Compounding

Question 1

Is Facility Licensure Required for General Compounding? Sterile Compounding?

Answer 1

Outsourcing Facilities:
* Must obtain license if providing non-patient-specific compounded human drugs
* Must obtain IA Controlled Substance Act Registration if providing controlled substances

$400 Application/Renewal Fee: Renews Annually on January 1st (Renewal Period Nov 1st-Dec 31st)
* Must contain pharmacy, ownership, and PIC information
* Verfication PIC has valid license + background check + read and understands sterile compounding laws & regulations
* Submit posession of valid FDA Registration as an Outsourcing Facility
* Submit evidence of satisfactory inspections by Home State Regulatory Authority (or another board approved inspection)
* Submit evidence if 1+ FDA inspection has occured in the last 5 years before that date of application
* License = Deliquent on Jan 1st

Reactivation Grace Period (Jan 31st):
* $400 Late Fee (+ $400 App Fee)
* App Postmarked/Delivered By 1/31
* NO Disciplinary Action for Providing Patient Care in Month of January

Reactivation Fee After Grace:
* After 1/31: $1,600 (+ $400 App Fee)
* App Must Contain Jan Patient Care
* Subject to Board Disciplinary Action for Providing Patient Care

Question 2

Restrictions on Compounding w/o Rx?

Answer 2

Must be a Patient-Specific Prescription (unless distributed for office/hospital use)

Veterinary Compounding Preparations: May be sold directly to practitioner, pharmacy, or outsourcing facility.

• Sold to practitioner for office use: may be dispensed to the owner of veterinary patient for emergency use as long as the supply does not exceed 14 days. (Must treat immediate medical need when timely access to compounded medications are not available, no commercially available product can meet need of patient, and lack of treatment will likely result in harm.)

Question 3

Stability of Compounded Product?

Answer 3

Not Specified Other Than Flavoring Agents:
* Labeled Beyond-Use Date: Cannot exceed 14 days if drug is stored in the fridge and a flavoring agent is added.
* A different beyond-use date may be used if supported by peer-reviewed medical literature.

Question 4

Manufacturer License Required for Compounding?
Special Volume Requirements?
Reporting?

Answer 4

Volume/Manufacturer Requirements: Not Specified

Reporting:
* Report compound data to NABP information sharing network no later than April 1, 2022 an annually thereafter.

Compounding Data May Include the Following if Pharmacy Engaged in Following Activities:
* Sterile/Nonsterile Human Drug Compounding
* Patient/Non-Patient Specific Compounding
* # Rx Orders for Sterile/Nonsterile Compounded Human Drugs that were: Sent Out, Dispensed, & Distributed Interstate (include all states names as well).
* Whether Compounded Human Drugs are Distributed w/o Patient-Specific Prescriptions

Question 5

Compounding Certifications/Licensure Required?

Answer 5

Outsourcing Facility $400 License Fee

Question 6

Special Requirements for Compounding Patent Drugs? Controlled Drugs? OTC?

Answer 6

Patent Drugs Only Allowed If:
* Meeting Medical Need of Patient
* FDA Drug Shortage in Database

Controlled Drugs:
* Unused portion of controlled substances by compounding operations may be destroyed or disposed of by registrant, paramedic, or a pharmacist in witness of one other licensed care provider/CPhT that is 18 years or older.
* A written record of wastage shall be made and maintained for 2 years.