NAC639.67053. Tests for competency and proficiency of certain pharmaceutical personnel.

     1. Except as otherwise provided in subsections 4 and 5, a pharmacy engaged in the practice of compounding and dispensing sterile compounded drug products shall require each pharmacist and pharmaceutical technician who compounds sterile compounded drug products to pass a media fill test which must be conducted in the manner provided by chapter 797 of the United States Pharmacopeia - National Formulary, as adopted by reference in paragraph (c) of subsection 1 of NAC 639.670, and which must be commensurate to the highest level of risk of compounding sterile compounded drug products that the pharmacist or pharmaceutical technician will be authorized by the pharmacy to perform:

     (a) Before the pharmacy authorizes the pharmacist or pharmaceutical technician to compound a sterile compounded drug product that will be administered or dispensed to a patient;

     (b) At least once each year thereafter if the pharmacy authorizes the pharmacist or pharmaceutical technician to compound low-risk sterile compounded drug products or medium-risk sterile compounded drug products; and

     (c) At least twice each year thereafter if the pharmacy authorizes the pharmacist or pharmaceutical technician to compound high-risk sterile compounded drug products.

     2. A pharmacy engaged in the practice of compounding and dispensing sterile compounded drug products shall ensure the competency and proficiency of each pharmacist and pharmaceutical technician at the highest level of risk of compounding sterile compounded drug products the pharmacist or pharmaceutical technician is authorized by the pharmacy to perform by:

     (a) Requiring the pharmacist or pharmaceutical technician to provide a sample for a gloved fingertip sampling which must be conducted in the manner provided by chapter 797 of the United States Pharmacopeia - National Formulary, as adopted by reference in paragraph (c) of subsection 1 of NAC 639.670;

     (b) Testing a sample taken from a surface cleaned by the pharmacist or pharmaceutical technician to determine sterility;

     (c) Ensuring the pharmacist or pharmaceutical technician receives, on an ongoing basis, sufficient training to maintain that competency and proficiency through attending in-house training programs or continuing education courses;

     (d) Observing the pharmacist or pharmaceutical technician as he or she compounds sterile compounded drug products; or

     (e) Correcting any error and initiating remedial measures for a pharmacist or pharmaceutical technician to take after an error has been noted with a sterile compounded drug product that was made or verified by the pharmacist or pharmaceutical technician.

     3. A pharmacy shall make and maintain records concerning all the actions listed in subsection 2 which the pharmacy takes to ensure the competency and proficiency of each pharmacist and pharmaceutical technician who is authorized by the pharmacy to compound sterile compounded drug products.

     4. A sterile compounded drug product that is compounded by a pharmacist or pharmaceutical technician who has not passed the media fill test required by paragraph (a) of subsection 1 may be dispensed and administered to a patient if:

     (a) The managing pharmacist of the pharmacy determines that it is appropriate to dispense and administer the sterile compounded drug product; and

     (b) The entire compounding process was personally witnessed by a pharmacist or pharmaceutical technician who passed the media fill test.

     5. A pharmacy is not required to make a pharmacist or pharmaceutical technician pass a media fill test pursuant to paragraph (a) of subsection 1 if the pharmacist or pharmaceutical technician provides evidence of passing a media fill test:

     (a) Within the immediately preceding 9 months if the pharmacist or pharmaceutical technician will compound low-risk sterile compounded drug products and medium-risk sterile compounded products; or

     (b) Within the immediately preceding 5 months if the pharmacist or pharmaceutical technician will compound high-risk sterile compounded drug products.

     (Added to NAC by Bd. of Pharmacy by R035-06, eff. 9-18-2008)