1. (1) Sterile Products and Parenteral/Enteral Compounding.

   1. (a) A sterile products and parenteral/enteral compounding pharmacy is a type of special pharmacy as provided by Section 465.0196, F.S., which is limited in scope of pharmacy practice to render sterile products and parenteral/enteral compounding functions. This pharmacy practice facilitates the utilization of certain institutional therapeutic measures by patients in the home environment or by patients in an institutional environment where such pharmacy service is unavailable. Pharmacy services, sterile products and parenteral/enteral products provided by a special sterile products and parenteral/enteral compounding pharmacy pursuant to prescription as defined by Section 465.003(13), F.S., shall be limited to the compounding and/or dispensing of:

      1. Sterile preparations for parenteral therapy, parenteral nutrition; and/or

      2. Sterile preparations for jejunostomy feeding and sterile irrigation solutions; and/or

      3. Sterile preparations of cytotoxic or antineo-plastic agents; and/or

      4. Sterile products (i.e., injectables, eye drops, etc.).

   2. (b) Prior to engaging in a sterile products and parenteral/enteral compounding pharmacy practice an entity shall obtain a special sterile products and parenteral/enteral compounding pharmacy permit as provided herein.
2. (2) The compounding and dispensing of sterile products and parenteral/enteral prescription preparations within a special sterile products and parenteral/enteral compounding pharmacy shall be accomplished in a pharmacy environment subject to the pharmacy permit laws of this state and in accordance with those requirements set forth in Rule 64B16-27.797, F.A.C., The Standards of Practice for Compounding Sterile Products.

3. (3) General Requirements.

   1. (a) A special sterile products and parenteral/enteral compounding pharmacy shall be under the control and supervision of a licensed pharmacist, who shall be designated prescription department manager on the application for a special sterile products and parenteral/enteral compounding pharmacy. The prescription department manager or other licensed qualified pharmacist as provided herein shall be present on duty during all hours of operation of said pharmacy. Changes in prescription department manager shall be reported to the Board of Pharmacy office within 10 days by the permit holder and prescription department manager of record. A prescription department manager of a special sterile products and parenteral/enteral compounding pharmacy shall not be designated prescription department manager of record of more than one special sterile products and parenteral/enteral compounding pharmacy, unless otherwise approved by the Board. The Board will consider the proximity of the facility as well as the administrative workload created by the two permits, in determining whether or not it will approve the designation of someone as a prescription department manager of more than one special sterile products and parenteral/enteral compounding pharmacy.
   2. (b) A special sterile products and parenteral/enteral compounding pharmacy shall provide special handling and packaging of compounded parenteral and enteral preparations when delivering from the pharmacy to the patient or institution as required to maintain stability of the preparations. Delivery from the pharmacy to the patient shall be made within a reasonable time. A special sterile products and parenteral/enteral compounding pharmacy shall provide telephone accessibility to its pharmacist(s) for its patients at all hours.
   3. (c) A patient profile shall be maintained for each patient. The profile must contain available medical information consistent with prevailing pharmacy standards which shall be confidential.
   4. (d) A Policy and Procedure Manual shall be prepared and maintained at each special sterile products and parenteral/enteral compounding pharmacy, and be available for inspection by authorized agents of the Board of Pharmacy and the Department. The Policy and Procedure Manual shall set forth in detail the objectives and operational guidelines of the permittee.

4. (4) An applicant for a special sterile products and parenteral/enteral compounding pharmacy permit shall provide the Board of Pharmacy with the following:

   1. (a) Completed Board of Pharmacy permit application form (Form DH MQA 1220 01/2018), incorporated in Rule 64B16-28.100, F.A.C.
   2. (b) Copy of Policy and Procedure Manual.
   3. (c) Permit fee as provided in Rule 64B16-26.1022, F.A.C.

5. (5) The pharmacy shall have access to the following Current Published References:

   1. (a) Chapter 465, F.S.
   2. (b) Chapter 499, F.S.
   3. (c) Chapter 893, F.S.
   4. (d) Division 64B16, F.A.C., Rules of the Florida Board of Pharmacy.
   5. (e) United States Pharmacopeia and National Formulary, or Remington Pharmaceutical Sciences, or the United States Dispensatory (along with the latest supplements), or The Handbook of Injectable drugs by the American Society of Health Systems Pharmacy or an equivalent thereof sufficient in scope to meet the professional practice needs of the pharmacy, and a current authoritative therapeutic reference.

Rulemaking Authority 465.005, 465.022 FS. Law Implemented 465.018, 456.0196 FS. History–New 4-26-84, Formerly 21S-1.40, Amended 7-27-86, Formerly 21S-1.040, Amended 7-31-91, 10-14-91, Formerly 21S-28.820, 61F10-28.820, Amended 3-11-96, 6-4-97, Formerly 59X-28.820, Amended 7-1-02, 1-29-03, 6-4-14, 9-23-25.