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OTC Switch Behind the Counter: Federal Status and Access Rules
OTC Switch Behind the Counter describes a medication that has moved from prescription-only to nonprescription (OTC) status through FDA review, yet is kept behind the…
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Orange Book Therapeutic Equivalence: A Ratings and Substitution Guide
Orange Book Therapeutic Equivalence Basics The Orange Book Therapeutic Equivalence ratings are FDA-assigned codes in Approved Drug Products with Therapeutic Equivalence Evaluations. They help determine…
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REMS: Risk Evaluation and Mitigation Strategies Compliance
Risk Evaluation and Mitigation Strategies (REMS) is an FDA-required safety program used when a medicine’s serious risks need extra controls beyond standard labeling. You’ll see…
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FDA Recalls Class I-II-III: Pharmacy Technician Recall Classification Guide
FDA Recalls Class I-II-III are FDA-assigned risk categories for firm-initiated removals or corrections of marketed drugs and devices. They tell you how urgently to act…
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HIPAA Privacy in the Pharmacy: Protecting PHI at the Counter
HIPAA Privacy in the Pharmacy is the set of federal privacy and security safeguards that control how your pharmacy uses, discloses, and protects protected health…
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Transfer Rules for Controlled Prescriptions: DEA One-Time Transfer Rules and Documentation
Transfer Rules for Controlled Prescriptions are the federal and state requirements that govern moving a controlled-substance prescription from one pharmacy to another. Think of them…
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Emergency Schedule II Phone Order: DEA Emergency Oral Prescription Rules
An Emergency Schedule II Phone Order is the narrow DEA exception that lets a pharmacist take an oral prescription for a C-II drug when immediate…
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Partial Fill of Schedule II: DEA Rules for CII Prescriptions
What Is a Partial Fill of Schedule II? Partial Fill of Schedule II means dispensing less than the full quantity written on a Schedule II…
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DEA Form 106: Controlled Substance Theft Reporting Essentials
DEA Form 106 is the DEA’s “Report of Theft or Loss of Controlled Substances.” It is the formal record you use when a pharmacy discovers…
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DEA Form 41 Destruction: Documentation for Controlled Substance Disposal
If your pharmacy destroys expired or unusable controlled substances, DEA Form 41 Destruction is the record that proves it happened by the rules. It is…