N.J. Admin. Code § 13:39-11.17 - Batch preparation

(a) Pharmacists, pharmacy technicians, pharmacy interns, and pharmacy externs, consistent with N.J.A.C. 13:39-11.13, may compound sterile preparations in a quantity that is supported by prior valid prescriptions or medication orders before receiving a valid written prescription or medication order, provided the pharmacist:

1. Documents a history of valid prescriptions or medication orders subsequently received, within the beyond-use dating time of each product, which have been generated solely within an established professional prescriber-patient-pharmacist relationship;

2. Maintains the prescription or medication order on file for all such products dispensed at the pharmacy;

3. Documents the batch preparation process, including selection of the drugs, containers, and diluents, lot numbers and expiration dates of the drugs, containers, and diluents, if any, and verification that the compounded sterile preparation has been visually inspected to ensure the absence of particulate matter in solutions, the absence of leakage from vials and bags, and the accuracy and thoroughness of labeling. Each batch shall be given a unique batch number to identify the specific batch; and

4. Ensures that the labeling requirements set forth at N.J.A.C. 13:39-11.21(a)1, 5, 7, 9, and 10 are satisfied.

(b) Pharmacists, pharmacy technicians, pharmacy interns, and pharmacy externs shall not batch prepare compounded sterile preparations for human use without a prescription for a licensed prescriber to use in his or her practice, except to the extent permitted by Federal law. Anyone batch preparing compounds for non-human use without a prescription pursuant to this section shall comply with all requirements of N.J.A.C. 13:39-11.18 and the documentation requirements of N.J.A.C. 13:39-11.20(c).

Notes

N.J. Admin. Code § 13:39-11.17

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