Truths and Misconceptions About FDA’s Compounding MOU
Earlier this month, FDA announced it will provide states one more year to decide whether to sign its compounding memorandum of understanding (MOU) before the agency begins enforcing the statutory 5% limit on out-of-state distribution of compounded human drug products. This comes after many states asked for more time to wrangle with the legal and […]
Read More ›The Future of Telehealth and the Ryan Haight Act Post-Pandemic
A year into the pandemic, and coronavirus disease 2019 (COVID-19) has radically changed our health care system from the pace at which new drugs come to market to how patients access health care and medications. Arguably one of the most dramatic shifts has been the major increase in telehealth usage and the expansion of services […]
Read More ›NABP, FDA Collaborate to Improve Compounding Pharmacy Oversight
In 2012, many of the people who received contaminated steroid injections produced at the New England Compounding Center had already been suffering from chronic pain. The compounded drugs were supposed to provide relief. Instead, they infected these patients with fungal meningitis, killing 64 and sickening 753. The tragedy was a wakeup call for regulators, […]
Read More ›Access to Treatment for Opioid Use Disorder Is Limited by Unnecessary Regulations
Across the country, officials are reporting spikes in drug overdoses as the opioid epidemic is exacerbated by the COVID-19 pandemic. The Centers for Disease Control and Prevention recently reported the highest number of overdose deaths ever recorded in a 12-month period – 81,000 people. Access to opioid use disorder treatment could help save the lives […]
Read More ›Why the White Pages of the Internet Matters to Public Health
This week, members of the Coalition for a Secure and Transparent Internet (CSTI) – including NABP – will virtually take to Capitol Hill to meet with members of Congress to discuss restoring access to WHOIS data. NABP and other CSTI members will speak with congressional staff about how essential this data is to law enforcement […]
Read More ›Countdown Clock Begins on Importation Rule Enactment
Following an expeditious review by the White House Office of Management and Budget, Food and Drug Administration (FDA) formally published its final rule regarding Importation of Prescription Drugs in the Federal Register on Thursday, October 1, 2020. The publication of the final rule starts the 60-day formal notice-and-comment period before the rule becomes effective on Monday, November 30. The […]
Read More ›White House Completes Review of Importation Final Rule
On Thursday, September 10, Food and Drug Administration (FDA) sent a proposed final rule to the White House Office of Management and Budget (OMB) for review that would set in motion components of the long-awaited Safe Importation Action Plan released in July 2019. Completion of this final rule has been a long-standing priority for FDA and the […]
Read More ›Online Platform Scrutiny Continues as Congress Reviews Section 230
As has been reported extensively over the last several months, the coronavirus disease 2019 (COVID-19) pandemic has presented an opportunity for criminals to leverage international fear and uncertainty for profit. Even predating the declaration of a national health emergency by the Trump Administration in March 2020, the United States Food and Drug Administration (FDA) and […]
Read More ›Pharmacy Community Pulls Together To Combat COVID-19
Challenging government and civil society at all levels, the COVID-19 pandemic has tested the ability of public officials, local and federal agencies, health care entities, and numerous other stakeholders to act quickly and effectively in a public health crisis. Because pharmacists play such an important role as frontline and accessible health care providers, numerous organizations […]
Read More ›How Washington’s Response to COVID-19 Impacts Pharmacy Practice
As the nation and the world contended with the emergence and spread of COVID-19 this spring, policymakers in Washington responded with unprecedented speed by enacting and implementing multiple sweeping laws and regulations to combat the virus. From major cash assistance for businesses and individuals to sweeping healthcare reforms, the COVID-19 public health emergency drove policies […]
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