Published on: 15777358. 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 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.
Published on: 13977620. Mark Schneider, on behalf of TeamCare Infusion Orlando, Inc. and TeamCare Infusion, Inc., seeking a variance or waiver of Rule 64B16-28.820(1)(a), Florida Administrative Code, asking to allow petitioner to also engage in non-sterile compounding without the necessity to obtain a community pharmacy permit. The Board will address the Petition at its next scheduled meeting.
Comments on this petition should be filed with the Board of Pharmacy, 4052 Bald Cypress Way, Bin C04, Tallahassee, Florida 32399-3254., within 14 days of publication of this notice.
Published on: 7561264. The Board proposes the rule amendment in order to make corrections; for consideration of hour and day requirement; for clarification of language; for consideration of requirements; to add application; to add specific application information; to add application; to clarify language; and to review the existing language in the rules to determine whether other changes are necessary.
Published on: 7560779. The Board proposes the rule amendment and for a substantial re-write and reorganization of the Chapter; and to review the existing language in the rules to determine whether changes are necessary.