N.J. Admin. Code § 13:39-11A.11

Current through Register Vol. 56, No. 21, November 4, 2024

Section 13:39-11A.11 - Beyond-use dates

(a) The beyond-use date is the date after which a compounded non-sterile preparation shall not be used. The beyond-use date shall be determined from the date the preparation is compounded. Because compounded preparations are intended for administration immediately or following short-term storage, beyond-use dates may be assigned based on criteria different from those applied to assigning expiration dates to manufactured drug products.

(b) In the absence of stability information that is applicable to a specific drug product and preparation, the following are the maximum beyond-use dates for non-sterile compounded drug preparations that are packaged in tight, light-resistant containers and stored at controlled room temperature unless otherwise indicated:

1. For nonaqueous liquids and solid formulations:

i. Where the manufactured drug product is the source of the active ingredient, the beyond-use date shall not be later than 25 percent of the time remaining until the product's expiration date or six months, whichever is earlier;

ii. Where a United States Pharmacopeia-National Formulary (USP-NF), analytical reagent (AR), certified American Chemical Society (ACS), or Food Chemicals Codex (FCC) grade substance is the source of the active ingredient, the beyond-use date shall not be later than six months or the expiration date of the ingredient, whichever is earlier; and

iii. Where there is more than one ingredient, the beyond-use date shall be no longer than six months or the expiration date of the first ingredient to expire, whichever is earlier;

2. For water-containing formulations (prepared from ingredients in solid form), the beyond-use date shall not be later than 14 days for liquid preparations when stored at cold temperatures between two degrees and eight degrees Celsius (36 degrees and 46 degrees Fahrenheit); and

3. For all other formulations, the beyond-use date shall not be later than the intended duration of therapy or 30 days, whichever is earlier.

(c) The beyond-use date limits established in this section may be exceeded only when there is supporting valid scientific stability information that is directly applicable to the specific preparation (that is, the same drug concentration range, pH, excipients, vehicle, water content, etc.).

N.J. Admin. Code § 13:39-11A.11