Insights & Analysis
Practical guidance on PBM audits, federal investigations, compounding defense, DEA enforcement, telehealth compliance, and the regulatory pressures facing pharmacies and providers nationwide.
More articles — Page 27
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Records to Have Ready for an FDA Inspection of a 503A Pharmacy
A records readiness checklist for 503A pharmacies: the prescription, formulation, distribution, complaint, and supplier files FDA…
Stark Law Exceptions Physician Practices Rely On
Stark Law exceptions make routine physician financial relationships lawful, but liability does not require intent, so paperwork ga…
Nursing Facility Medicaid Audits: MDS Reviews and Cost Reports
How state Medicaid agencies review nursing facility MDS assessments, cost reports and resident trust funds, and what follows a rec…
PBM Annual Attestations and FWA Training: Signing Accurately
Network pharmacies sign a yearly PBM attestation on FWA training, exclusion screening, and policies. An inaccurate signature creat…
Sending Expired Controlled Substances to a Reverse Distributor
A pharmacy checklist for confirming a reverse distributor's DEA registration, the Form 222 and recordkeeping rules by schedule, an…
Master Formulation Records and Compounding Records Under Inspection
What a master formulation record and a compounding record must contain, who has to sign off, and the documentation gaps inspectors…
Types of Pharmacy Audits and Who Runs Each One
PBM, Medicare Part D, state Medicaid, DEA, board of pharmacy, and manufacturer REMS audits each run on a different authority and r…
Labeling Compounded Drugs: What FDA and Board Inspectors Check
A compounded drug's label must show required content, a compounded statement, and a beyond-use date, which differ between 503A and…
CVS Caremark Pharmacy Audits: A Preparation Checklist
A checklist for the window between a CVS Caremark audit notice and the document due date, drawn from the current Caremark Provider…