The compounding of preparations will include the following activities by the Pharmacy: verification of the source of raw materials to be used; compliance with applicable United States Pharmacopoela guidelines (including testing requirements), the Health Insurance Portability and Accountability Act of 1996, and all applicable competency and accrediting standards as determined by the Colorado State Board of Pharmacy as well as the Board of Pharmacy in the Practice's state residence. Pharmacy agrees to record the lot numbers of compounded preparation supplied for office use so that, in the event a recall of the preparation is required, Pharmacy shall notify Physician of the recall and can facilitate contacting any patients who received the product. In such an event, Pharmacy's existing protocols for notifying patients, quarantine of the product (if applicable), and/or recall will be followed
Any adverse reactions or complaints may be submitted by the patient to either Pharmacy or Physician; in the event a report is made, the entity receiving the report will forward a copy to the other entity. If patient harm is suspected or confirmed to be due to a preparation compounded by Pharmacy, Pharmacy will notify the Colorado State Board of Pharmacy, the Board of Pharmacy where the patient resides, and the FDA.