N.J. Admin. Code § 13:39-11.25 - Prohibited compounding

(a) A pharmacist shall not compound preparations that contain drug products that appear on the Federal Food and Drug Administration's List of Drug Products Withdrawn or Removed from the Market for Reasons of Safety or Effectiveness, codified at 21 CFR 216.24.

(b) A pharmacist shall not compound any commercially available drug products unless:

1. The commercially available product is modified to produce a significant difference, in the professional judgment of the prescriber, between the compounded product for the patient and the comparable commercially available product; or

2. The commercially available product is not available from normal distribution channels in a timely manner to meet the patient's needs, and the dispensing of the compounded product has been approved by the prescriber and the patient.

(c) A pharmacist who compounds a commercially available product consistent with the requirements of (b) above shall maintain documentation of the reason for such compounding.

Notes

N.J. Admin. Code § 13:39-11.25

Adopted by 49 N.J.R. 3761(a), effective 12/4/2017