N.J. Admin. Code § 13:39-5.8

Current through Register Vol. 56, No. 24, December 18, 2024

Section 13:39-5.8 - Minimum equipment and supplies; cleanliness

(a) All prescription areas shall contain the following minimum equipment and supplies, which shall be readily accessible:

1. The most recent edition of comprehensive pharmaceutical reference text(s) and suitable reference texts encompassing the pharmaceutical services provided by the pharmacy, drug interactions, drug product composition and patient counseling. Unabridged electronic versions of such reference texts shall be acceptable;

2. Over the counter Schedule V Record Book or an electronic recording system, as permitted by Federal law pursuant to 21 CFR 1306.26 and 1304.04, to maintain all required information consistent with N.J.A.C. 13:45H-7.19(a)5, if Schedule V controlled substances are sold without a prescription;

3. Permanent prescription filing device and patient profile record system;

4. Storage place of substantial construction, which is capable of being securely locked when the pharmacist is not present in the prescription dispensing area, for Schedule II controlled substances, if not dispersed;

5. Suitable volumetric devices;

6. A steel spatula and a spatula of rubber or composition;

7. Refrigerator, as required by United States Pharmacopoeia Standards, to be used only for the storage of pharmaceuticals;

8. Refrigerator thermometer and, if applicable, freezer thermometer, or temperature monitoring device to enable control of temperature;

9. Suitable counting trays or approved counting device;

10. Labels;

11. Auxiliary labels;

12. The signage required pursuant to N.J.S.A. 24:6E-10, the 29th edition of the list of "Approved Drug Products with Therapeutic Equivalence Evaluations," commonly known as the "Orange Book," which is incorporated herein by reference, as amended and supplemented. The Orange Book can be obtained by contacting the Superintendent of Documents, Government Printing Office, PO Box 371954, Pittsburgh, PA 15250-7954, (202) 512-1800 or toll free (866) 512-1800, and is available online at http://www.fda.gov/cder/orange/default.htm and at http://www.fda.gov/cder/ob/default.htm, and the lists of "Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations," commonly known as the "Purple Book," which is incorporated herein by reference, as amended and supplemented. The Purple Book can be found online at http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/Therapeutic [File Link Not Available]

13. Assorted stock of prescription containers and child safety closures or caps that meet the standards on light resistance, tightness, and water vapor permeation of Chapter 661 and moisture permeability of Chapter 671 of the United States Pharmacopoeia/National Formulary, 2014 edition, which are both incorporated herein by reference, as amended and supplemented, and are available for purchase at the United States Pharmacopeia/National Formulary website at www.usp.org; and

14. Copies of, or access to, current State statutes and rules relating to the practice of pharmacy.

(b) All prescription areas where non-sterile compounding is performed shall contain the following minimum equipment and supplies, which shall be stored, so as to be readily accessible:

1. Class A prescription balance with a complete set of metric weights or equivalent electronic weighing device;

2. A glass mortar and pestle;

3. Glass funnels;

4. Stirring rods; and

5. Ointment tile or parchment paper.

(c) The prescription area and all related equipment and supplies shall be kept in a clean, orderly and sanitary condition at all times.

N.J. Admin. Code § 13:39-5.8

Amended by 47 N.J.R. 120(a), effective 1/5/2015

Amended by 49 N.J.R. 451(a), effective 3/6/2017

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