🏥HIPAA Modifications
This document updates compliance and other dates presented in the final rule that appeared in the December 13, 2024 Federal Register titled "Administrative Simplification: Modifications of Health Insurance Portability and Accountability Act of 1996 (HIPAA) National Council for Prescription Drug Programs (NCPDP) Retail Pharmacy Standards; and Modification of the Medicaid Pharmacy Subrogation Standard" to conform with the subsequent final rule that appeared in the February 11, 2025 Federal Register.
Learn More💊340B Program Notice
The U.S. Department of Health and Human Services (HHS) Health Resources and Service Administration (HRSA), Office of Pharmacy Affairs (OPA), which administers the 340B Drug Pricing Program (340B Program), is issuing this Notice to announce the availability of a 340B Rebate Model Pilot Program as a voluntary mechanism for qualifying drug manufacturers to effectuate the 340B ceiling price on select drugs to all covered entities, and to collect comments on the structure and application process of the 340B Rebate Model Pilot Program, as outlined in this Notice. OPA will consider comments received but is under no obligation to respond to or act on the comments. This Notice is effective immediately as published, unless revised by a future notice. OPA reserves the right to issue revisions or addenda to this Notice at a later date (including, but not limited to, revisions or addenda informed by public comment).
Learn More💊DEA Revokes Pharmacy Registration Due to Compliance Failures
The DEA issued an Order to Show Cause and revoked the registration of Just Here II Pharmacy, citing failures to maintain accurate records for dispensing controlled substances, which poses an imminent danger to public health. The decision emphasizes the importance of compliance with federal and state regulations governing the pharmaceutical industry.
Learn More💊Revocation of DEA Registration for JYA LLC - Major Implications
The Department of Justice has revoked the DEA registration of JYA LLC d/b/a Webb's Square Pharmacy due to serious violations, including dispensing controlled substances without legitimate prescriptions. The agency determined that these actions posed an imminent danger to public health, resulting in immediate sanctions and the denial of future registration applications. The ruling underscores the critical importance of compliance in pharmacy practice.
Learn More💊DEA Revokes Registration of Empire and Skyline Pharmacies for Violations
The Drug Enforcement Administration issued an Order to Show Cause and Immediate Suspension of Registrations to Empire Pharmacy Inc. and Skyline Pharmacy Inc. for alleged violations concerning recordkeeping and dispensing of controlled substances. The order indicates potential revocation of their registration, deeming their operations inconsistent with public safety and legal standards.
Learn More💊DEA Revocation of Mariste Pharmacy's Registration - Overview
The Drug Enforcement Administration (DEA) has issued a decision revoking Mariste Pharmacy's registration due to significant violations related to controlled substances. Allegations include failure to address red flags of abuse in prescriptions and inadequate record-keeping, raising concerns for regulatory compliance and public health. The decision emphasizes the importance of adherence to laws governing drug dispensing and security.
Learn More🚫Analysis of Baijes Bissonnet Pharmacy DEA Registration Denial
The Drug Enforcement Administration issued a denial notice to Baijes Bissonnet Pharmacy, highlighting significant compliance failures related to controlled substances. The notice outlines allegations of neglecting red flags indicating prescription abuse and diversion, leading to substantial legal risks and regulatory consequences for the pharmacy.
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