What is the BUD for Nonaqueous 'Other' Formulation?

What is the BUD for Nonaqueous 'Other' Formulation?

• A. 14 days: Refrigerated
• B. 35 days: Refrigerated
• C. 90 days: Refrigerated
• D. 180 days: Refrigerated

Answer: (D)

For nonaqueous formulations, the beyond-use date is limited to six months from the date of preparation (or the earliest expiration of any ingredient, whichever comes first). Because there is no water in these preparations, the risk of microbial growth is low, so you don’t use shorter time frames typical of water-containing products. Therefore, the maximum BUD here is 180 days, and refrigeration can be used if the formulation or ingredients require it, but it doesn’t change the six-month limit. The other options are shorter than the allowed six-month limit and aren’t correct for nonaqueous formulations.

For nonaqueous formulations, the beyond-use date is limited to six months from the date of preparation (or the earliest expiration of any ingredient, whichever comes first). Because there is no water in these preparations, the risk of microbial growth is low, so you don’t use shorter time frames typical of water-containing products. Therefore, the maximum BUD here is 180 days, and refrigeration can be used if the formulation or ingredients require it, but it doesn’t change the six-month limit. The other options are shorter than the allowed six-month limit and aren’t correct for nonaqueous formulations.