Federal Regulations

Federal laws establish the foundation for pharmacy practice across all states. Understanding these regulations is essential for the ExCPT exam and for maintaining compliance in daily pharmacy operations.

HIPAA - Health Insurance Portability and Accountability Act

HIPAA (1996) is the primary federal law protecting patient health information. It established national standards for electronic healthcare transactions and privacy requirements.

HIPAA Privacy Rule

The Privacy Rule establishes standards for protecting Protected Health Information (PHI).

PHI includes:

• Patient names, addresses, phone numbers
• Medical records and prescription history
• Insurance and billing information
• Any information that can identify a patient

Key HIPAA Requirements for Pharmacies

HIPAA Violations and Penalties

Permitted PHI Disclosures

PHI may be disclosed without patient authorization for:

• Treatment - Sharing information with other healthcare providers
• Payment - Insurance billing and claims processing
• Healthcare Operations - Quality improvement, training
• Public Health Activities - Disease reporting, FDA reporting
• Law Enforcement - Court orders, subpoenas (with proper documentation)

Exam Tip

Remember the TPO rule: Disclosure without authorization is permitted for Treatment, Payment, and healthcare Operations.

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FDA - Food and Drug Administration

The FDA regulates drugs, biologics, medical devices, and food safety. For pharmacy technicians, understanding FDA drug regulations is most relevant.

Key FDA Functions

FDA Drug Recall Classifications

National Drug Code (NDC)

The FDA assigns a unique 10-digit NDC number to each drug product.

NDC Format: XXXXX-XXXX-XX

• First segment (5 digits): Manufacturer/labeler
• Second segment (4 digits): Product code (drug, strength, dosage form)
• Third segment (2 digits): Package size

Example: 00002-3231-30 identifies a specific manufacturer, product, and package size

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Poison Prevention Packaging Act (PPPA)

The Poison Prevention Packaging Act (1970) requires most prescription and OTC medications to be dispensed in child-resistant containers.

Requirements

• Packaging must be significantly difficult for children under 5 to open
• Must be tested and certified to meet opening standards
• Applies to most prescription drugs and many OTC products

Exceptions (Non-Child-Resistant Packaging Allowed)

Documentation

When non-child-resistant containers are dispensed:

• Patient request must be documented
• Some pharmacies use blanket waivers; others document each instance
• Patient assumes responsibility for safe storage

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OBRA-90 - Omnibus Budget Reconciliation Act

OBRA-90 (1990) established requirements for pharmacies serving Medicaid patients, though most pharmacies apply these standards to all patients.

Key OBRA-90 Requirements

Prospective Drug Utilization Review

Pharmacists must review prescriptions for:

• Therapeutic duplication - Two drugs that do the same thing
• Drug-drug interactions - Dangerous combinations
• Incorrect dosage - Too high or too low
• Drug-disease contraindications - Medications inappropriate for patient conditions
• Drug-allergy interactions - Known patient allergies
• Clinical abuse/misuse - Patterns suggesting inappropriate use

Role of Pharmacy Technicians in OBRA-90 Compliance

While technicians cannot perform DUR or counseling, they support compliance by:

• Accurately entering patient information (allergies, conditions, other medications)
• Flagging potential issues for pharmacist review
• Documenting offers of counseling (per pharmacy policy)
• Maintaining accurate patient profiles

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Combat Methamphetamine Epidemic Act (CMEA)

The CMEA (2005) restricts the sale of products containing pseudoephedrine, ephedrine, and phenylpropanolamine due to their use in methamphetamine production.

CMEA Requirements

State Variations

Some states have additional restrictions:

• Prescription-only requirements (Oregon, Mississippi)
• Electronic tracking systems (NPLEx)
• Lower quantity limits

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Other Important Federal Laws

Drug Supply Chain Security Act (DSCSA)

• Establishes requirements for tracking pharmaceutical products through the supply chain
• Requires transaction information, history, and statements (T3)
• Working toward full interoperable electronic tracing by 2023+

Isotretinoin Safety (iPLEDGE Program)

• FDA-mandated risk management program
• Requires registration of prescribers, pharmacies, and patients
• Monthly pregnancy tests for females of childbearing potential
• 7-day dispensing window after pregnancy test

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Key Takeaways

• HIPAA protects patient health information (PHI) and requires privacy safeguards.
• The FDA regulates drug safety, efficacy, manufacturing, and labeling.
• The Poison Prevention Packaging Act requires child-resistant containers for most medications.
• The Omnibus Budget Reconciliation Act (OBRA-90) mandates prospective drug utilization review.
• The Combat Methamphetamine Epidemic Act restricts pseudoephedrine sales.