Compounding Flashcards
Is facility licensure required for non-sterile compounding?
No
Is facility licensure required for sterile compounding?
Yes
facility that compounds sterile drugs = outsourcing facility
All outsourcing facilities that compound sterile drugs in NYS shall be registered as an outsourcing facility under the FDC act
Dispensing/distribution regulations for outsourcing facilities in accordance with the FDC act:
- outsourcing facilities may NOT dispense or distribute drugs to any person pursuant to a prescription unless it is ALSO registered as a pharmacy
Outsourcing facility required documentation
Every 6 months must report to the executive secretary of the state board:
all drugs compounded in the 6 month period
- API
- Source
- NDC
- Strength of API
- Package description
- number of units produced
Restrictions on compounding without a prescription:
MUST be pursuant to a patient specific order
Exception: a pharmacy may compound limited quantities before receiving a valid Rx for an individual patient based on the history of the RPh receiving valid Rx orders for the compounding of the drug product
Beyond use dates of compounded products
No state specific regulations
Refer to USP
BUD USP 795 (non-sterile)
Non-preserved aqueous = 14 days
Preserved aqueous = 35 days
Nonaqueous dosage forms = 90 days
Solid dosage forms = 180 days
BUD USP 797 (sterile)
Category 1 [prepared in an unclassified segregated compounding area (SCA)]
- 12hrs or less at controlled room temp
- 24hrs or less in refrigerator
Category 2 [prepared in a cleanroom suite]
- all sterile starting components -> 4 days CRT, 10 days fridge, 45 days freezer
- one or more non-sterile starting component -> 1 day CRT, 4 days fridge, 45 days freezer
Certifications/licensure requirements for compounding
Must register as an outsourcing facility if sterile compounding
- must be overseen by a NYS licensed pharmacist
