NABP Pilot Brings Trading Partners, Regulators Together for Public Health Protection

Posted by in Boards of Pharmacy and NABP, State and Federal Regulatory Issues

Illustration of info sharing pathways between regulators and trading partners

By November 27, 2023, the Food and Drug Administration’s (FDA) Drug Supply Chain Security Act (DSCSA) will be fully implemented. We’ve been working with the boards of pharmacy, other regulators, and trading partners to prepare for the requirements included in Title II of the Act, which calls for product tracing at the package level.   Our […]

Read More ›

Bipartisan, Bicameral Bill Seeks to Address Illegal Drug Sales on the Dark Web

Posted by in Consumer Protection, State and Federal Regulatory Issues

Illustration of illegal drug sales and phishing scams on the internet

Congress has long had an interest in stemming the online sale of illegal opioids but investigating and identifying criminals who traffic these drugs on the dark web is incredibly challenging for law enforcement agencies. Enter the Dark Web Interdiction Act of 2022 (HR 7300, S 3782), a new bipartisan bill that seeks to improve the […]

Read More ›

Congress Prepares for the Next Phase of the Pandemic and Transformations in the Telehealth Industry 

Posted by in Pharmacies and Pharmacists, State and Federal Regulatory Issues

Illustration of regulating new pharmacy advancements

With the release of the White House’s next phase National COVID-19 Preparedness Plan and looming deadlines to fund the federal government, including replenishing aid for pandemic relief, it has been an eventful month on Capitol Hill for the health care industry. In the most recent iteration of President Joseph R. Biden’s pandemic preparedness plan, the White House […]

Read More ›

DEA Seeks Public Input as it Explores Regulating Telepharmacy 

Posted by in Pharmacies and Pharmacists, State and Federal Regulatory Issues

The coronavirus disease 2019 pandemic prompted state and federal government to shift guidance and relax policies on a wide range of telehealth services, which resulted in a boom in remote offerings for patients. However, long before this rapid transformation in telehealth, telepharmacy, an increasingly popular form of remote pharmacy care, has operated under a patchwork of state laws with […]

Read More ›

How e-Prescribing Trends Impacted the Opioid Epidemic

Posted by in Technology and Data Security, State and Federal Regulatory Issues

Image of Prescription on tablet

Before DEA published an interim final rule in 2010, which gave practitioners the option to write prescriptions for controlled substances (CS) electronically, e-prescribing for CS was prohibited in many states. Now, 11 years later, the regulatory and technological landscape has shifted significantly. As part of the larger effort to curb the opioid crisis, many states […]

Read More ›

Congress Holds Registries and Registrars Accountable for Rogue Online Pharmacies

Posted by in State and Federal Regulatory Issues

Graphic of secure shopping online

As has been reported extensively over the last several months, policymakers on both sides of the aisle have been unwavering in their pursuit to hold tech companies and social media platforms accountable for building a safer internet. Until recently, their focus has predominantly been on online platforms that serve as publishers of third-party content, such […]

Read More ›

Congress Takes Aim at Third-Party Platform Accountability for Counterfeits

Posted by in State and Federal Regulatory Issues

Graphic of Secure Shopping Online

After rampant sales of counterfeit masks, coronavirus disease 2019 (COVID-19) testing kits, medicines, and other goods over the past two years, there has been increased attention in Washington this holiday season on the health and safety risks of counterfeit products, particularly those sold online.   Just before Black Friday, the United States Chamber of Commerce and US Customs and Border Protection launched […]

Read More ›

DEA Takes Action Against Deadly Counterfeit Pills Sold Online

Posted by in Consumer Protection, State and Federal Regulatory Issues

Illustration of careful shopping for prescriptions

On September 27, 2021, for the first time in six years, Drug Enforcement Administration (DEA) issued a public safety alert warning Americans of a surge in deadly counterfeit pills containing fentanyl and methamphetamine flooding into the United States. The last time DEA issued a similar alert was to raise awareness of a national rise in […]

Read More ›

How Washington’s Response to Cyberattacks Impacts the Health Care Sector

Posted by in Consumer Protection, Technology and Data Security, State and Federal Regulatory Issues

Illustration of online security from cyber attacks

Cyberattacks targeting the nation’s critical infrastructure have become increasingly prevalent over the last few years, but, during the coronavirus disease 2019 (COVID-19) pandemic, attacks across all sectors have rapidly accelerated. Greater emphasis on remote work and business operations have created the “perfect storm” for cybercriminals to exploit security flaws within many organizations, especially the health […]

Read More ›

Truths and Misconceptions About FDA’s Compounding MOU

Posted by in Boards of Pharmacy and NABP, Pharmacies and Pharmacists, State and Federal Regulatory Issues

Graphic showing people collaborating

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 ›
Page 1 of 3
1 2 3