laws

Drug Listing Act (1972)

• Amends the Federal food, drug and cosmetic act

• Prevents unfair or deceptive packages and labeling

• Provides FDA with accurate list of all drugs manufactured, prepared, compounded or processed by drug establishment

Orphan Drug Act (1983)

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

• Diseases like aids, cancer or genetic

Comprehensive Drug Abuse Prevention and Control Act (1970)

• Controlled Substance act

• Formed the DEA

  • Enforces laws concerning controlled substances and distribution

• Came from growing concern of use and abuse of amphetamines/barbiturates and other addictive agents

Health Insurance Portability Act and Accountability act

• HIPAA

• Federal act for protecting patient rights and establishing national standards for electronic healthcare communications and ensuring the security of health data

• Confidentiality and Disclosure

• Privacy Rights 

Food and Drug Administration (1862)

• Consists of chemist, physicians, veterinarians, lawyers, pharmacists, and microbiologists

• Investigates the adulteration and misbranding of agricultural goods used for food and drugs

Harvey Wiley (1902)

• Chief chemist changed FDA by established scientific authority by researching effects of chemical preservatives used in production of food and drugs

• Focused research on: exposing potential hazards in products, paved the way for government regulation

• In 1902, 13 children and 9 babies died after they were injected with a tainted batch of tetanus diphtheria antitoxins

Pure food and drug acts (1906)

• The act stopped the sale of inaccurately labeled drugs, so you know exactly what you are getting

• All manufacturers were required to have truthful information on the label prior to selling

• Drugs had to meet the standards of strength, quality, and purity

Harrison Narcotic Act (1906)

• Require practitioner registration, documentation regarding prescriptions and dispensing and implementation of restrictions regarding the importation, sale, and distribution of opium, cocoa leaves, and any derivative products

• Could no longer purchase opium without a prescription and therefore harder to get for nonmedical purposes

Federal Food, Drug, and Cosmetic Act (1938)

• Important concepts of this act were adulteration, misbranding and providing the legal status for the FDA. All addictive substances were required to be labeled

• Manufacturers had to prove to the FDA that a drug was safe for use before marketing it

• In 1937, a drug company advertised a sulfanilamide elixir for children. It was untested and more than 100 people died, chemical makeup was similar to antifreeze\

Durham-Humphrey Amendment (1951)

• Made the initial distinction between legend drugs and OTC medications that do not require a physician's order

• Required “caution: federal law prohibits dispensing without a prescription”

Kefauver-Harris Drug Amendment (1962)

• Ensured safety and effectiveness of all new medications in the US Market. Needed to provide safety

• Individual note of approval

• FDA had the authority to approve a manufacturers marketing application before drug was available

• Prevented sale of sedative thalidomide

Poison prevention Packaging act (1970)

• Required manufacturers and pharmacies to place all medications in container with childproof caps or packaging

• Include OTC and prescription medications, exception include physician request for non-childproof caps for patients; certain legend medications, hospitalized patients or specific patient request

• Estimated 1.4 childhood death are prevented annually due to childproof caps

Drug Supply Chain Security Act

• Amends Federal food, drug and cosmetic act

• Prevents unfair or deceptive packaging

• Introduced National Drug code (NDC) and provides FDA with accurate list of all drugs

Omnibus Budget Reconciliation Act (OBRA 87’)

• Addressed problems regarding quality healthcare for the elderly and set requirements for facilities participating medicare and medicaid programs

• Increasing number of elderly entering nursing homes, set standard care practices

• Pharmacist musts offer consults

Anabolic Steroids Acts (1990)

• Classified anabolic steroids as Class 3 controlled substances

• Because of anabolic steroids are misused by athletes, this act helps enforce regulations on abuse

Drug addictions treatment acts (Data 2000) (2000)

• Permit physicians to prescribe controlled substances (pre-approved by DEA) to individuals suffering from opioid addiction for detoxifications treatments

• Certain controlled substances can reduce craving for opioids and prevents withdrawal symptoms

• Patients must be in a treatment program, physicians must complete a trainer course and be certified by DEA, and can only treat 30 patients at once. After one year they can apply to treat up to 100 patients.

Medicare modernization Act (2003)

• Provides a drug discount card to beneficiaries with low incomes who require pharmacy company assistance for abstaining medication

• Allows dual coverage with Medicare and Medicaid

Combat Methamphetamine Act (2005)

• Was a response to the diversion and misuse of pseudoephedrine (PSE) to make meth

• Only a licensed pharmacist or technician may dispense, sell or distribute

• Purchase limits: 3.6 grams daily, 9 grams monthly (2-3 boxes)

• Must keep locked

Patient Protections and Affordable Care (Obamacare) (2010)

• Makes preventative care more accessible and affordable for many Americans

• Require insurance companies to cover all applicants with new minimum standards, including individuals with preexisting conditions.