Pharmacy Licensing & DEA Compliance

Assessment for state pharmacy board licensure and DEA controlled substance registration for pharmacies and research facilities

PharmacyHealthcareResearchBiotech minutes18 questions

1. Pharmacy Licensure

Is the pharmacy licensed by state board with current, unexpired registration?*

State pharmacy license: Renewal annually or biennially, display certificate, notify board of changes (PIC, location)

Is pharmacist-in-charge (PIC) designated and reported to state board?*

PIC: Active pharmacist license, responsible for compliance, sign all reports, must be onsite per state rules

Are all pharmacists and pharmacy technicians currently licensed/registered?*

Verify active status: State board lookup, renewal dates tracked, continuing education completed

2. DEA Registration

Is DEA registration current for appropriate schedules (CII, CIII, CIV, CV)?*

DEA registration: Form 224 (new), 225 (renewal every 3 years), separate for each location, display certificate

Are changes of location, name, or responsible person reported to DEA within 30 days?*

DEA Form 225a: Modification of registration; new DEA number issued for location changes

Are DEA 222 order forms (for CII) completed and maintained for 2 years?*

DEA 222: Triplicate order form for Schedule II; electronic CSOS alternative available with digital certificate

3. Controlled Substance Security

Are Schedule II controlled substances stored in locked, substantially constructed cabinet/safe?*

DEA security: CII separate locked storage; CIII-CV dispersed or locked; alarm system for pharmacy

Are thefts/losses of controlled substances reported to DEA (Form 106) within 1 business day?*

DEA Form 106: Report theft/significant loss to DEA Field Office and state board immediately

Is employee access to controlled substances restricted with accountability measures?*

Access control: Limited staff with keys/combinations, video surveillance, random audits

4. Recordkeeping & Inventory

Are controlled substance records maintained separately for 2 years?*

Recordkeeping: DEA 222 forms, invoices, prescriptions, inventory records; CII separate from CIII-CV

Is biennial controlled substance inventory conducted on May 1 or at DEA registration?*

Biennial inventory: CII exact count, CIII-CV estimated if <1000 units; initial inventory on first day of registration

Are perpetual inventory records maintained for Schedule II substances?*

Perpetual inventory: Track every CII dose received and dispensed; reconcile monthly

5. Compounding Standards

Are compounding areas compliant with USP <795> (non-sterile) or <797> (sterile) standards?*

USP <797>: ISO Class 7 cleanroom, ISO Class 5 hood, environmental monitoring, garbing; <795>: Beyond-use dating

Are master formulation records and compounding logs maintained for each preparation?*

Compounding documentation: Formula, beyond-use date, lot numbers, pharmacist verification, quality testing

Is sterile compounding personnel training documented with media fill testing?*

USP <797>: Annual media fill, gloved fingertip sampling, initial/annual competency assessment

6. Prescription Dispensing

Is pharmacist verification performed for all dispensed prescriptions?*

Final verification: Pharmacist checks drug, strength, quantity, directions, patient profile, counseling

Are patient profiles maintained with allergy, drug interaction, and disease state screening?*

Patient profile: Demographics, allergies, medical conditions, prescription history, OTC consult

Are prescription hard copies or electronic records maintained for required timeframe (typically 2 years)?*

Prescription retention: CII separate, CIII-CV with other records, electronic backups, readily retrievable

Please answer all required questions to see your results