Pharmaceutical Laws and Regulations: Key Acts and Controlled Substances

1906 Pure Food & Drug Act (PFDA)

Required drugs/foods meet purity standards.

1914 Harrison Narcotic Act

Regulated narcotics (opium, marijuana, synthetic agents).

1938 Federal Food, Drug, & Cosmetic Act (FFDCA)

Defined adulteration/misbranding; required proof of safety.

1951 Durham-Humphrey Amendment

Distinguished prescription vs. OTC; introduced 'Legend Caution.'

1960 Federal Hazardous Substances Act

Required hazard labeling.

1962 Kefauver-Harris Amendment

Required proof of safety & efficacy before FDA approval.

1970 Poison Prevention Packaging Act

Required child-resistant containers.

1970 Controlled Substances Act (CSA)

Created drug schedules I-V; restricted transfers.

1970 OSHA Act

Ensured safe working conditions.

1972 Drug Listing Act

Required NDC codes for drugs.

1976 Medical Device Amendment

Regulated device safety.

1982 Anti-Tampering Act

Required tamper-proof packaging.

1983 Orphan Drug Act

Supported drugs for rare diseases.

1984 Prescription Drug Marketing Act

Addressed drug diversion.

1990 OBRA-90

Required counseling & DUR for Medicaid patients.

1990 Anabolic Steroids Control Act

Classified steroids as Schedule III.

1994 Dietary Supplement Health & Education Act

Classified supplements as food.

1996 HIPAA

Protected health information (PHI).

1997 FDA Modernization Act

Updated legend to 'Rx Only.'

2000 Drug Addiction Treatment Act

Allowed prescribers waivers for opioid addiction treatment.

2003 Medicare Modernization Act

Created Medicare Part D.

2005 Combat Meth Act

Regulated pseudoephedrine sales.

2005 Patient Safety Act

Encouraged reporting of adverse events.

2009 Tobacco Control Act

Regulated tobacco sales/marketing.

2013 Drug Supply Chain Security Act

'Track and Trace' to prevent counterfeit drugs.

The Joint Commission (TJC)

Accredits healthcare organizations; sets safety/quality standards.

OSHA

Ensures workplace safety; requires hazard communication.

FDA

Approves/monitors drugs, devices, and recalls; enforces labeling and monographs.

DEA

Enforces controlled substance laws; determines drug scheduling.

FTC Federal Trade Commission

Regulates OTC advertising and fair business practices.

State Boards of Pharmacy

Regulate pharmacy practice and technician requirements.

NABP National Association of Boards of Pharmacy

Supports state boards, exams, licensure transfer, and safety programs.

USP (United States Pharmacopeia)

Sets drug quality and compounding standards worldwide.

NPTA (National Pharmacy Technician Association)

Provides education, advocacy, and support.

AAPT (American Association of Pharmacy Technicians)

Established Code of Ethics for technicians.

ASHP (American Society of Health-System Pharmacists)

Supports pharmacists/technicians in health systems with education and training.

Schedule IV

Low abuse/dependence risk (e.g., Xanax, Valium, Ativan, Ambien, Tramadol).

Schedule V

Lowest abuse potential, often cough/diarrhea meds (e.g., Lyrica, Lomotil, Robitussin AC).

C-II Prescription Rules

No refills; new Rx required each time; cannot be transferred.

C-III & IV Prescription Rules

Up to 5 refills in 6 months; transferable once (unless pharmacies share database).

C-V Prescription Rules

No refill limit unless prescriber specifies; transferable once (or unlimited with shared database).

Recordkeeping Requirements

Must keep records for 2 years; C-II records kept separately; C-III-V may be separate or 'readily retrievable.'

Filing Options

3 files: C-II | C-III-V | Noncontrolled or 2 files: C-II | All others (C-III-V must be marked with red 'C').

DEA Form 222

Used for ordering/transferring/returning C-II drugs.

DEA Form 41

Used for destruction of controlled substances (requires DEA approval & 2 witnesses).

DEA Form 106

Used to report theft or significant loss.

CSOS

Controlled Substance Ordering System - Secure electronic ordering for Schedules I-V.

Initial Inventory

Exact count of C-II; estimated for C-III-V (unless >1,000 units → exact).

Biennial Inventory

Required every 2 years.

Storage Requirements

Locked cabinet OR dispersed throughout stock to prevent theft.

DEA Number Format

2 letters + 7 numbers (e.g., BD0865937).

Registrant Type

First letter = registrant type (A/B/F = practitioners, M = mid-level, X = opioid treatment waiver).

Checksum Method

Add odd digits + (even digits ×2) → last digit must match DEA's 9th digit.

HIPAA Purpose

Safeguards Protected Health Information (PHI) in oral, paper, and electronic forms.

Who Must Follow HIPAA

Health-care providers (pharmacies, hospitals, physicians), health plans, clearinghouses, and businesses handling PHI.

PHI Includes

Name, address, phone, birth date, Social Security number, insurance details, medical/prescription records, and anything that could identify a patient.

Key HIPAA Rules

PHI may only be used for treatment, payment, and health-care operations unless patient gives permission.

Pseudoephedrine Daily Limit

3.6 g per purchaser.

30-Day Pseudoephedrine Limit

9 g (retail); 7.5 g (mail order).

Investigational Drugs Types

Commercial, Research, Investigator IND, Emergency Use IND, Treatment IND.

Phases of Clinical Trials

Phase 1: 20-100 volunteers; safety & dosing (70% advance). Phase 2: Hundreds; effectiveness & side effects (33% advance). Phase 3: 300-3,000; long-term safety/effectiveness (25-30% advance). Phase 4: Post-marketing surveillance; long-term effects tracked via MedWatch.