Pharmacy Tech Federal Laws

provided financial benefits for patients eligible for Medicare, specifically Medicare Part D which deals with prescription drug plans

• Pure Food and Drug Act, 1906

• Food, Drug and Cosmetic Act, 1938

• Combat Methamphetamine Epidemic Act, 2005

• Medicare Prescription Drug, Improvement, and Modernization Act, 2003

The first piece of legislation that regulated drugs. The act outlawed interstate distribution or sale of compromised or misbranded foods or drugs. “Compromised” here refers to the manufacture of foods or drugs in unsafe or unhygienic environments or produced to a poor standard, quality, purity, or strength.

• Pure Food and Drug Act, 1906

• Food, Drug and Cosmetic Act, 1938

• Combat Methamphetamine Epidemic Act, 2005

• Medicare Prescription Drug, Improvement, and Modernization Act, 2003

This act was passed in the wake of the sulfanilamide tragedy – where over 100 patients lost their lives when the Massengill company used antifreeze (diethylene glycol) as a sweetening agent in an elixir.

The act mandates that manufactures who wish to release a new drug to the market must file an NDA – or New Drug Application – with the FDA, the Food and Drug Administration.

• Pure Food and Drug Act, 1906

• Food, Drug and Cosmetic Act, 1938

• Combat Methamphetamine Epidemic Act, 2005

• Medicare Prescription Drug, Improvement, and Modernization Act, 2003

The function of this 2005 Act was to prevent the use and manufacture of methamphetamine.

This meant locking up drugs – such as ephedrine and pseudoephedrine and others – that are mentioned and listed in the act. Furthermore, it limited the amount of ephedrine or pseudoephedrine to 3.6g for any one individual purchase, and 9g in one month.

• Pure Food and Drug Act, 1906

• Food, Drug and Cosmetic Act, 1938

• Combat Methamphetamine Epidemic Act, 2005

• Medicare Prescription Drug, Improvement, and Modernization Act, 2003

This was a much-needed amendment to the Food, Drug and Cosmetic Act. Up until 1951, many prescription drugs were given to patients in the same manner as OTC medicines. There were no specific guidelines or regulations in place to tightly control how and when prescription drugs were dispensed. Pharmacies were dispensing prescription drugs to patients who did not have a prescription. Senators Hubert Humphrey and Carl Dunham – to whom the amendment owes its name – established clear criteria as to what constituted a “prescription drug” and the circumstances in which it can be dispensed to a patient. It outlawed the action of dispensing a prescription (“legend”) drug to those who did not have a prescription – remedying this long-standing problem.

The label, “Caution: Federal law prohibits dispensing this medication without a prescription”, would now have to be present on all prescription medicine

• Poison Prevention Packaging Act, 1970

• Controlled Substances Act, 1970

• Durham-Humphrey Amendment, 1951

• Kefauver-Harris Amendment, 1963

enacted to ensure that medicines were child resistant.

• Poison Prevention Packaging Act, 1970

• Controlled Substances Act, 1970

• Durham-Humphrey Amendment, 1951

• Kefauver-Harris Amendment, 1963

This amendment was passed because dubious and potentially lethal medicines were being sold to the public. The amendment sought to guarantee the safety, purity, and efficacy of both prescription and non-prescription medicines; eliminating the risk of dubious or harmful medicines being released into the public sphere.

The amendment was also passed in the wake of the thalidomide tragedy, in which tens of thousands of birth defects were caused by thalidomide; a drug marketed to pregnant women for the treatment of morning sickness.

• Requires that pharmaceutical manufacturing sites are registered and permit inspections as and when these inspections are needed.

• Placed drug advertising under the remit of FDA supervision.

• Poison Prevention Packaging Act, 1970

• Controlled Substances Act, 1970

• Durham-Humphrey Amendment, 1951

• Kefauver-Harris Amendment, 1963

also known as the Comprehensive Drug Abuse Prevention and Control Act – was passed in 1970 and sought to introduce measures for the safe organization of controlled substances.

• Poison Prevention Packaging Act, 1970

• Controlled Substances Act, 1970

• Durham-Humphrey Amendment, 1951

• Kefauver-Harris Amendment, 1963

Key provisions for the pharmacy field include requirements for drug utilization review, maintaining patient records, and offering patient counseling for Medicaid recipients, which went into effect in 1993. The Act also established the Medicaid Drug Rebate Program, mandating rebates from drug manufacturers to state Medicaid agencies. 

• Poison Prevention Packaging Act, 1970

• Omnibus Budget Reconciliation Act, 1990

• Durham-Humphrey Amendment, 1951

• Kefauver-Harris Amendment, 1963

______ drugs are drugs used to treat a rare disease.

Because these diseases are rare, there is less financial incentive for pharmaceutical companies to develop drugs to treat these conditions.

The ________, offered financial incentives to encourage drug manufacturers to develop drugs – known as orphan drugs – to treat these rare diseases.

An example of an orphan drug is penicillamine which was developed to treat the orphan disease, Wilson’s disease – a disease in which patients accumulate too much copper in the body

• Federal Hazardous Substances Act, 1960

• Occupational Health and Safety Act, 1970

• Drug Listing Act, 1972

• Orphan Drug Act, 1983