N.J. Admin. Code § 13:39-11A.10 - Responsibilities of the compounding pharmacist; reporting requirement

(a) A compounding pharmacist shall be responsible for the ensuring that:

1. Compounded non-sterile preparations have been properly prepared, labeled, controlled, stored, dispensed, and distributed in accordance with the provisions of this subchapter;

2. All aspects of the compounding process set out in N.J.A.C. 13:39-11A.15 are documented and that accurate compounding records for all compounded non-sterile preparations prepared by the pharmacy are maintained;

3. Compounding personnel are capable of performing and qualified to perform their assigned duties;

4. Ingredients used in compounding have their expected identity, quality, and purity consistent with the requirements of N.J.A.C. 13:39-11A.12;

5. Compounded preparations are of acceptable strength, quality, and purity, with appropriate packaging and labeling, and are prepared in accordance with good compounding practices, official standards, and relevant scientific data and information as set forth in USP 795, which is incorporated herein by reference, as amended and supplemented, and which is available for purchase at the United States Pharmacopeia website, www.usp.org;

6. Critical processes are recorded and validated to ensure that procedures will consistently result in the expected qualities in the finished preparation;

7. The compounding environment is suitable for its intended purpose;

8. Appropriate stability evaluation is performed or is determined from the literature for establishing reliable beyond-use dating to ensure that the finished preparations have their expected potency, purity, quality, and characteristics, at least until the labeled beyond-use date;

9. Compounding conditions and procedures are in place to minimize the potential for errors;

10. Adequate procedures and records exist for investigating and correcting failures or problems in compounding, testing, or in the preparation itself; and

11. The patient is advised that the product dispensed is a compounded preparation.

(b) Any confirmed incidents of product contamination shall be reported by the pharmacist-in-charge to the New Jersey Board of Pharmacy within 48 hours of becoming aware of any such incidents.

Notes

N.J. Admin. Code § 13:39-11A.10

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