NAC639.67017. Use of automated compounding devices.

     1. A pharmacy may use an automated compounding device to:

     (a) Assist with the compounding of a drug product; or

     (b) Produce a final compounded drug product.

     2. If a pharmacy uses an automated compounding device as described in subsection 1, the pharmacy shall establish and maintain written policies and procedures, in addition to the policies and procedures established and maintained pursuant to NAC 639.67015, that address:

     (a) The qualifications that a pharmacist or a pharmaceutical technician must have to use the automated compounding device;

     (b) The routine maintenance and cleaning required to be performed on the automated compounding device which, at a minimum, satisfies the requirements for maintenance and cleaning established by the manufacturer of the automated compounding device; and

     (c) The testing required to be performed on the automated compounding device to ensure that the automated compounding device is measuring and dispensing the components of the compounded drug product and manufacturing the final compounded drug product within tolerances of not more than plus or minus 5 percent.

     3. If a pharmacy uses an automated compounding device to assist with the compounding of a drug product for parenteral nutrition, the pharmacy shall establish safe maximum limits for each additive that may be used in compounding such a drug product. The pharmacy shall ensure that:

     (a) The automated compounding device will cease compounding the drug product for parenteral nutrition if a maximum limit for an additive will be exceeded until a pharmacist, after consultation with the prescribing practitioner, makes changes to or validates the correctness of the prescription or chart order; or

     (b) If an automated compounding device cannot be programmed to cease the compounding process as described in paragraph (a):

          (1) The automated compounding device is equipped with an audible alarm or some other mechanism that will alert the pharmacist if a maximum limit for an additive has been exceeded; and

          (2) The pharmacy has written policies and procedures to prevent the continuation of the compounding process once a maximum limit for an additive has been exceeded until a pharmacist, after consultation with the prescribing practitioner, makes changes to or validates the correctness of the prescription or chart order.

     4. If the pharmacy uses a computerized order entry system in conjunction with the automated compounding device, the pharmacy must ensure that the computerized order entry system will cease processing the order if a maximum limit for an additive will be exceeded until a pharmacist, after consultation with the prescribing practitioner, makes changes to or validates the correctness of the prescription or chart order.

     5. A pharmacy shall make and maintain records that evidence compliance by the pharmacy with the policies and procedures required by this section.

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