DEA Issues Final Rule Outlining Regulatory Provisions for EMS Handling CS
Drug Enforcement Administration (DEA) has published a final rule that implements requirements related to registering emergency medical services (EMS) agencies under the Protecting Patient Access to Emergency Medications Act of 2017. The final rule harmonizes DEA regulations to the statutory language describing the security, storage, record keeping, and administration requirements for EMS agencies handling controlled […]
Read More ›New iPLEDGE REMS Modifications to Be Implemented in August 2026
New modifications are expected to be implemented to the iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) to reduce burdens for pharmacists, patients, and prescribers while ensuring the safe use of isotretinoin. Food and Drug Administration notes that if permitted by the prescriber, patients will be allowed to complete pregnancy testing outside of a medical setting […]
Read More ›CDC Recommends ‘Individual-Based Decision-Making’ Approach for Hepatitis B Vaccines in Children
The Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices is recommending “individual-based decision making” for its hepatitis B vaccination in children. The individual-based decision-making approach means that patients are recommended to consult a health care professional to discuss the benefits and risks of hepatitis B vaccination. Additionally, CDC advises that parents […]
Read More ›Dr. Lorna Breen Health Care Provider Protection Reauthorization Act Signed Into Law
On February 3, 2026, the Dr. Lorna Breen Health Care Provider Protection Reauthorization Act, which supports providing health care practitioners access to mental health and well-being programs through September 2030, was signed into law. Under this reauthorization act, programs can continue developing strategies for reducing and preventing suicide, burnout, and mental and behavioral health conditions […]
Read More ›CMS Allocates Funding for Rural Health Transformation Program
Centers for Medicare & Medicaid Services (CMS) recently announced the allocation of funds to all 50 states as part of the Rural Health Transformation Program. These funds are part of an initiative aimed at improving access to health care in rural communities. Through the program, states are expected to invest in increasing preventive, primary, maternal, […]
Read More ›SUPPORT for Patients and Communities Reauthorization Act of 2025 Signed Into Law
The SUPPORT for Patients and Communities Reauthorization Act of 2025 was signed into law. This legislation renews funding for programs that address the prevention of, treatment for, and recovery from substance use disorder and mental health conditions. Additionally, the bill expands support resources for first responders and employment services for people in recovery, as well […]
Read More ›HHS Issues Final Rule Updating Retail Pharmacy Standards for Electronic Transactions Under HIPAA
The United States Department of Health and Human Services (HHS) will publish the final rule regarding updated retail pharmacy standards for electronic transactions adopted under the Administrative Simplification subtitle of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Specifically, the retail pharmacy transaction standards for health care claims or equivalent encounter information, eligibility […]
Read More ›CMS Issues Final Rule to Adopt NCPDP SCRIPT Standard Version 2023011
Centers for Medicare & Medicaid Services (CMS) has issued a final rule for health information technology standards to adopt the National Council for Prescription Drug Programs (NCPDP) SCRIPT Standard Version 2023011. The updated SCRIPT Standard Version will allow electronic controlled substance prescription transfers between pharmacies. The transition period from NCPDP SCRIPT Standard Version 2017071 to […]
Read More ›FDA Grants Small Dispensers Exemptions From Certain DSCSA-Related Requirements of FD&C Act
Food and Drug Administration (FDA) has granted small dispensers (pharmacies) and, where applicable, their trading partners an exemption from certain requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) until November 27, 2026. With this exemption, small dispensers will have more time to stabilize their operations to completely implement the […]
Read More ›FDA Delays Enforcement of Certain DSCSA Requirements Until November 2024
Food and Drug Administration (FDA) has published final guidance delaying enforcement of certain Drug Supply Chain Security Act (DSCSA) requirements until November 27, 2024. The extension will give trading partners (drug and device manufacturers, wholesale distributors, dispensers, and repackagers) additional time to further “develop and refine appropriate systems and processes to conduct interoperable, electronic tracing […]
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