Industries · Pharmacy / DME
Pharmacy & DME licensing & accreditation
Launch a retail pharmacy, compounding pharmacy, or Durable Medical Equipment (DME) supplier with full state, federal, accreditation, and payer enrollment support.
What we deliver
Everything you need to launch and stay compliant.
- State pharmacy / DME permits (BOP filings, facility inspections)
- DEA Form 224 / 363 for controlled-substance dispensing
- Medicare DMEPOS enrollment (CMS Form 855S) + surety bond
- DMEPOS accreditation through ACHC, BOC, or The Compliance Team
- PCAB or USP 795/797/800 compliance program for compounding
- HIPAA Privacy + Security policies
- Pharmacy management system selection (PioneerRx, Liberty, QS/1)
- PBM credentialing and contracting (ESI, OptumRx, Caremark)
- Inventory, perpetual log, and biennial inventory program
Why owners pick PF Consulting Firm
- Single point of accountability across state, federal, and payer workstreams.
- Fixed-scope engagements with milestone-based delivery.
- Ongoing compliance support after launch on retainer or as-needed.
- Direct work product — not outsourced to overseas teams.
Launch roadmap
Realistic timeline
Phase 1 · Months 1–3
State permit + facility
- State BOP application
- Facility inspection
- DEA filed
- PIC / RPh hired
Phase 2 · Months 3–6
Accreditation
- DMEPOS or PCAB accreditation
- Policy manual + training
- On-site survey
Phase 3 · Months 5–8
Payer enrollment
- Medicare DMEPOS issued
- PBM contracts countersigned
- First fill / first claim
FAQ
Pharmacy & DME Licensing questions
Do I need accreditation to bill Medicare for DME?
Yes. CMS requires DMEPOS accreditation from a CMS-approved organization (ACHC, BOC, The Compliance Team, etc.) plus a $50,000 surety bond per location.
What's the difference between PCAB and USP 795/797?
PCAB is a voluntary accreditation for compounding pharmacies. USP 795 (non-sterile) and USP 797 (sterile) are enforceable compounding standards. PCAB demonstrates compliance with USP standards.
How long to launch a retail pharmacy?
6–9 months is typical. Buildout and state inspection drive the schedule.
Ready to start your pharmacy & dme licensing?
Book a consultation and we'll map every milestone, license, and deadline.
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