Legal
Terminology
Terminology
This term refers to a civil wrong or injury, such as a pharmacy medication error committed against a person that results in legal liability.
Tort
This 1970 law requires pharmacies to use child-resistant caps on most prescription bottles.
Poison Prevention Packaging Act (PPPA)
This is the literal translation of the prescription abbreviation “PRN,” which dictates how often a patient can take a medication like a pain reliever.
As needed
This is the total number of refills allowed on a Schedule II narcotic prescription.
Zero
This specific safety warning is a dark, bold border at the top of a drug paper that warns of life-threatening risk.
Black Box Warning
This legal term describes a pharmacy technician‘s failure to provide the standard of care that a reasonable peer would provide in the same situation.
Negligence (or Malpractice)
This is the 10-digit number broken into three parts that acts like a barcode identifier for a drug.
National Drug Code (NDC)
This mandatory part of a label tells the patients exactly how and when to take their medicine
The Sig
Drugs in this schedule have a high risk of abuse, no accepted medical use, and cannot be prescribed at all.
Schedule I
This standard paper handout must be given to patients every single time they fill birth controlled pills.
Patient Package Insert (PPI)
This term applies to a a medication label that is false, misleading, or missing mandatory information like expiraton dates or safety warnings.
Misbranding
This 1951 amendment to the FDCA established a clear distinction between prescription (“legend”) drugs and over-the-counter (OTC) medications.
Durham-Humphrey Admendment
What organization has best recommendation regarding verbal prescriptions?
MERP
Prescriptions for Schedule III and IV drugs expire after this many months.
6 months
These official FDA paper guides are required for risky drugs like antidepressants to warn patients about serious side effects.
Medication Guides (MedGuides)
This legal standard dictates that a pharmacy technician must keep all patient health informations private and protected under HIPPA rules.
Confidentiality (or Patient Privacy)
This federal agency enforces the laws regarding controlled substances and narcotics in the United Sates .
DEA (Drug Enforcement Administration)
This reference book is what a technician uses to check if a generic drug is legally equivalent to a brand-name drug.
The Orange Book
A pharmacy must fill out DEA Form 106 If they experience this emergency event
Theft and significant loss of controlled drugs
Passed in 1990, this federal act _____ mandates that a pharmacist must offer counseling to patients on their new prescriptions.
Omnibus Budget Reconciliation Act (OBRA-90)
This specific legal defense states that a technician or pharmacist is expected to perform up to the level of quality that a reasonable peer would in the same communit.
Standard of Care
This landmark 1938 act required all new drugs to be proven safe before marketing and authorized factory inspections by the FDA.
Food, Drug, and Cosmetic Act (FDCA)
This 9-character numbers is issued by the government to doctor so the are legally allowed to prescribe controlled drugs.
DEA number
This specific federal form or electronic tracking system (CSOS) must be used by a pharmacy to order Schedule II narcotic medications.
DEA Form 222
This strict safety program (abbreviated REMS) is enforced by the FDA for high-risk medications like Isotretinoin (Accutane) to manage known serious risks.
Risk Evaluation and Mitigation Strategy