Exam (elaborations)
Florida Rules Part II questions and answers verified for accuracy
- Module
- FLORIDA ASSISTED LIVING
- Institution
- Oxford University (OX)
Florida Rules Part II questions and answers verified for accuracy
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Florida Rules Part II questions andanswers verified for accuracy
Definition of Compounding - answer 1. Preparation of drugs or devices in anticipation of
prescription based on routine, regularly observed prescribing patterns
2. Preparation pursuant to a prescription of drugs or devices which are not commercially
available
3. Preparation of commercially available products from bulk when the prescribing practitioner
has prescribed the compounded product on a per prescription basis and the patient has been
made aware of the compounding pharmacist
The legal definition of manufacturing - answer The preparation of drugs or devices for the sale
or transfer to pharmacies, practitioners, or entities for purposes of dispensing or distribution is
not compounding
Pharmacies that manufacture compounds for sale or transfer must be registered as what? -
answer Outsourcing facilities
Can traditional pharmacies compound for office use? - answer NO, the pharmacy must register
as an outsourcing facility to compound for office use
How long do pharmacies have to maintain records for all compounded drugs ordered for office
use? - answer They have to be readily retrievable for at least 4 years
Office use labels need to contain: - answer 1. name, address, and phone number of the
compounding pharmacy
2. Name and Strength of the preparation of a list of active ingredients and strengths
3. Pharmacy lot # and BUD
4. The quantity or amount in the container
,5. The appropriate ancillary instructions such as storage instructions, cautionary statements, or
hazardous drug warning labels were appropriate
6. the statement "For Institutional or Office Use Only - Not for Resale" or if the drug is provided
to a veterinarian the statement "compounded drug"
All sterile compounding in Florida must be done according to the minimum requirements of: -
answer USP Chapter 797, 71, 85, 731, 795, and 800
Lyophilization: standard of practice for compounding sterile products - answer USP Chapter 797
Compounded sterile products prepared for lyophilization shall be maintained in ISO 5
unidirectional laminar flow air, smoke studies shall be conducted, smoke study has to be
recorded and available for inspection
documentation of cleaning has to be documented and ready for inspection
Chapter 71 is apart of the validation study
A glove fingertip test is done for Lyophilization? - answer with each batch after the fill and
transport of the vials.
Exceptions to USP Sterile Compounding Preparation requirements under Florida Law: - answer
1. Gloves can be worn after entering the ante room
2. The closed system transfer devices can be used if you are making low volumes (less than 40
doses per month)
3. Pharmacies that are able to maintain ISO standards do not need to update their supply air or
filter/ducts to USP standards.
4. USP 797 wants ceiling tiles to be caulked, hydrophobic and impervious but you do not have to
do this if: 1) they meet ISO 7 or better 2) the tiles are sealed front and back so they are
hydrophobic and impervious 3) tiles are in a gasket gird sealing system
, Chemotherapy Compounding general rules from 797 - answer Vertical flow class II hoods,
PPE, written procedures for handling spills in place, prepared doses of anti-neoplastic need to
be labeled, stored, and shipped appropriate
Compounding RecordKeeping Requirements - answer A written record MUST be maintained for
each batch of a compounding product
What will compounding records contain? (8) - answer 1. Date of compounding
2. Traceable control number (manufacturer lot # or a # assigned by pharmacist)
3. Complete formula maintained and readily retrievable (equipment and method)
4. Pharmacist & technician signature or initials
5. manufacturer or materials
6. quantity in units of finished products
7. package size and # of units prepared
8. Name of patient who received product
Standards for Approval of Registered Pharmacy Technician Training Programs - answer To be
registered as a pharmacy technician in Florida, an applicant must have completed a Board
approved pharmacy technician training program
Preapproved Pharmacy Technician Training Programs of note - answer PTAC
ACPE
ASHP
SACS
Requirements for Patient Records - answer Records must be immediately retrievable &
1. Full name of patient, address, telephone # and age/DOB and gender
2. List of ALL new and refill Rx over the last 4 years showing name of drug or device, rx number,
name/strength, and quantity, date received, prescriber
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