Labeling

(1) At the time of dispensing of the sterile product, the dispensing container must bear a label which contains the following information: (a) Patient's name (if for outpatient use) or healthcare entity name; (b) Prescriber(s) name (if for outpatient use); (c) Pharmacy practice site name, address, and phone number (if for outpatient use); (d) Identification of the pharmacist who compounded the sterile product; (e) When applicable, identification of the pharmacy intern or pharmacy technician who assisted in the compounding of the sterile product; (f) Name and amount of drug added; (g) Expiration date and, when applicable, expiration time, Beyond Use Dating (BUD); (h) Date of compounding; (i) Appropriate auxiliary label(s); and (j) Directions for use (if for outpatient), if applicable. (2) Original medical or prescription orders for sterile products shall comply with applicable state and federal laws and regulations.