21 NCAC 46 .1810. COMPOUNDING

In accordance with G.S. 90‑85.3(c) and (r), and 90‑85.6(a), the Board has primary jurisdiction over compounding occurring in locations holding a pharmacy permit, and such compounding shall comply with the following:

(1)           based on the existence of a practitioner‑pharmacist‑patient relationship and the presentation of a valid prescription, or in anticipation of prescription orders based on established prescribing patterns, a pharmacist may compound a drug product for an individual patient.  A pharmacist also may compound a drug product prior to receiving a valid prescription based on a history of receiving valid prescriptions generated within an established practitioner‑pharmacist‑patient relationship.  Compounded drug products shall not be offered to other entities for resale; however, practitioners may obtain compounded drug products to administer to patients within the scope of their professional practice;

(2)           the pharmacist is responsible for all aspects of compounding; however, unlicensed personnel working under the supervision of the pharmacist may assist in compounding;

(3)           drug substances used for compounding shall be USP or NF grade, or if unavailable, AR, CP, ACS, or FCC grade substances may be used.  If none of the foregoing grades are available, then the pharmacist must establish the purity and safety of the ingredient prior to its use.  Manufactured drug products used for ingredients must be labeled with a batch control number and a future expiration date;

(4)           equipment and utensils used for compounding shall not be reactive, additive or absorptive so that the safety, identity, strength, quality, and purity of the compounded drug product will not be adversely affected.  All compounding equipment and utensils shall be cleaned and sanitized prior to use.  A compounding pharmacy shall have written procedures and formulas for the compounding of drug products;

(5)           any excess compounded drug product retained by the pharmacy shall be labeled with a complete list of ingredients or reference to such information, the preparation date, and an expiration date based upon the pharmacist's professional judgment.  The excess compounded drug product shall be stored under conditions to preserve its strength, quality and purity;

(6)           with the exception of the simple reconstitution of drug products, the pharmacy shall maintain a log showing the name or initials of the person who compounded a drug product and the name or initials of the pharmacist who checked the compounded drug product;

(7)           with the exception of the simple reconstitution of drug products, the pharmacy shall maintain a recordkeeping system from which the date of purchase, supplier, manufacturer, and lot number or other identifier of each ingredient can be determined for each compounded drug product dispensed; provided however, that health care facility pharmacies may comply with this requirement by maintaining records of lot numbers only.  All pharmacy records resulting from compounding, including the compounding log, shall be readily retrievable and maintained in the pharmacy for a period of three years;

(8)           in addition to the requirements of this Section, the compounding of radiopharmaceutical drug products shall comply with Section .2700 of this Chapter;

(9)           in addition to the requirements of this Section, the compounding of sterile parenteral drug products shall comply with Section .2800 of this Chapter.

 

History Note:        Authority G.S. 90-85.6; 90-85.32;

Eff. September 1, 1995;

Amended Eff. August 1, 1998.