Pharmacy Law Deep Dive
Pharmacy law encompasses federal and state statutes, regulations, and rules that govern pharmacy practice. Pharmacy technicians must understand the major federal laws and the concept that when state and federal laws conflict, the stricter standard applies. This guide covers the laws most commonly tested on the CPHT exam.
Key Federal Laws
Pure Food and Drug Act (1906)
The first major federal law addressing drug safety. It prohibited the manufacture and sale of adulterated or misbranded drugs and food. This law laid the groundwork for the FDA.
Federal Food, Drug, and Cosmetic Act (FDCA) (1938)
Enacted after the sulfanilamide disaster (a toxic solvent killed over 100 people), the FDCA:
- Required drugs to be proven safe before marketing (pre-market approval).
- Authorized the FDA to oversee drug safety.
- Established requirements for drug labeling.
- Gave the FDA authority to inspect factories and seize unsafe products.
Durham-Humphrey Amendment (1951)
Amended the FDCA to establish two categories of drugs:
- Legend drugs (Rx only): Drugs that require a prescription because they are not safe for use without medical supervision. Must bear the legend "Rx Only" or "Caution: Federal law prohibits dispensing without a prescription."
- Over-the-counter (OTC) drugs: Drugs that are safe and effective for self-treatment without a prescription.
This amendment also authorized oral (verbal) prescriptions and refills of non-controlled legend drugs.
Kefauver-Harris Amendment (1962)
Enacted after the thalidomide tragedy (birth defects in other countries). Required:
- Drugs to be proven both safe AND effective before marketing.
- Manufacturers to report adverse drug reactions to the FDA.
- Informed consent for clinical trials.
- Good Manufacturing Practices (GMPs).
Controlled Substances Act (CSA) (1970)
Established the DEA and the five-schedule classification system for controlled substances. (See the Controlled Substances study guide for detailed coverage.)
Poison Prevention Packaging Act (1970)
Requires most prescription and certain OTC medications to be dispensed in child-resistant containers. Exceptions include:
- Sublingual nitroglycerin
- Oral contraceptives in manufacturer's dispenser packs
- Medications requested by the patient or prescriber to be dispensed in non-child-resistant containers (patient must sign a waiver)
- Inpatient/institutional medications
Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman Act) (1984)
Streamlined the approval process for generic drugs through the Abbreviated New Drug Application (ANDA). Generics must demonstrate bioequivalence to the brand-name product. Also provided patent extensions for brand-name drugs to compensate for time lost during FDA review.
Omnibus Budget Reconciliation Act (OBRA 90)
Required pharmacists participating in Medicaid to:
- Perform Drug Utilization Review (DUR) on Medicaid prescriptions.
- Offer counseling to Medicaid patients on new and refilled prescriptions.
- Maintain patient profiles.
Many states have extended these requirements to all patients, not just Medicaid recipients.
Health Insurance Portability and Accountability Act (HIPAA) (1996)
Protects patient health information. (See the HIPAA Compliance study guide for detailed coverage.)
Medicare Prescription Drug, Improvement, and Modernization Act (MMA) (2003)
Created Medicare Part D, providing outpatient prescription drug coverage through private insurance plans.
Combat Methamphetamine Epidemic Act (CMEA) (2005)
Regulates the sale of products containing pseudoephedrine, ephedrine, and phenylpropanolamine:
- Products must be kept behind the counter or in a locked case.
- Purchasers must show photo ID and sign a logbook.
- Daily purchase limit: 3.6 g per day.
- 30-day purchase limit: 9 g per 30-day period (7.5 g if purchased by mail order).
- Retailers must maintain sales records for at least 2 years.
- Employees must be trained on CMEA requirements.
Drug Quality and Security Act (DQSA) (2013)
Contains two titles:
- Title I - Compounding Quality Act: Created a new category of "outsourcing facilities" (503B facilities) that compound drugs without patient-specific prescriptions under FDA oversight. Distinguished from traditional pharmacy compounding (503A), which requires a patient-specific prescription.
- Title II - Drug Supply Chain Security Act (DSCSA): Established requirements for tracking and tracing prescription drugs through the supply chain (serialization, transaction documentation).
Dietary Supplement Health and Education Act (DSHEA) (1994)
Classified dietary supplements (vitamins, minerals, herbs, amino acids) as a category of food, not drugs. Supplements do not require FDA pre-market approval for safety or efficacy. Manufacturers are responsible for ensuring safety and truthful labeling. Supplements cannot claim to treat, cure, or prevent disease.
State vs. Federal Law
Key principle: When state and federal laws differ, the stricter law prevails. Examples:
- Federal law requires controlled substance records for 2 years; if a state requires 5 years, the state law applies.
- If a state prohibits the sale of pseudoephedrine without a prescription (stricter than federal), the state law applies.
State Board of Pharmacy
Each state has a Board of Pharmacy (BOP) that:
- Issues and renews pharmacy and pharmacist/technician licenses.
- Sets standards for pharmacy practice within the state.
- Investigates complaints and takes disciplinary action.
- Establishes continuing education requirements.
- Defines the scope of practice for pharmacy technicians.
Exam Tips
- Know the key federal laws and what each one accomplished.
- Durham-Humphrey created the distinction between Rx and OTC drugs.
- Kefauver-Harris added the effectiveness requirement.
- OBRA 90 required DUR and patient counseling for Medicaid.
- The Hatch-Waxman Act created the ANDA pathway for generics.
- CMEA limits: 3.6 g/day, 9 g/30 days for pseudoephedrine.
- When in doubt about state vs. federal law, follow the stricter standard.
- DSHEA means supplements are NOT subject to the same approval process as drugs.