N.J. Admin. Code § 13:39-11.12

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

Section 13:39-11.12 - Pharmacist-in-charge responsibilities

(a) The pharmacist-in-charge shall supervise all sterile compounding performed by pharmacy personnel. The pharmacist-in-charge shall be trained in aseptic manipulation skills.

(b) The pharmacist-in-charge shall be responsible for, at a minimum, the following:

1. Determining the procedural, environmental, and quality control practices that are necessary for the risk levels he or she assigns to specific compounded sterile preparations;

2. Ensuring that the selected sterilization method both sterilizes and maintains the strength, purity, quality, and packaging integrity of the compounded sterile preparations;

3. Ensuring the placement in buffer areas and ante areas of equipment (for example, refrigerators), devices (for example, computers and printers) and objects (for example, carts and cabinets) that are not essential to compounding is dictated by their effect on the required environmental quality of air atmospheres and surfaces, which shall be verified by monitoring;

4. Storage of all materials pertinent to the compounding of sterile preparations, including drugs, chemicals, and biologicals, and the establishment of specific procedures for procurement of the materials in accordance with State and Federal laws and regulations;

5. Ensuring that all packaging and labeling of all compounded sterile preparations in the pharmacy are performed under the immediate personal supervision of a pharmacist;

6. Ensuring that preparation and compounding of sterile preparations is performed only by pharmacists who have been trained in aseptic manipulation skills, or by pharmacy technicians, pharmacy interns, or pharmacy externs who have been trained in aseptic manipulation skills working under the immediate personal supervision of a pharmacist trained in aseptic manipulation skills;

7. Recording all transactions of the pharmacy as may be necessary under applicable State, Federal, and local laws and rules, to maintain accurate control over, and accountability for, all pharmaceutical materials, and ensuring that policies and procedures exist with respect to the maintenance of the audit trail required pursuant to 13:39-11.20;

8. Ensuring that all pharmacists, pharmacy technicians, pharmacy interns, and pharmacy externs who compound sterile preparations are trained and evaluated consistent with the requirements of 13:39-11.16;

9. Establishing procedures for maintaining the integrity of the product and the manufacturer's control identity when repackaging sterile products. A pharmacist shall check all repackaging and shall initial the repackaging records;

10. Disposal of all unused drugs and materials used in compounding sterile preparations, including antineoplastic agents and other hazardous substances, in accordance with accepted professional standards, and the Medical Waste Act, 13:1E-48.1 et seq., so as not to endanger the public health;

11. Ensuring that the compounding area and its contents and other areas where compounded sterile preparations are present are secured, so as to prevent access by unauthorized personnel;

12. Ensuring that the pharmacy contains, in addition to the minimum reference library mandated in N.J.A.C. 13:39-5.8(a)1, the most recent edition of references pertinent to compounding sterile preparations;

13. Ensuring that records are maintained that document, at least twice daily, that appropriate controlled cold (refrigerator), controlled freezer, if applicable, and controlled room temperatures, as these terms are defined in United States Pharmacopeia 797, are maintained. Such records shall be maintained for no less than five years and shall be made available to the Board for inspection upon request;

14. Ensuring that all information required to be maintained as part of a pharmacy's patient profile record system pursuant to 13:39-7.19 or 9.19 is maintained for all compounded sterile preparations;

15. Ensuring that initial and ongoing multidisciplinary clinical monitoring and comprehensive care plans are maintained and readily available; and

16. Maintaining a policy and procedures manual detailing the pharmacy's standard operating procedures with regard to compounded sterile preparations, consistent with the requirements of N.J.A.C. 13:39-11.23, ensuring compliance with such policies and procedures, and maintaining a written quality assurance program, consistent with the requirements of N.J.A.C. 13:39-11.24.

N.J. Admin. Code § 13:39-11.12

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