Compounding

Question 1

What are the USP chapters dealing with compounding? (hint: non-sterile, sterile and safe handling of hazardous drugs)

Answer 1

1. USP <795> non-sterile
2. USP <797> sterile
3. USP <800> safe handling of hazardous drugs

Question 2

Per USP <800> what are considered hazardous drugs?(hint: six criteria)

Answer 2

1. Carcinogenicity
2. Teratogenicity or developmental toxicity
3. Reproductive toxicity in humans
4. Organ toxicity at low doses in humans or animals
5. Genotoxicity
6. New drugs that mimic existing hazardous drugs in structure or toxicity

Question 3

Do Iowa’s compounding regulations endorse USP compounding standards?

Answer 3

1. Iowa compounding regulations, chapter 20, requires that pharmacies engaged in compounding comply with USP <795) for nonsterile and USP <797> for sterile, among other rules.
2. Do not currently include USP <800>
3. One difference is that Iowa provides in exemption from following USP <795> for flavoring in pharmacy.

Question 4

Is flavoring considered compounding Iowa?

Answer 4

1. USP <795> recognizes flavoring as compounding: “Compounding involves mixing, altering, or assembling a drug and other ingredients.”
2. The BOP provides specific guidance in the state of Iowa that flavoring is exempt ref: IAC 20.13