Compounding

Question 1

Federal Law regulates the ________ and __________ of drugs

Answer 1

manufacture and distribution

Question 2

difference between compounding and manufacturing

Answer 2

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

Question 3

What act was passed in response to the meningitis tragedy?

Answer 3

Drug Quality and Security Act (DQSA)

Question 4

The DQSA consists of these two acts

Answer 4

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

Question 5

64B16-32.001 Nonresident Pharmacy Permit

Answer 5

*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

Question 6

64B16-32.005 Nonresident Pharmacies “Isolated Transactions”

Answer 6

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

Question 7

Pharmacies64B16-32.007
Nonresident Sterile Compounding Permit for Nonresident Pharmacies

Answer 7

This permit is required before a nonresident pharmacy ships, mails, delivers, or dispenses, in any manner, a patient-specific compounded sterile product into Florida

Question 8

64B16-32.009
Nonresident Sterile Compounding Permit for an Outsourcing Facility

Answer 8

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

Question 9

64B16-32.011 Nonresident Sterile Compounding Permit – Mandatory Notification for Change in Pharmacy Name and PDM

Answer 9

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

Question 10

64B16-32.013 Nonresident Sterile Compounding Permit – Change in Location or Ownership

Answer 10

Change in pharmacy location or change in pharmacy owner requires a new permit

Question 11

64B16-32.015 Nonresident Sterile Compounding Permit Inspections and Approved Inspection Entities

Answer 11

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

Question 12

64B16-32.015 Nonresident Sterile Compounding Permit Inspections and Approved Inspection Entities

Answer 12

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

Question 13

USP 797 (Updated November 2023)

Answer 13

MINIMUM STANDARDS TO BE FOLLOWED WHEN PREPARING COMPOUNDED NONSTERILE PREPARATIONS (CNSPS) FOR HUMANS AND ANIMALS.

Question 14

Non sterile compounding is

Answer 14

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.

Question 15

These activities are not considered compounding

Answer 15

. Administration
. Nonsterile radiopharmaceuticals (USP 825)
. Reconstitution
. Repackaging
. Splitting tablets

Question 16

Compounded non-sterile products that ARE SUBJECT to USP 795

Answer 16

. Solid/liquid oral
. Rectal/vaginal
. Topical
. Otic
. Nasa,/sinus

Question 17

USP 795 requirements, minimize

Answer 17

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.

Question 18

Designated person(s)

Answer 18

One or more individuals must be designated to be responsible and accountable for the performance, operations, personnel, and preparation of CNSPs.

Question 19

Initial and refresher USP 795 training

Answer 19

Initial: hand hygiene, measuring/mixing, handling components, proper use of equipment, documentation
Refresher: Every 12 months. Must be documented

Question 20

How often do CVEs and BSCs need to be certified?

Answer 20

At least every 12 months

Question 21

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?

Answer 21

at least 2 years or as required by the laws and regulations of the applicable regulatory jurisdiction, whichever is longer.

Question 22

USP 797 (updated November 2023)

Answer 22

Pharmaceutical Compounding Sterile Preparations

Question 23

Compounded Sterile Preparations (CSP) catergories

Answer 23

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)

Question 24

Immediate use CSPs BUD

Answer 24

Beyond use time is limited to no more than 4 hours from preparation.