29 terms

Pharmacy Law: Federal Laws & Regulatory Bodies

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.
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.
Patients with Medicare/Medicaid must receive counseling.
anabolic steroids act
Anabolic steroids are CIII and regulated by CSA.
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.
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.
Lesser crime punishable by fine and/or imprisonment of less than one year.
Drug diversion, prescription forgery, theft.
Physical/nonphysical injury one person inflicts on another, unintentional or not.
Professional misconduct or negligence, the failure to exercise reasonable care. Monetary penalties.