Compounding

Question 1

USP-NF

Answer 1

united states pharmacopeia and the national formulary

Question 2

Chapter/USP 795

Answer 2

regulations from the USP-NF pertaining to compounding non-sterile formulations

Question 3

Chapter/USP 797

Answer 3

regulations from USP-NF pertaining to compounding sterile formulations

Question 4

Stability

Answer 4

the extent to which a dosage form retains the same properties and characteristics it possessed when it was made

Question 5

expiration date

Answer 5

required on commercially manufactured products and are determined after extensive study of the products stability. Most expirations dates are in the order of years

Question 6

Beyond-use-date (BUD)

Answer 6

different than an expiration date. These dates are only used for compounded preparations and are generally in the order of days or months

Question 7

Auxiliary Label

Answer 7

a label regarding specific warnings, foods, or medications to avoid, potential side effects, and other cautionary interactions - compounds MUST have an auxiliary label stating “this is a compound”
- for drugs that only need to be reconstituted and not compounded, the appropriate auxiliary labels must be used too. Some suspensions, for example, must be labeled “store in refrigerator” and “shake well”

Question 8

oral formulations containing water

Answer 8

not later than 14 days stored at a controlled cold temperature

Question 9

topical/semi-solid formulations (creams, pastes, ointments, gels) containing water; mucosal liquids (mouth coating rinses) containing water

Answer 9

not later than 30 days

Question 10

non-aqueous formulas

Answer 10

the earliest expiration date of any active principal ingredient (API) or 6 months, whichever is earlier