Misc. Federal Laws Flashcards
Investigational New Drug Application (IND)
The first application form that a sponsor must submit to the FDA before a drug may be administered to humans
Once the IND is submitted the FDA has ___ days to decide whether the drug is suitable for testing.
30 days
Fast Track
intended for drugs that address unmet medical need by either treating a condition for which no other treatment exists or drugs that offer substantial benefit over existing treatment
Breakthrough Therapy
similar to fast track but show substantial improvement over existing therapies
Accelerated Approval
Intended for drugs with long-term endpoints such as increased survival or decreased morbidity that are difficult to measure efficiently in trials
Information required on each unit-dose package
- Generic name and trade name
- Quantity of active drug
- Name of manufacturer
- LOT number
- Expiration date
Class I Drug Recall
Serious adverse health consequences including death
Class II Drug Recall
The drug product may cause temporary or reversible effects but the probability of serious adverse effects is remote.
Class III Drug Recall
The drug product is unlikely to cause any adverse health consequences.
Expiration Dating for Compounded Prescriptions
- Nonaqueous liquids and solids: not more than 25% of the time remaining on commercial product or max of six months
- Aqueous solutions: 14 days when stored at cold temp
- All others: for the duration of therapy but not more than 30 days
Low Risk Compounding of Sterile Products
Techniques involving commercially available sterile products that are manufactured in a closed system ie. transfer of solution from a vile with a needle, compounding TPN using commercially available solutions
High-Risk Compounding of Sterile Products
Category I: Complex involving numerous aseptic processes
Category II: greatest risk of contamination (using non-sterile drug substances, “open-systems”
MedGuides are usually required when…
- Patient labeling could prevent serious adverse effects
- The product has serious risks relative to benefits
- Patient adherence to directions is crucial
Labeling Requirements for OTCs
Active ingredient, Uses, Warnings, inactive ingredients, purpose, directions, other information
