Compounding Flashcards
Federal Law regulates the ________ and __________ of drugs
manufacture and distribution
difference between compounding and manufacturing
Traditional compounding is what pharmacists do at the pharmacy, making suspensions and topicals and other formulations, pursuant to a prescription for a patient. Manufacturing is when larger amounts are produced, usually commercially, and it is not patient specific
What act was passed in response to the meningitis tragedy?
Drug Quality and Security Act (DQSA)
The DQSA consists of these two acts
The Compounding Quality Act
*Covered in following slides in more detail
The Drug Supply Chain Security Act
*Requires an FDA regulated national “track and trace” system
*Drug products require bar codes so that they may be tracked throughout the drug supply chain
*Goal to prevent diversion and counterfeit drugs from entering the drug supply
64B16-32.001 Nonresident Pharmacy Permit
*Required before a pharmacy outside Florida can ship, mail, or deliver a dispensed medicinal drug into Florida
*Does not authorize the nonresident pharmacy to ship, mail, deliver, or dispense a compounded sterile product into Florida
64B16-32.005 Nonresident Pharmacies “Isolated Transactions”
A nonresident pharmacy is exempt from obtaining a nonresident pharmacy permit if the nonresident pharmacy limits its dispensing activity to a one time, per calendar year, isolated transaction
*
An isolated transaction is defined as making a one-time delivery of a dispensed medicinal drug(s)to a single identifiable patient in Florida
*
This exemption is not applicable to delivery of a dispensed medicinal drug that is a compounded sterile product
Pharmacies64B16-32.007
Nonresident Sterile Compounding Permit for Nonresident Pharmacies
This permit is required before a nonresident pharmacy ships, mails, delivers, or dispenses, in any manner, a patient-specific compounded sterile product into Florida
64B16-32.009
Nonresident Sterile Compounding Permit for an Outsourcing Facility
required before an outsourcing facility that is located outside of Florida, ships, mails, delivers, or dispenses, in any manner a compounded sterile product into Florida
64B16-32.011 Nonresident Sterile Compounding Permit – Mandatory Notification for Change in Pharmacy Name and PDM
shall be reported to the Board within 30 calendar days
*
Change in the name of the pharmacy or location, or both, department shall issue an updated permit; pay $25 fee
*
Notification required by this section shall be mailed to Florida Board of Pharmacy
64B16-32.013 Nonresident Sterile Compounding Permit – Change in Location or Ownership
Change in pharmacy location or change in pharmacy owner requires a new permit
64B16-32.015 Nonresident Sterile Compounding Permit Inspections and Approved Inspection Entities
All applicants and all permit holders seeking biennial renewal of their nonresident sterile compounding permit must have and present a current (within 6 months) and satisfactory (compliant with minimum standards) inspection (CSI) report
64B16-32.015 Nonresident Sterile Compounding Permit Inspections and Approved Inspection Entities
Registered Outsourcing Facility:
The minimum standards for a registered outsourcing facility are the Current Good Manufacturing Practices (cGMP)
Registered Nonresident Pharmacies: The minimum standards for a registered sterile compounding nonresident pharmacy are USP Chapters 797, 71, 85, and 731
USP 797 (Updated November 2023)
MINIMUM STANDARDS TO BE FOLLOWED WHEN PREPARING COMPOUNDED NONSTERILE PREPARATIONS (CNSPS) FOR HUMANS AND ANIMALS.
Non sterile compounding is
COMBINING, ADMIXING, DILUTING, POOLING, RECONSTITUTING OTHER THAN AS PROVIDED IN THE MANUFACTURER’S LABELING, OR OTHERWISE ALTERING A DRUG OR BULK DRUG SUBSTANCE TO CREATE A NONSTERILE MEDICATION.
These activities are not considered compounding
. Administration
. Nonsterile radiopharmaceuticals (USP 825)
. Reconstitution
. Repackaging
. Splitting tablets
Compounded non-sterile products that ARE SUBJECT to USP 795
. Solid/liquid oral
. Rectal/vaginal
. Topical
. Otic
. Nasa,/sinus
USP 795 requirements, minimize
1) excessive microbial contamination,
2) variability from the intended strength of correct ingredients (e.g., ±10% of the labeled strength),
3) physical and chemical incompatibilities,
4) chemical and physical contaminants, and/or
5) use of ingredients of inappropriate quality.
Designated person(s)
One or more individuals must be designated to be responsible and accountable for the performance, operations, personnel, and preparation of CNSPs.
Initial and refresher USP 795 training
Initial: hand hygiene, measuring/mixing, handling components, proper use of equipment, documentation
Refresher: Every 12 months. Must be documented
How often do CVEs and BSCs need to be certified?
At least every 12 months
All required compounding records for a particular CNSP (e.g., Master Formulation Record, Compounding Record, and release inspection and testing results) must be readily retrievable for how long after preparation?
at least 2 years or as required by the laws and regulations of the applicable regulatory jurisdiction, whichever is longer.
USP 797 (updated November 2023)
Pharmaceutical Compounding Sterile Preparations
Compounded Sterile Preparations (CSP) catergories
Cat 1: mixed in a PEC located in a segregated compounding area
Cat 2: mixed in a PEC located in the buffer room of a compounding suite
Cat 3: mixed in a PEC located in the buffer room of a compounding suite WITH SIGNIFICANT ADDITIONAL REQUIREMENTS FOR PERSONNEL REQUALIFICATION, FACULTY MONITORING, TESTING OF FINAL CSPs AND STERILE GARB (may have longer BUD that Cat. 2)
Immediate use CSPs BUD
Beyond use time is limited to no more than 4 hours from preparation.
