High‑Yield Safety & Quality Control Set

REMS,RECALL

 What does FDAAA relate to?

REMS authority

DRUG APPROVAL PIPELINE

Preclinical → IND : Lab + animal testing → company asks FDA for permission to start human trials.

Phase I : 20–80 healthy volunteers → safety + dosage.

Phase II : 100–300 patients → efficacy + safety.

Phase III : 1,000–5,000 patients → confirm efficacy + monitor adverse effects.

NDA → FDA Review : Company requests FDA approval to market the drug.

Phase IV : Post‑market monitoring → long‑term safety in the real world.

FDA RECALL CLASSE 1

• Product may cause serious harm or death.

FDA RECALL CLASSE 2

 temporary/reversible harm

FDA RECALL CLASSE 3

Unlikely to cause harm.

What book lists therapeutic equivalents?

Orange Book.

What does AB‑rated mean?

Pharmaceutically equivalent + bioequivalent → substitutable.

What is REMS?

FDA safety program for drugs with serious risks.

What is a Medication Guide?

FDA‑required patient risk information.

What is ETASU?

Extra requirements to assure safe use.

What is a Communication Plan?

Educates healthcare professionals.

What is an Implementation System?

System used to enforce REMS requirements.

iPLEDGE REMS drug?

Isotretinoin → pregnancy risk (severe birth defects) → RMA required.

TIRF REMS drug?

Transmucosal fentanyl → overdose/misuse risk.

Addyi and Clozapine REMS status?

REMS discontinued (risk still exists).

Storage Temperatures: Freezer temperature?

−25°C to −10°C

Storage Temperatures : Refrigerator temperature?

2°C to 8°C

Storage Temperatures : Room temperature?

20°C to 25°C

USP <795>

Rule for Nonsterile compounding product

USP <797>

Rule for Sterile compounding product

USP <800>?

Rule for Hazardous drugs