Federal Pharmacy Law
Required proof of drug effectiveness and safety
Kefauver-Harris Amendment (1962)
Strong likelihood of a product causing serious adverse effects or death
Class 1
Written or electronic order for medication issues by a licensed provider
Prescription
What the patient is required to pay
Co-Pay
Health insurance portability and accountability act to protect patient safety
HIPAA
Incentive for rare disease drugs
Orphan Drug Act (1983)
Product may cause temporary but reversible adverse effects or there is little likelihood the product will cause serious harm
Class 2
Physical form of a drug
Dosage Form
List of medications approved by insurance or P&T committees in hospital setting
Formulary
FDA program for reporting adverse drugs
MedWatch
Prevents counterfeit drugs, regulates drug samples
Prescription drug marketing act (PDMA 1987)
Product is not likely to cause adverse effect
Class 3
Unique 10–11-digit number identifying a drug’s manufacturer, product, and package size
NDC- National Drug Code
Identifies the insurance plan for insurance claims. Located on the patient insurance card
BIN Number
United States Pharmacopeia (USP) standard for compounding sterile preparations (CSPs), which are medications that must be sterile to prevent harm to patients from microbial contamination, endotoxins, or errors in ingredients
USP 797
Mandates pharmacist counseling for Medicaid patient, prospective drug review
Omnibus Budget Reconciliation Act (OBRA 1990)
Unintended side effect of a medication that is negative or in some way injurious to a patient’s health
Adverse effect
Identified the specific batch of medication for tracking and recall purposes
Lot Number
Processor Control Number. Secondary Insurance Identifier. Located on the patient insurance card
PCN
Provides standards for compounding quality nonsterile preparations.
USP 795
To regulate, among other things, retail over-the-counter sales of EPH, PSE, and PPA products which are common ingredients found in cold and allergy products.
Combat Methamphetamine Epidemic Act
Where you go for a list of medication recalls
FDA
Date at which the compounded medication or opened medication should no longer be used
Beyond Use Date (BUD)
Date at which point the manufacturer states it no longer guarantees the potency/safety
Expiration Date
United States Pharmacopeia general chapter outlining standards for the safe handling of hazardous drugs (HDs) to protect healthcare workers, patients, and the environment from harmful exposure. It covers the entire process of HD management, from receipt and storage to dispensing, administration, and disposal of both sterile and non-sterile products.
USP 800