Pharmacy Law and Regulations

Pure Food and Drug Act

1906 act ensuring food and drug purity standards.

Harrison Narcotic Act

1914 act regulating drugs causing dependence.

Federal Food, Drug, and Cosmetic Act

1938 act requiring drug safety proof by manufacturers.

Durham-Humphrey Amendment

1951 amendment requiring prescriptions for legend drugs.

Kefauver-Harris Amendment

1963 amendment ensuring drug safety and efficacy.

Orphan Drug Act

1983 act easing restrictions for rare disease drugs.

Prescription Drug Marketing Act

1987 act preventing counterfeit drugs in supply chain.

Omnibus Budget Reconciliation Act

1990 act requiring counseling for new prescriptions.

Drug Utilization Evaluation

Reviewing medication appropriateness and interactions.

Patient Confidentiality

Protection against unauthorized disclosure of patient info.

Protected Health Information

Individually identifiable health information protection.

Combat Meth Act

2005 act regulating pseudoephedrine sales to combat meth.

Functions of the FDA

Ensures medication safety and effectiveness.

Functions of the DEA

Prevents illegal distribution of controlled substances.

MedWatch

FDA program for reporting drug discrepancies.

Monographs/Package Inserts

Documents detailing drug information and warnings.

Pregnancy Categories

FDA categories assessing drug risks during pregnancy.

Prescription Regulations

Rules governing who can prescribe medications.

Prescription Labels

Information required on medication dispensing labels.

Repackaging

Transferring bulk medications into smaller doses.

DEA Verification

Process to confirm prescriber's legitimacy for prescriptions.

Verifying DEA Number

Steps to authenticate a DEA registration number.

Drug Abuse and Dependence

Potential for drugs to cause addiction or misuse.

Adverse Reactions Reporting

Reporting serious medication side effects to FDA.

Caution Legend

Label indicating prescription requirement for medications.

Boxed Warning

Severe warning about drug risks in labeling.

MedGuides

Printouts for patients on specific medication risks.

Pharmacy Technician

Handles prescriptions but cannot take phone orders.

Pharmacist

Final check on prescriptions and takes verbal orders.

Prescription Label

Contains pharmacy and patient information.

Teratogenicity

Medication causing birth defects in unborn fetuses.

DEA Number

Nine-character code identifying registered prescribers.

Controlled Substances

Addictive drugs regulated by the DEA.

Narcotics

Derived from opium; have analgesic effects.

Scheduled Substances

Five levels based on potential for abuse.

Tamper-Proof Prescriptions

Security features to prevent forgery and fraud.

Material Safety Data Sheet (MSDS)

Details safety information for chemicals.

Joint Commission

Accredits healthcare organizations for safety and quality.

Ethics

Set of professional values guiding behavior.

Recalled Drugs

Classified into three categories based on risk.

Risk Management Programs

Programs for safe prescription drug use.

Form 224

Registration form for pharmacies to dispense controlled substances.

Form 222

Used for purchasing C-II controlled substances.

Refilling Controlled Substances

C-III to C-V can be refilled five times.

Partial Filling of C-II

Must complete within 72 hours.

Reverse Distributor

Handles returns of unwanted controlled substances.

Occupational Safety and Health Administration (OSHA)

Oversees workplace safety regulations.

Pharmacy Sites

Includes brick-and-mortar, mail-order, and e-pharmacies.

Negligence

Legal liability for mistakes in pharmacy practice.

Expiration Date

Date after which medication should not be used.

Pharmacy Information

Includes name, address, and phone number.

Patient Information

Includes name and relevant health details.

Caution Labels

Warnings included on prescription labels.

Controlled Substance Act

Regulates the purchase and distribution of narcotics.

Emergency C-II Fill

Allowed via verbal order in emergencies.

Inventory Management

Pharmacists validate counts of controlled substances.

Drug Diversion

Misuse of drugs intended for medical purposes.