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EXCPT Pharmacy Laws & Regulations 2025/2026 – 60+ Verified Q&A | DEA Forms, REMS, Federal Acts, Recalls, HIPAA, FDA & Controlled Substance Rules

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This expertly designed study document includes 60+ verified and updated exam questions with answers for the EXCPT (Exam for the Certification of Pharmacy Technicians) 2025/2026, focused entirely on pharmacy laws, federal regulations, and controlled substance protocols. Aligned with NHA guidelines, it provides a deep-dive into key legal frameworks, safety standards, and compliance measures every certified pharmacy technician must master. Students will gain clarity on landmark legislation, drug scheduling rules, regulatory programs, and legal definitions that directly impact pharmacy operations and patient safety in the U.S. Topics Include: DEA Regulations & Forms: Full breakdown of DEA Forms 222, 106, 224, 225, 363, and 41, including use-cases and renewal timelines Federal Acts & Legislative History: Pure Food & Drug Act (1906), Durham-Humphrey Amendment, FDCA, Harrison Narcotic Act, Kefauver-Harris Amendment, HIPAA, OBRA ‘90, and the Drug Addiction Treatment Act Safety & Risk Management: REMS programs for Isotretinoin (iPledge), Clozapine (Clozaril Registry), and Thalidomide; MedWatch adverse reaction reporting Controlled Substance Schedules & Transfers: DEA scheduling system (C-I to C-V), labeling requirements, addiction risk, and legal transfer rules Drug Recalls: Differentiation of Class I, II, and III recalls and related health risk levels Packaging, Labeling & Consumer Protections: Poison Prevention Packaging Act, tamper-evident packaging, FDA labeling enforcement, child-resistant requirements Modern Healthcare Laws: Affordable Care Act (ACA), Combat Methamphetamine Epidemic Act (2005), Medicare Modernization Act, and more ‍⚕️ Best for: Pharmacy technician students preparing for the legal portion of the EXCPT Healthcare compliance trainees and instructors needing accurate legal reference content Pharmacology, medical assisting, and health science students preparing for regulated roles Pharmacy preceptors, tutors, and training providers in need of exam-focused law content Career changers entering regulated healthcare environments With a strong emphasis on lawful practice, patient safety, and DEA compliance, this guide helps candidates not only pass the exam but also uphold the responsibilities of a licensed pharmacy technician with confidence and integrity. Keywords: EXCPT 2025, pharmacy laws, DEA Form 222, Form 106, HIPAA, FDA, REMS, iPledge, Clozapine registry, OBRA 90, Harrison Narcotic Act, Controlled Substances Act, Durham-Humphrey, drug recalls, Class I recall, Medicare Modernization Act, isotretinoin, thalidomide, poison prevention, MedWatch, anabolic steroids, tamper-evident, pharmacist counseling, federal drug laws, combat methamphetamine act

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EXCPT Pharmacy Laws and Regulations
2025/2026 Exam Questions and Correct
Answers | New Update



Pure Food and Drug Act of 1906 - 🧠 ANSWER ✔✔Prohibits interstate

transportation or sale of adulterated or misbranded food and drugs


Occupational Safety and Health Act of 1970 (OSHA) - 🧠 ANSWER ✔✔To

assure safe and healthful working conditions for working men and women


Durham-Humphrey Amendment - 🧠 ANSWER ✔✔Requires the label

"caution: federal law prohibits dispensing without prescription"

Made distinction between legend and no legend drugs


Food, Drug & Cosmetic Act - 🧠 ANSWER ✔✔Legalized the FDA

, Required all controlled substances to be labeled with "Warning: may be

habit forming" and prohibited misbranding


Harrison Narcotic Act - 🧠 ANSWER ✔✔Prevented the sale of opium without

a prescription


Kefauver-Harris Amendment - 🧠 ANSWER ✔✔Attempts to ensure the

safety and effectiveness of all new drugs


Poison Prevention Package Act - 🧠 ANSWER ✔✔Requires childproof caps


Orphan Drug Act - 🧠 ANSWER ✔✔Allowed some


Companies to bypass some time requirements and costs of testing a new

drug for orphan diseases

Comprehension Drug Abuse Prevention & Control Act - 🧠 ANSWER

✔✔DEA formed


Control drugs can be addictive and are placed in one of 5 categories


Omnibus Budget Reconciliation Act - 🧠 ANSWER ✔✔Pharmacist must offer

to counsel all patients who receive new drugs
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