Pharmacy Law: Federal Laws & Regulatory Bodies

29 terms by carrotpigie

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short & sweet.

pure food and drug act

Prohibited selling adulterated (made less pure) or misbranded (improperly labeled) food and drugs.

food, drug, cosmetic act

All drug manufacturers must file New Drug Apps (NDA) with FDA prior to selling.

durham-humphrey amendment

Established which drugs were prescription (legend) and which were nonprescription (over the counter).

kefaurver-harris amendment

Meds need to be proven effective and safe.

controlled substance act

Divided controlled substances into 5 classes of varying abuse potential.

OSHA

Regulations for workplace, machinery, and equipment.

drug listing act

Each drug is assigned an NDC number that identified manufacturer, medication, size, and type of packaging.

federal hazardous substance act

Hazardous material must be discarded in marked containers.

orphan drug act

Financial incentive to producing medications for a rare disease (under 200k cases) that grants 7 year monopoly.

OBRA

Patients with Medicare/Medicaid must receive counseling.

anabolic steroids act

Anabolic steroids are CIII and regulated by CSA.

HIPAA

Concerns patient privacy.

fda modernization act

Safe pharmacy compounding.

combat methamphetamine epidemic act

Must present ID to purchase pure ephedrine/pseudoephedrine.

state boards of pharmacy

License and/or certify pharmacy personnel, oversee and discipline these professionals within their state.

drug enforcement agency

Focuses on major violators of the CSA. Seizes assets from violators.

food and drug admin

Uses system called MedWatch to receive info about adverse events or product problems.

national association of the boards of pharmacy

Assists state boards by developing uniform standards.

JCAHO

Accredits and certifies healthcare organizations in the U.S.

legislative law

Law drawn from U.S. congress and state legislatures.

administrative law

Law drawn from president or state governor and their cabinets.

common law

Aka case law. Drawn from court system.

criminal law

Law enforced by a state representative against persons or companies.

civil law

Plaintiff brings a suit against an alleged defendant.

contract law

Pertains to an agreement between two or more parties, enforced in civil court.

misdemeanor

Lesser crime punishable by fine and/or imprisonment of less than one year.

felony

Drug diversion, prescription forgery, theft.

tort

Physical/nonphysical injury one person inflicts on another, unintentional or not.

malpractice

Professional misconduct or negligence, the failure to exercise reasonable care. Monetary penalties.

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