Author: Peter

DYNALABS, in St. Louis, Missouri, announced the new policy after Reuters published an investigation...that named some of the companies involved in a secret supply chain to make and test a drug ahead of the first federal executions in 17 years...DYNALABS, told Reuters they did not know the samples of the drug, pentobarbital, belonged to the Justice Department, nor that it was intended for executions...“It will be our policy going forward to require a statement from our client indicating their preparation will not be used for execution,” Michael Pruett and Russell Odegard, DYNALABS’ co-founders, said in a statement published on Friday on their website. “Clients that decline to make that declaration will not be allowed to submit their pentobarbital preparations to DYNALABS for testing.”...READ MORE

USP has announced the release of six new Reference Standards to support manufacturers and regulators in analyzing and monitoring potentially harmful nitrosamine impurities in the drug supply chain...in 2018, nitrosamine impurities were found to be present in some angiotensin II receptor blockers used to treat high blood pressure and heart failure...exposure to this class of chemical compounds, nitrosamines have the potential to cause cancer. Nitrosamine impurities have since been found in ranitidine and metformin, leading to major recalls and efforts by regulators and industry worldwide to reduce or eliminate the presence of these impurities in the drug supply...READ MORE

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

New technology to disinfect N95 masks worn by health care workers is now in Nevada, but a major nurses union is questioning the effectiveness of the process...The Battelle Critical Care Decontamination System has been used to clean more than 1,700 of the N95 masks since early May. It uses vaporized hydrogen peroxide to kill the novel coronavirus, which causes the respiratory disease COVID-19...The new sanitization process is intended to make that equipment last even longer if necessary...Battelle says the system can clean a mask for up to 20 reuses, but National Nurses United, the country’s largest union of registered nurses, has repeatedly called for the process to be halted immediately...Union president Zenei Cortez wrote in a statement that union members reported their decontaminated masks came back deformed and their straps had lost elasticity. The masks’ ability to filter out dangerous particles depends on their snug facial fit...Similar concerns were also raised by a local hospital worker and member of the Nevada chapter of Service Employees International Union...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

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

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