1. (a) Drugs shall be prepackaged in quantities suitable for internal distribution only by a pharmacist, licensed advanced pharmacy technician, or by supportive personnel under the direct supervision of a pharmacist.

2. (b) The label of a prepackaged unit shall indicate the:

   1. (1) Name and strength of the drug and name of the manufacturer, manufacturers lot number, or distributor;
   2. (2) Assigned in‑house, quality control lot number;
   3. (3) Expiration date; and
   4. (4) Quantity of the drug, if the quantity is greater than one.

3. (c) The pharmacist or licensed advanced pharmacy technician who prepackages or supervises prepackaging shall maintain a written or electronic record that contains at least the following information:

   1. (1) Name of the drug, strength, and dosage form;
   2. (2) Assigned in-house, quality control lot number;
   3. (3) Manufacturer or distributor;
   4. (4) Manufacturer's lot number;
   5. (5) Expiration date;
   6. (6) Quantity per prepackaged unit;
   7. (7) Number of prepackaged units;
   8. (8) Date packaged;
   9. (9) Identifier of the prepacker; and
   10. (10) Signature of the responsible pharmacist or licensed advanced pharmacy technician.
4. (d) Stock packages, repackaged units, and control records shall be quarantined together until checked/released by the pharmacist.

Source. #1639, eff 11-1-80; ss by #2260, eff 1-5-83; ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff 9-21-95, EXPIRED, 1-19-96 New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04 New. #8316, eff 3-26-05, EXPIRED: 3-26-13 New. #10903, eff 8-5-15; ss by 13398, eff 6-22-22 (formerly Ph 703.02)