Nonaqueous 'Other' Formulation BUD?

Nonaqueous 'Other' Formulation BUD?

• A. 14 days
• B. 28 days
• C. 90 days
• D. 180 days

Answer: (D)

Nonaqueous formulations lack water, which greatly reduces the risk of microbial growth, so the allowed beyond-use date is longer. For these nonaqueous or “other” formulations, the USP guidelines set a BUD of six months (180 days) from the date of compounding, unless the preparation has an earlier expiration date. That’s why 180 days is the best choice. The other time frames apply to different types of formulations (for example, water-containing products have shorter BUDs due to higher microbial and hydrolytic risk).

Nonaqueous formulations lack water, which greatly reduces the risk of microbial growth, so the allowed beyond-use date is longer. For these nonaqueous or “other” formulations, the USP guidelines set a BUD of six months (180 days) from the date of compounding, unless the preparation has an earlier expiration date. That’s why 180 days is the best choice. The other time frames apply to different types of formulations (for example, water-containing products have shorter BUDs due to higher microbial and hydrolytic risk).