criticized for its response to the coronavirus pandemic and accused of bowing to Chinese influence...The move was immediately assailed by health officials and critics of the administration, including numerous Democrats who said it would cost the U.S. influence in the global arena...READ MORE

To eradicate SARS-CoV-2, the virus that causes COVID-19 illness, we'll need a vaccine that's 70% effective—and 70% of the population will need to receive it, an FDA vaccine official said...That's a higher bar than the FDA set last week. To pass muster at the agency, a COVID-19 vaccine will need to be at least 50% more effective than placebo, according to new FDA guidelines...But the agency felt a 50% efficacy requirement was a “reasonable place” and about comparable to a flu vaccine on a good year, said Peter Marks, director of the Center for Biologics Evaluation and Research...READ MORE

Nearly one in five diabetes drugs and one in 20 asthma drugs experienced a significant price increase in the past year or two, with average one-year increases about 11.2 percent and 19.3 percent, respectively, according to the third annual drug pricing report released by the Nevada Department of Health and Human Services last week...The state identified 117 essential diabetes drugs and 13 essential asthma medications that had a significant price increase over the previous one or two years, meaning that their costs increased by more than the rate of medical inflation. Manufacturers attributed the price increases to a number of factors, including changes in marketplace dynamics, research and development and manufacturing cost...the findings of the report continued to be consistent with the results of the first two diabetes drug pricing reports...Here are some of the key findings of the report:...READ MORE

The FDA called for five drugmakers to voluntarily withdraw their metformin products in May...Diabetes med metformin has been in the FDA's crosshairs since the agency found high levels of a probable carcinogen, NDMA...an Indian drugmaker will expand its own metformin recall after confirming the FDA's testing...Lupin Pharmaceuticals has pulled all lots of metformin after discovering unacceptably high levels of a probable carcinogen, N-Nitrosodimethylamine (NDMA), in tested samples...READ MORE