Pharm Tech Laws

1906 Food and Drug Act

Required government pre-approval of drugs

1914 Harrison Narcotic Act

This act limits the transport of opium. In order to purchase opium, a prescription is required.

1927 Food, Drug and Insecticide Administration

The law enforcement agency is formed that would be renamed in 1930 as the Food and Drug Administration.

1938 Food Drug and Cosmetic Act

Required that Drugs are proven safe when used according to directions

1951 Durham-Humphrey Amendment

This law defines what drugs require a prescription by a licensed practitioner and require the legend on its label

1962 Kefauver-Harris Amendment

Which amendment stated that all new drugs marketed had to be SAFE and EFFECTIVE.

1965 Social Security Act

Establishes the Medicare program.

1970 Poison Prevention Packaging Act

requires childproof packaging on all controlled and most prescription drugs dispensed by pharmacies

1970 Controlled Substances Act (CSA)

Which act classified 5 levels of drugs (controlled substances) that have potential for abuse and restricts their distribution. Establishes the DEA, under the Justice Department, to enforce its regulations.

1976 Medical Device Amendment

Requires pre-market approval for safety and effectiveness of life-sustaining and life-supporting medical devices.

1983 Orphan Drug Act

Provides incentives to promote research, approval, and marketing of drugs needed for the treatment of rare diseases.

1984 Hatch-Waxman Act

Provided for up to 5 year extension of patent protection

1990 Omnibus Budget Reconciliation Act (OBRA)

among other things this act required pharmacists to offer counseling to medicaid patients regarding medications ,effectively putting the common practice into law

1990 Anabolic Steroid Control Act

This act was passed to "address the abuse of steroids by athletes, and, especially, youngsters and teenagers."

1996 Health Insurance Portability and Accountability Act (HIPAA)

Establishes requirements for PHI (protected health information) to be secure in the pharmacy

2003 Medicare Modernization Act

Establishes optional Medicare Part D to provide coverage for prescription drugs and Medication Therapy Management (MTM)

2005 Combat Methamphetamine Epidemic Act

Establishes strict controls on OTC sales of pseudoephedrine, ephedrine, and phenylpropanolamine.

2007 FDA Amendments Act

Establishes Risk Evaluation and Mitigation Strategy (REMS) requirements for manufacturers of drugs and biologicals

2009 Health Information Technology for Economic and Clinical Health (HITECH) Act

Provides additions to HIPAA to include EMR and technology to PHI of patients

2010 Patient Protection and Affordable Care Act

Makes preventative care more accessible and affordable for many Americans

2012 FDA Safety and Innovation Act

Establishes user fees to enhance access to medications and medical devices and made provisions for addressing drug product shortages in the United States

2013 Drug Quality and Security Act

FDA tracking system for bulk compounding supplies