FDA Advertising Rules: Can You Legally Advertise Compounded Drugs? The “Off-Label” Promotion Rules That Can Cost You Millions.
Compounded drugs fill real gaps in care. But the moment you promote them, you step into a thicket … Read more
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Adulteration vs. Misbranding: The Two FDA Violations That Can Shut You Down, Why Dropping a Pill on the Floor Is a Federal Crime.
Two short words do most of the heavy lifting in FDA law: adulteration and misbranding. They sound technical. … Read more
Medicare Part D Audits: They Aren’t Just Checking Prescriptions, The Top 5 Clerical Errors That Lead to Massive Clawbacks.
Medicare Part D audits do not just verify that a drug was clinically appropriate. They examine whether the … Read more
Stark Law for Pharmacists: How Providing “Free” Services Can Be an Illegal Kickback, The Hidden Trap in Patient Care.
Pharmacists often add “free” services to improve patient care—delivery, blister packs, prior authorization help, ride vouchers, loyalty points. … Read more
The Anti-Kickback Statute: Why That “Free Lunch” from a Sales Rep Is a Federal Crime, The Line Between Marketing and a Bribe.
A drug or device rep offers to cater lunch for your office and give a quick product talk. … Read more
Fraud, Waste, and Abuse (FWA): The Annual Training You Click Through Could Cost You Your Job, What FWA Actually Means in a Pharmacy.
You probably click through your annual Fraud, Waste, and Abuse (FWA) training between rushes. In pharmacy, that habit … Read more
PDMP (Prescription Drug Monitoring Program): You Are Legally Required to Check the Database, But When? The State-by-State Rules You Must Know.
Most states now require clinicians to check their Prescription Drug Monitoring Program (PDMP) before writing certain controlled-substance prescriptions. … Read more
“Corresponding Responsibility”: Why You Can Be Jailed for a Doctor’s Bad Prescription, The Legal Shield You Must Use to Protect Your License.
Pharmacists often assume the prescriber carries all the legal risk for a bad controlled-substance prescription. That is wrong. … Read more
DEA Form 106 (Theft/Loss): You Have 24 Hours to Report “Significant Loss,” But What Is “Significant”? The Vague Rule That Trips Up Pharmacists.
Pharmacies have to tell the DEA fast when controlled substances go missing. The rule says you must notify … Read more
DEA Form 41 (Disposal): The Legal Nightmare of Wasting Controlled Substances, Your Iron-Clad Duty to Document Destruction.
Destroying controlled substances is never just a housekeeping task. The law treats destruction as a high-risk moment for … Read more