variance or waiver filed by Robert Haghgou, Pharm.D., on behalf of Care America Pharmacy Services, seeking a waiver of the requirement of Rule 64B16-28.820(1)(a), which provides that a sterile products and parenteral/enteral compounding pharmacy is ...

 

DEPARTMENT OF HEALTH

Board of Pharmacy

RULE NO.RULE TITLE:

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

NOTICE IS HEREBY GIVEN that on March 10, 2015, the Board of Pharmacy, received a petition for variance or waiver filed by Robert Haghgou, Pharm.D., on behalf of Care America Pharmacy Services, seeking a waiver of the requirement of paragraph 64B16-28.820(1)(a), which provides that 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.).

Petitioner is seeking a variance of waiver of the rule to be allowed to compound Non-Sterile medicines.

A copy of the Petition for Variance or Waiver may be obtained by contacting: Allison Dudley, Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin #C04, Tallahassee, Florida 32399-3254 or at [e-mail]. Comments on this petition should be filed with the Board of Pharmacy/MQA, within 14 days of publication of this notice.