Pharm Tech- Chapter 2 Acts

1962 Kefauver-Harris Amendment

Ensures the safety and effectiveness of all new drugs on the U.S. market

2005 Combat Methamphetamine Epidemic Act

Addresses all areas related to manufacture of, enforcement of laws pertaining to, and sale of pseudoephedrine, which can be used to create methamphetamine

1983 Orphan Drug Act

Encourages drug companies to develop drugs for rare diseases by providing research assistance, grants, and cost incentives to manufacturers

1996 Health Insurance Portability and Accountability Act (HIPAA)

Federal act for protecting patients rights, establishing national standards for electronic health care communication, and ensuring the security and privacy of health data

1906 Federal Food and Drug Act

One of the first laws enacted to stop the sale of inaccurately labeled drugs

2003 Medicare Modernization Act

Provides a drug discount card to beneficiaries with low incomes who require pharmacy company assistance for obtaining medications

1987 Prescription Drug Marketing Act

Helps to avoid counterfeit drugs and ingredients in the supply chain and also helps limit diversion of pharmaceutical samples and prescription drugs

2010 Patient Protection and Affordable Care Act

Makes preventative care more accessible and affordable for many Americans

1938 Food, Drug, and Cosmetic Act

Important concepts of this act were adulteration, misbranding, and providing the legal status for the FDA

1970 Comprehensive Drug Abuse Prevention and Control Act

Requires manufacturers and pharmacies to place all medications in containers with childproof caps or packaging, including both over-the-counter and legend drugs

2000 Drug Addiction Treatment Act

Permits physicians to prescribe controlled substances (preapproved by the DEA) in schedules C-III, C-IV, or C-V to persons suffering from opioid addiction, for the purpose of maintenance or detoxification treatments

1951 Durham-Humphrey Amendment

Added more instructions for drug companies, required the labeling "Caution: Federal law prohibits dispensing without a prescription," and made the initial distinction between legend drugs and OTC medications that do not require a physician's order

2013 Drug Quality and Security Act

Gives greater oversight of bulk pharmaceutical compounding and enhances the agency's ability to track drugs through the distribution process

1970 Poison Prevention Packaging Act

Formed the DEA to enforce the laws concerning controlled substances and their distribution and introduced a stair-step schedule of controlled substances

1914 Harrison Narcotic Act

Required practitioner registration, documentation regarding prescription and dispensing, and implementation of restrictions regarding the importation, sale and distribution of opium, coca leaves, and any derivative products

1972 Drug Listing Act

Requires every drug to have a unique 10-digit number divided into three segments; numbers identify the labeler, product, and trade package size

1990 Omnibus Budget Reconciliation Act

Congressional act that changed reimbursement limits and mandated drug utilization evaluation, pharmacy patient consultation, and educational outreach programs

1994 Dietary Supplement Health and Education Act

Better defines the term dietary supplements; consumers must be informed of health-related benefits; manufacturers of these supplements are held to the same regulations; labels cannot mislead consumers and must include nutritional values

1990 Anabolic Steroids Control Act

Amends the Controlled Substances Act to add anabolic steroids as a schedule III substance and define "anabolic steroid" as any drug or hormonal substance that promotes muscle growth in a manner pharmacologically similar to testosterone

1997 Food and Drug Administration Modernization Act

Amendment to the Federal Food, Drug, and Cosmetic Act related to the regulation of food, drugs, devices, and biological products by the FDA