1. A. The pharmacist shall ensure that the portable drug kit:

   1. (1) Is sealed with a tamper evident tag or other means for detecting entry to the kit;

   2. (2) Displays on the outside of the kit:

      1. (a) A serial number unique to the kit;
      2. (b) An expiration date which reflects the earliest expiration date of any item contained in the kit;
      3. (c) The contents of the kit;
      4. (d) That the contents are or are not sterile;
      5. (e) The legend “To be returned to the pharmacy within 5 days of breaking seal, with a completed administration record or prescription enclosed”; and
      6. (f) Storage requirements for the contents;

   3. (3) Contains:

      1. (a) Only prescription drugs and nonprescription items approved for the kit by a committee as defined in Regulation .01B(1) of this chapter;
      2. (b) A temperature monitor to indicate maintenance of proper storage conditions; and

      3. (c) A written administration record to be completed by the licensed health care provider using the kit, which includes the administration record indicating:

         1. (i) The name of the patient,
         2. (ii) The name of the prescriber,
         3. (iii) Drug name, form, and dosage,
         4. (iv) Date the drug was used or wasted,
         5. (v) The reason for administration or wastage of the drug, and
         6. (vi) The name of the licensed health care provider utilizing the kit;
   4. (4) Displays or includes written information inside the kit listing contraindications to use of the kit; and
   5. (5) Does not contain a controlled dangerous substance.
2. B. A pharmacist shall only distribute a portable drug kit which complies with the requirements of this chapter.

Authority: Health Occupations Article, §12-205, Annotated Code of Maryland

Effective date: September 6, 1999 (26:18 Md. R. 1376)

Regulations .01—.04 amended effective April 16, 2001 (28:7 Md. R. 690)

Regulations .05 and.06 adopted effective April 16, 2001 (28:7 Md. R. 690)