NAPLEX® Review Question of the Week: Compounding Concerns
A prescription order for a compounded product is received by your pharmacy. The prescription calls for the following ingredients to make a suspension:
Viscous lidocaine 2%
Maalox
Diphenhydramine 12.5 mg/5 mL
Carafate 1 gm/10 mL
Assuming that none of the ingredients expire any sooner than the next 6 months, what would the beyond-use date for this compounded product be?
A. 180 days
B. 30 days
C. 14 days
D. 90 days
Answer with rationale:
USP 795 sets the standards for compounded non-sterile preparations (CNSP) including beyond-use dates (BUDs). A BUD is not the same as an expiration date. Instead, a BUD indicates the last date that a CNSP can be used safely before being discarded. However, the BUD cannot extend past the expiration date of any of the components of the CNSP. In other words, if any ingredient used in the preparation of the CNSP expires before what would usually be the BUD, the BUD must be shortened to the time remaining until that ingredient expires. BUDs are determined by the type of preparation/dosage form involved. Solid dosage forms have a maximum BUD of 180 days at room temperature, preserved aqueous dosage forms have a maximum BUD of 35 days at room temperature, non-preserved aqueous dosage forms have a maximum BUD of 14 days when stored in the refrigerator, and non-aqueous dosage forms have a maximum BUD of 90 days at room temperature.
Answer A is incorrect. A 180-day BUD would be appropriate for a solid dosage form. This question is referring to a liquid dosage form, so this answer choice would be incorrect.
Answer B is incorrect. A 35-day BUD would be appropriate for a preserved aqueous dosage form. There were no preservatives listed in the ingredient list for this CNSP, so this answer choice would be incorrect.
Answer C is correct. The components of the prescription order listed above are all water-containing, and since there is no preservative listed in the ingredient list, this CNSP is classified as a non-preserved aqueous dosage form. As such, the maximum beyond use date for this product is 14 days when refrigerated.
Answer D is incorrect. A 90-day BUD would be appropriate for a non-aqueous dosage form. All of the ingredients listed for this CNSP are water-containing, so this answer choice would be incorrect.
Brands/generics covered:
Xylocaine (lidocaine), Maalox (aluminum hydroxide/magnesium hydroxide/simethicone), Benadryl (diphenhydramine), Carafate (sucralfate)
Naplex content domains covered:
1.B.1
Domain 1 Foundational Knowledge for Pharmacy Practice- B. Pharmaceutical Compounding 1. Nonsterile preparations
Dr. Christopher M. Bland is the Albert W. Jowdy Professor in Pharmacy Care at the University of Georgia College of Pharmacy at the Southeast GA campus in Savannah, GA. Dr. Bland has nearly 25 years of academic and clinical experience both in the inpatient and community patient care settings. He is a Fellow of both the Infectious Diseases Society of America as well as the American College of Clinical Pharmacy and has been named Teacher of the Year at the University of Georgia College of Pharmacy. He is co-author of the book "InteGREAT: A Guidebook for Creating Great Healthcare Teams."
He is co-founder of the Southeastern Research Group Endeavor, SERGE-45, with nearly 100 practitioners across 14 states involved. Dr. Bland serves as Associate Editor for the NAPLEX Review Guide 4th edition as well as upcoming 5th edition, as well as the Editor-In-Chief for the Question of the Week. He has provided hundreds of hours in live, interactive NAPLEX reviews for more than 10 Colleges/Schools of Pharmacy over the course of his career.
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