Pharmacy Law
Created Medicare Part D
Medicare Modernization act 2003
Approves drugs, labeling, recalls
Food and Drug Administration (FDA)
The Act that banned over-the-counter sales of cold medicines that contain ingredients that are commonly used to make methamphetamine such as pseudoephedrine
Combat Methamphetamine Epidemic Act of 2005
The physical form of a drug (tablet, capsule, solution, ointment, etc.)
Solid form compressed into a disc or oval
Tablet
Required child resistant containers for most RX drugs
Poison Prevention Packaging Act (PPPA, 1970)
Enforces controlled substance laws
Drug Enforcement Administration (DEA)
Daily sales Limit of ephedrine based, pseudoephedrine base, or phenylpropanolamine base
3.6g
A unique 10- or 11-digit number identifying a drug’s manufacturer, product, and package size
NDC
Powder or liquid enclosed in gelatin shell
Capsule
Classified drugs into schedules I-V and rules for ordering, storage, recording keeping, and inventory
Controlled substances Act (CSA 1970)
In charge of workplace safety
Occupational safety and health administration (OSHA)
Amount of grams someone can buy in a 30 day period at a retail store
9g
The non-brand name of a medication (e.g., acetaminophen).
Generic Name
Liquid with drug particles that settle
Suspension
Required drugs to be proven safe before marketing
Entity in charge of drug standards, sterile/non sterile compounding
Unites States Pharmacopeia (USP)
Amount someone can buy in a 30 day period from a private or commercial carrier or postal service
7.5g
To prepare and provide medication as prescribed.
Dispense
Liquid with drug completely dissolved
Solution
Created prescription vs OTC category
Durham-Humphrey Amendment (1951)
Standard for compounding sterile preparations (CSPs)
USP Chapter 797
Difference between Sudafed PE and Pseudoephedrine (Sudafed)
Sudafed contains the active ingredient Pseudoephedrine, while the active ingredient in Sudafed PE is Phenylephrine.
Identifies a specific batch of medication for tracking/recall purposes.
Lot Number
Mixture of oil and water
Emulsion