64B16-28.850. Special Pharmacy - ESRD

(1) An ESRD Pharmacy is a type of special pharmacy as provided by Section 465.0196, F.S., which is limited in scope of pharmacy practice to the provision of dialysis products and supplies to persons with chronic kidney failure for self-administration at the person’s home or specified address. Pharmacy services and dialysis supplies and products provided by an ESRD pharmacy shall be limited to the distribution and delivery of legend drugs included in schedule (3) below; or legend devices included in schedule (4) below; which are ordered by a physician for administration or delivery to a person with chronic kidney failure for self-administration at the person’s home or specified address. All dialysis supplies and products provided by an ESRD pharmacy shall be prepackaged and shall be covered by an approved NDA or 510 (k) application issued by the Federal Food and Drug Administration.

(2) Prior to engaging in an ESRD pharmacy practice an entity shall obtain a special ESRD pharmacy permit as provided herein.

(3) Schedule of legend drugs:

(a) Saline Solutions.

(b) Porcine Heparin.

(c) Beef Heparin.

(d) Dextrose Solutions.

(e) Doxercalciferol.

(f) Epoetin Alfa.

(g) NACL INJ 50 MEQ/20 ML.

(h) Levocarnitine.

(i) Lidocaine.

(j) Vitamin Preparations (dialysate use only).

(k) Paricalcitrol.

(l) Peritoneal Dialysate Solutions.

(m) Protamine Sulfate.

(n) Potassium 20 MEQ/10ML (dialysate use only).

(o) Sodium Ferric Gluconate Complex or equivalent.

(p) Sterile Water for Irrigation.

(4) The schedule of legend devices includes:

(a) Hemodialyzers.

(b) Hemodialysis solutions.

(c) Bloodlines and Associated Connectology.

(d) Peritoneal Dialysis Tubing and Connectology.

(5) The provision of legend drugs and devices included in the schedule necessary to perform dialysis to a person with chronic kidney failure for self-administration at the person’s home or specified address shall be under the professional supervision of an appropriate practitioner licensed under Florida law. The consultant pharmacist shall assure that the following occurs:

(a) The ESRD pharmacy receives a prescription from the prescribing practitioner directing the pharmacist to dispense and deliver to a person with chronic kidney failure (or such person’s designee) any legend drugs and/or devices included in the formulary necessary for the self-administration of dialysis at such person’s home or specified address.

(b) That no dispensing shall occur unless the person with chronic kidney failure has been trained in the proper use and administration of such products. Further, the consulting pharmacist shall ensure that the ESRD pharmacy has received records confirming the completion of such training.

(c) After the delivery of such products by the ESRD pharmacy, the ESRD pharmacy shall upon request therefor, make available to the prescribing practitioner documentation describing, in sufficient detail, the types and quantities of products dispensed and delivered by the ESRD pharmacy. The ESRD pharmacy shall also, upon request, make available to the prescribing practitioner documentation confirming shipment of such products and receipt thereof by the person with chronic kidney failure.

(6) The licensed ESRD pharmacy shall comply with all applicable state and federal regulatory requirements and shall maintain in effect all applicable permits and licenses required to dispense and deliver legend drugs and/or devices included in the formulary described in this Section.

(7) The ESRD pharmacy shall deliver products to a person with chronic kidney failure only upon receipt of a valid prescription from a prescribing practitioner specifying or including:

(a) Documentation that the intended recipient of the products has been trained in home dialysis therapy and will require such products;

(b) The duration of prescribing practitioner’s order; and

(c) The name and product code of each product prescribed and the quantity prescribed.

(d) The prescription may indicate the person with chronic kidney failure shall have the right to request refills of legend drugs, devices or both, included in the schedule and described in the order for a period of one year.

(8) The ESRD pharmacy shall assemble the products to be delivered pursuant to the prescribing practitioner’s prescription. In assembling such products for delivery, the ESRD pharmacy shall take steps necessary to assure the following:

(a) The code numbers and quantities of the products assembled match the code numbers identified in the prescribing practitioner’s prescription;

(b) With respect to any dated products, a minimum of three (3) full months of shelf-life remain; and

(c) All cartons and other packaging are properly labeled as noted below:

1. “Use as Directed” statement;

2. The name and address of the person to whom the products will be delivered;

3. The name of the prescribing practitioner;

4. The name and address of the ESRD pharmacy location from which the products were shipped;

5. The prescription number identifying the shipment to the order created by the prescribing practitioner; and

6. Any special instructions regarding delivery dates or locations.

7. The date after which the drug(s) and/or device(s) must be discarded. Notwithstanding any other rule, the ESRD pharmacy may use, in lieu of a discard after date, the manufactures expiration date when such is displayed in an unopened sealed package.

