Drug Acts

1906 ‒ Pure Food and Drug Act

- Enacted to stop the sale of inaccurately labeled drugs

-Manufacturers were required to:

-Provide truthful information on the label before a drug was sold

-Prove the drug’s effectiveness

1914 ‒ Harrison Narcotics Act

 Enacted to curb recreational use of opium  No longer available without a prescription

 Records required for prescriptions

 Importation and distribution were restricted

1938 ‒ Food, Drug, and Cosmetic Act

 Enacted because the 1906 law was not worded strictly enough and did not include cosmetics

 Required drug companies to include directions to the consumer regarding use of a drug, and also package inserts

 All addictive substances had to be labeled: “Warning: May be habit forming”

1938 ‒ Food, Drug, and Cosmetic Act

 Defined the exact labeling for products and defined misbranding and adulteration as illegal

 Requires the following:

 Mandatory food labeling

 Standards of identity

 Information on imitation foods

 Nutritional information for special dietary foods  Provided the legal status for the Food and Drug Administration (FDA)

1951 ‒ Durham-Humphrey

Amendment

 Required label on prescription drugs: “Caution: Federal law prohibits dispensing without a prescription.”

 Required a doctor’s order and supervision for certain drugs

 Made the initial distinction between legend drugs (by prescription only) and OTC

medications that do not require a doctor's order (non-prescription drugs)

1962 ‒ Kefauver-Harris

Amendments

 Enacted in an attempt to ensure the safety and effectiveness of all new drugs on the market

 Burden put on manufacturers to ensure “good manufacturing practice” (GMP)

 Prevented the sale of thalidomide in the United States; children in Europe were born with birth defects after mothers used drug during pregnancy

1970 ‒ Comprehensive Drug Abuse Prevention and Control Act

 Established the Drug Enforcement

Administration (DEA) to enforce the laws covering controlled substances and their distribution

 Created stair-step categories of controlled substances (Schedules I-V)

1970 ‒ Poison Prevention Packaging Act

 Required all medications to be placed in containers with childproof caps or packaging  Includes both OTC and legend drugs

 Exceptions include:

 Physician request for non-childproof cap

 Certain legend medications

 Hospitalized patients or patient request

1983 ‒ Orphan Drug Act and 1987 ‒ Prescription Drug Marketing Act

 Orphan Drug Act: Eased restrictions (and thus costs) for development of new drugs for those with a rare disease (affecting 1 in 200,000 people)

 Prescription Drug Marketing Act

 Helps prevent counterfeit drugs and ingredients from entering the supply chain

 Limits diversion of pharmaceutical samples and prescription drugs

1990 ‒ Omnibus Budget

Reconciliation Act (OBRA ’90)

 Deals specifically with practicing pharmacists  Enacted because of reimbursement

regulations for people who are covered by Medicaid or Medicare

 Requires pharmacists to counsel (at the time of purchase) all patients who receive new prescriptions

1996 ‒ Health Insurance Portability and Accountability Act (HIPAA)

 Deals with patient’s right to continuance of health insurance even when changing

employers

 Change for pharmacies: Pharmacists and technicians have direct knowledge of a patient’s medical information; the patient must sign a consent form to grant others access to this information

2000 ‒ Drug Addiction Treatment Act (DATA 2000)

 Physicians can prescribe controlled

substances to persons suffering from opioid addiction

 Only for maintenance or detoxification treatments

2003 ‒ Medicare Modernization Act

 Provides a drug discount card to those with low incomes who require assistance from a pharmacy company to obtain medications

2005 ‒ Combat Meth Act

 Addresses all areas of the manufacture and sale of pseudoephedrine (an ingredient used to make methamphetamine), as well as law enforcement

 Strict guidelines

 Only a licensed pharmacist or technician may dispense, sell, or distribute this drug2005 ‒

Combat Meth Act

2010 ‒ ACA and 2013 ‒ Drug Quality and Security Act

 Patient Protection and Affordable Care Act (ACA): Two important technician-related components:

 Electronic health records (EHR)

 Medication therapy management (MTM)

 Drug Quality and Security Act (DQSA)  FDA tracking system for bulk compounding supplies