Frequently asked questions

What is a compounding pharmacy?

A 503A compounding pharmacy makes patient-specific medications—custom strength, ingredients, and dosage form—per your prescriber’s directions, in sterile and non-sterile forms under USP ⟨795⟩/⟨797⟩/⟨800⟩ standards.

When a commercial drug doesn’t fit your needs:

  • Different strength/titration
  • Alternative dosage form (liquid, troche, transdermal, sterile injection/ophthalmic)
  • Allergen-/additive-avoidance (no dyes, lactose, gluten, alcohol)
  • Drug shortage/discontinuation or combination of compatible meds

Sterile: injections/IVs, ophthalmics.

Non-sterile: capsules, oral liquids, troches/ODTs, creams/gels/ointments/lotions, transdermals, suppositories, nasal sprays/rinses.

Check your label/packaging for “Compounded Medication,” dosage form, BUD, and lot number—or ask your pharmacist/prescriber. Unusual strengths or nonstandard forms (e.g., troche, sterile vial) are common signs.

Weight management (prescription weight-loss options), hormone therapy, peptides & wellness, allergy immunotherapy (SCIT/SLIT), IV therapy, dermatology/aesthetics, and sexual health—tailored to your provider’s directions.

Which providers can prescribe compounded medications?

Licensed prescribers in the patient’s state: MD/DO, NP/APRN, PA, DDS/DMD, DPM, OD/ophthalmology (where permitted), DVM (animals), and ND/NMD in eligible states. DEA registration is required for controlled meds.

Yes. 503A compounding = custom, patient-specific Rx; not mass-produced; follows USP standards (not FDA-approved products). Manufacturing = FDA-approved, cGMP mass production for resale. (503B outsourcing is a separate FDA-regulated model for office-use batches.)

State Boards of Pharmacy (licensure/inspections, 503A rules), FDA (FD&C Act enforcement; no FDA “approval” of compounded meds), DEA (controlled substances), and USP standards ⟨795⟩/⟨797⟩/⟨800⟩.

  • Patients: Contact us—we can coordinate with a licensed telehealth provider in your state, or ask your current provider to eRx/fax your prescription to AccuMix Pharmacy. We’ll confirm details and arrange shipping/pickup per state rules.
  • Providers/Clinics: Send Rx or request a pharmacist consult for formulation/strength/dosage form.
  • Telehealth: Quick onboarding, formulary setup, and multi-state fulfillment.

Yes—compounding and manufacturing serve different purposes and follow different rules.

503A Compounding (what AccuMix does)

  • Patient-specific: Made only after we receive a valid prescription for one patient.
  • Customized: Strength, ingredients, and dosage form tailored to the prescriber’s directions.
  • Oversight & standards: Performed/supervised by state-licensed pharmacists under state/federal law and USP ⟨795⟩/⟨797⟩/⟨800⟩ standards.
  • FDA status: Compounded medications are not reviewed or approved by the FDA (we follow FDA/USP guidance and source from FDA-registered suppliers).
  • Distribution: Not mass-produced; no broad commercial resale.

Drug Manufacturing (commercial products)

  • Mass production: Large-scale batches of standardized drugs.
  • FDA approval: Products undergo FDA review (e.g., NDA/ANDA) and must meet cGMP manufacturing requirements.
  • Distribution: Sold to wholesalers, pharmacies, and healthcare facilities for resale/dispensing.

A third category you may hear about—503B outsourcing facilities

  • Batch sterile compounding (often for office use), FDA-registered and held to cGMP—but not patient-specific. This is different from AccuMix’s 503A model.

Bottom line: Your prescriber may choose a compounded medication when an FDA-approved product doesn’t meet your needs (e.g., different strength, ingredient exclusions, or alternate dosage form). AccuMix compounds patient-specific preparations under pharmacist supervision and applicable USP standards.