64B16-28.820. Sterile Products and Special Parenteral/Enteral Compounding

(1) Sterile Products and Parenteral/Enteral Compounding.

(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.).

(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) Pharmacy Environment. 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 for the safe handling of drugs. The environment for this practice shall be set apart, and designed, and equipped to facilitate controlled aseptic conditions. Aseptic techniques shall prevail in this practice to minimize the possibility of microbial contamination.

(3) General Requirements.

(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.

(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. All such preparations shall include the time and/or date of expiration on the label. 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.

(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.

(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. The Policy and Procedure Manual shall include a Quality Assurance Program which monitors personnel qualifications, training and performance, equipment facilities, and random production sampling consistent with recommended standards for compounding and dispensing intravenous admixtures as set forth by the Joint Commission on Accreditation of Health Organizations, the National Coordinating Committee and Large Volume Parenteral, and as provided by the Florida Board of Pharmacy.

(e) Compounding shall be conducted within an annually certified laminar air flow (LAF) hood, except in the existence of a Class 100 certified compounding environment, or certified mobile isolation chamber, in which case compounding may be conducted without the use of a certified laminar air flow hood. All cytotoxins must be compounded in a certified vertical laminar air flow hood or certified mobile isolation chamber. The use of a Type A or Type B LAF hood used shall be dependent upon the volume of work anticipated. All certifications shall be performed following manufacturer specification.

(f) Protective garb: gloves, face and eye, and gowns should be provided and used.

(g) Proper aseptic procedures must be used at all times to prevent bacterial contamination of the product as well as chemical contamination of the operator.

(h) All unused cytotoxic agents and material must be disposed of properly in accordance with accepted professional standards and applicable law.

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

(a) Completed Board of Pharmacy permit application form (Form DPR/PH/107/9-88).

(b) Copy of Policy and Procedure Manual.

(c) Permit fee as provided in Rule 64B16-28.121, F.A.C.

(5) Minimum Requirements for Space, Equipment, Supplies and Publications.

(a) To ensure compliance with the general requirements as set forth, the following minimum requirements for space, equipment, supplies and publications shall be met by a pharmacy which operates under the special permit of a sterile products and parenteral/enteral compounding pharmacy. These requirements are in addition to the minimum requirements for space and equipment required of other types of pharmacies when applicable. The minimum permit requirements are set forth as follows:

(b) Space:

1. The area for preparing sterile prescriptions as provided for by this rule referred to as the sterile admixture room shall be set apart from general work and storage areas. The room shall be adequately air conditioned or shall be under positive pressure.

2. The sterile admixture room shall provide space for a minimum of one laminar flow hood. Additionally, the space shall be of adequate size to accommodate other equipment as provided herein and sufficient space to allow pharmacists and other employees working therein to adequately, safely, and accurately fulfill their duties related to prescriptions.

(c) Equipment:

1. Laminar Air Flow Hood(s):

a. Horizontal and/or.

b. Vertical.

2. Refrigerator/freezer convenient to the clean room.

3. Sink and wash area convenient to the clean room.

4. Appropriate waste containers for:

a. Used needles and syringes.

b. All cytotoxic waste including apparel.

(d) Supplies:

1. Gloves, masks and gowns.

2. Needles and syringes of various standard sizes.

3. Disinfectant cleaning agents.

4. Clean towels.

5. Handwashing materials with bactericidal properties.

6. Vacuum containers and various transfer sets.

7. “Spill kits” for cytotoxic agent spills.

(e) Current References:

1. Chapter 465, F.S.

2. Chapter 499, F.S.

3. Chapter 893, F.S.

4. Title 64B16, F.A.C., Rules of the Florida Board of Pharmacy.

5. United States Pharmacopeia and National Formulary, or Remington Pharmaceutical Sciences, or the United States Dispensatory (along with the latest supplements), or an equivalent thereof sufficient in scope to meet the professional practice needs of the pharmacy, and a current authoritative therapeutic reference.

6. Handbook of Injectable Drugs by American Society of Hospital Pharmacists.

7. “Practice Guidelines For Personnel Dealing With Cytotoxic Drugs.”

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.