Week 2: Pharmacy References Flashcards
What is an Orange Book?
- Published by the FDA
- It lists drug products evaluated by the FDA.
- Each state, not the FDA, makes regulations about how drug products may be substituted
When can one drug be substituted for another?
Most states including MS use the Orange Book as the list of drugs that can be substituted for each other.
What is the MS BOP Regulations?
- The substituted drug product must be therapeutically equivalent to the prescribed drug.
What is pharmaceutical equivalent?
- Drug products in identical dosage forms and routes of administration that contain identical amounts of the identical active drug ingredient
- the same therapeutic moiety
- deliver identical amounts of the active drug ingredient over the identical dosing period
What can differ for pharmaceutical equivalents?
- Shape
- Scoring
- Release mechanism
- Packaging
- Excipients
- Expiration date/time
- Limits to labeling
What is bioequivalence?
The absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action
What is therapeutic equivalent?
Approved drug products that are pharmaceutical equivalents for which bioequivalence has been demonstrated, and that can be expected to have the same clinical effect and safety profile when administered to patients under the conditions specified in the labeling
What is the reference listed drug (RLD)?
The listed drug identified by FDA as the drug product upon which an applicant relies in seeking approval of its Abbreviated New Drug Application (ANDA)
What is a reference standard?
The drug product selected by FDA that an applicant seeking approval of an ANDA must use in conducting anin vivobioequivalence study required for approval
What is first letter of a therapeutic code?
Tells whether or not the drug is therapeutically equivalent to other pharmaceutically equivalent products.
What is A?
Drug products FDA considers to be therapeutically equivalent to other pharmaceutically equivalent products.
What is B?
Drug products that FDA considers to be NOT therapeutically equivalent to other pharmaceutically equivalent products.
What is the second letter of the therapeutic code?
Additional information – results of evaluation of bioequivalence problems (B) or the dosage form (A,N,O etc.)
What is AA?
No actual or potential bioequivalence problems.
What is AB?
products are therapeutically equivalent to the reference product and meet bioequivalence requirements. They can be substituted for the reference drug and each other
