In this week’s issue, OSHA withdrew its emergency temporary standard (ETS), which required a mandatory vaccination policy for large private employers with an exception for employers that adopt a policy requiring mandatory...more
2/1/2022
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Centers for Disease Control and Prevention (CDC) ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Manufacturers ,
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Medical Supplies ,
Pharmaceutical Industry ,
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Public Health Emergency ,
Supply Chain ,
Vaccinations
Just before the New Year holiday, the FDA announced it that was suspending non-mission-critical domestic and foreign inspection activities. The FDA amended the EUA of the Moderna COVID-19 vaccine booster. The Center for Drug...more
Over the holidays, the CDC updated its recommendations for post-exposure quarantining and masking. The FDA authorized the Pfizer vaccine booster dose for adolescents 12–15 years of age and for immunocompromised children 5–11...more
In the past week, Pfizer and BioNTech announced they will request full approval from the FDA for the use of their COVID-19 vaccine in adolescents 12–15 years of age. They also plan to seek authorization of the booster dose in...more
In the past week, the FDA authorized the Pfizer and Moderna booster shots for all adult age groups, while the CDC Advisory Committee on Immunization Practices (ACIP) also recommended the Moderna vaccine booster for all...more
In the past week, the President has selected Dr. Robert Califf to be FDA commissioner. Congress passed the Infrastructure Investment and Jobs Act. New vaccination requirements were issued by OSHA and CMS for certain...more
In the past week, the FDA granted an EUA for the Pfizer-BioNTech vaccine for use in children 5–11 years of age. The agency also participated in the launch of the Bespoke Gene Therapy Consortium. The Administration held a...more
Last week, AstraZeneca and Merck filed emergency use authorization (EUA) requests for their COVID-19 drugs. The FDA provided information to the public about a database repository of gene variants and associated conditions....more
Last week, six U.S. agencies updated an advisory to urge businesses to conduct human rights due diligence for supply chain links to Xinjiang, China. In addition, the Pfizer/BioNTech COVID-19 vaccine received Priority Review...more
On August 21, 2019, EPA’s Final Management Standards for Hazardous Waste Pharmaceuticals takes effect federally. The sewer ban component of the new rule applies in all states....more
On December 12, 2018, the EPA released its long-awaited Management for Hazardous Waste Pharmaceuticals Rule. The EPA addressed industry concerns by amending the hazardous waste listing for nicotine to exclude nicotine...more
All entities selling drugs and sharps in California should be aware of California’s pharmaceutical and sharps waste stewardship bill, SB 212, which recently passed both houses of the state Legislature. ...more
On September 12, 2016, the U.S. Environmental Protection Agency (EPA) issued its Strategy for Addressing the Retail Sector under RCRA’s Regulatory Framework. As part of this strategy, EPA will finalize the Resource...more
All healthcare facilities, pharmaceutical reverse distributors and other hazardous waste generators should read the proposed rules, and each should analyze the impacts it will have on its operations and waste management...more
The Environmental Protection Agency (EPA) released its proposed Management Standards for Hazardous Waste Pharmaceuticals Rule. If finalized, it will create an entirely new subpart in the Resource Conservation and Recovery Act...more
Today, EPA released its proposed Management Standards for Hazardous Waste Pharmaceuticals Rule. The proposed rule, if finalized, will add a subpart P under 40 CFR part 266, which applies to the management of hazardous waste...more