(d) All cartons and related packaging shall be visually inspected to confirm compliance with the specifications in paragraph (8)(c). Compliance with the requirements set forth in paragraph (8)(c) shall be conducted by the consulting pharmacist or independently by not less than two employees of the ESRD pharmacy trained in the performance of the foregoing activities, each of whom shall acknowledge in writing their completion of such activities with respect to each group of products assembled for delivery.

(9) The ESRD pharmacy permit holder shall assure through visual inspection and comparison of records that products assembled for delivery to persons with chronic kidney failure are consistent with the prescribing practitioner’s order therefor.

(10) The products ordered by the prescribing practitioner under this Rule shall be delivered by either the ESRD pharmacy or a carrier authorized by the ESRD pharmacy.

(11) Upon delivery of the products by the ESRD pharmacy or its carrier to the person identified on the prescribing practitioner’s order, the ESRD pharmacy or its carrier shall confirm receipt by the patient or the patient’s designee that the number of units delivered equals the number of units identified on the appropriate documentation. Compliance with the foregoing requirements set forth above shall be conducted by an employee or agent of the ESRD pharmacy trained in the performance of such activities, who shall acknowledge in writing the delivery of the products and the completion of such activities with respect to each delivery.

(12) In addition to the foregoing operation requirements, an ESRD pharmacy shall comply with the following:

(a) The ESRD pharmacy license shall be displayed at each ESRD pharmacy location.

(b) The Board of Pharmacy shall be notified in writing of the Consulting Pharmacist responsible, at the time of application for the permit, for supervising the ESRD pharmacy operations and within 10 days, if the Consultant Pharmacist of record changes.

(c) The ESRD pharmacy’s hours of business shall be posted. The ESRD pharmacy shall be open such hours as are necessary to safely and effectively dispense and deliver supplies to those persons designated by the applicable prescribing practitioner. An ESRD pharmacy shall provide twenty-four hour emergency and on-call service.

(d) The ESRD pharmacy shall have sufficient space and storage capabilities as are necessary to carry out its operation.

(e) All legend drugs and/or legend devices included in the formulary subject to this Rule shall be properly identified.

(f) The ESRD pharmacy shall maintain a current copy of the Florida pharmacy laws and rules.

(g) The ESRD pharmacy shall comply with patient counseling requirements of Rules 64B16-27.800-.810 and 64B16-27.820, F.A.C.

(13) ESRD Pharmacy Application Requirements. An applicant for an ESRD pharmacy permit shall provide the Board of Pharmacy with a Policy and Procedure Manual setting forth in detail the operational guidelines of the applicant. The Policy and Procedure Manual shall include a Quality Assurance Program which monitors personnel qualifications, training and performance.

(14) An ESRD pharmacy shall be under the control and supervision of licensed Consultant Pharmacist licensed under Section 465.0125, F.S. The Consulting Pharmacist shall be responsible for the drug/device delivery system.

(15) The Consultant Pharmacist of record for the ESRD Pharmacy shall be responsible for establishing a written protocol and Policy and Procedure Manual for the implementation of a delivery system to be utilized in compliance with the requirements of this Rule.

(16) The Consultant Pharmacist shall inspect the permitted ESRD pharmacy on a monthly basis.

(17) A copy of the ESRD pharmacy’s Policy and Procedure Manual as provided above shall accompany the permit application, shall be kept within the ESRD Pharmacy, and shall be available for inspection by the Department of Health. Changes in the Policy and Procedure Manual shall be approved by the Consulting Pharmacist.

Specific Authority 465.005, 465.0125 FS. Law Implemented 465.0196, 465.022 FS. History–New 10-2-94, Formerly 59X-28.850, Amended 9-20-99, 7-17-05, 6-24-08.