COMPOUNDED FRESH. EVERY TIME.
MediCaine is produced in a licensed 503A compounding pharmacy that operates under USP 795 nonsterile preparation standards. Every batch is mixed for a specific NPI-verified provider, not bulk-manufactured.
PRESCRIPTION-SPECIFIC. PROVIDER-VERIFIED.
503A is defined by the FDA
Section 503A of the Federal Food, Drug, and Cosmetic Act describes how state-licensed pharmacies and physicians may compound medications for individual patients in response to a specific provider order. Unlike 503B "outsourcing facilities," 503A pharmacies do not produce in bulk for resale — every preparation is matched to a specific licensed provider's order, recorded by patient or practice, and dispensed under state board of pharmacy oversight. This is why MediCaine requires NPI verification before any order ships.
Compounded fresh per order
A bulk-manufactured topical anesthetic sits on a warehouse shelf for months between production and use. A compounded preparation is mixed when the order arrives. For multi-agent formulations like BLT and quad-agent BLT+, freshness matters — Phenylephrine and Tetracaine both have measurable potency decay over long shelf storage. Compounding per order keeps the active concentration close to the labeled value on the day your practice opens the jar.
USP 795 — the standard for nonsterile compounding
The United States Pharmacopeia General Chapter 795 sets the standards for nonsterile pharmaceutical compounding in the US. USP 795 governs facility design, ingredient sourcing, calculation and weighing accuracy, mixing technique, labeling, beyond-use dating, and documentation. MediCaine is compounded under a USP 795 compliant workflow with the documentation trail required for state board inspection.
NPI verification before every order
Every order is checked against the National Provider Identifier registry maintained by the Centers for Medicare and Medicaid Services. Name, NPI number, state license number, and license state must cross-match active CMS records before the order is queued for compounding. Failed verifications generate a follow-up workflow that protects providers and the pharmacy from fraud. Read more on how we verify licenses.
FROM ORDER TO SHIPMENT
- 1
ORDER + NPI VERIFICATION
Configurator selection saved to D1. NPI Registry check against CMS records — name + NPI + state license + license state must match. Verified orders queue for compounding.
- 2
FORMULATION + WEIGHING
Active ingredients (Benzocaine, Lidocaine, Tetracaine, Prilocaine, Phenylephrine) weighed to USP 795 accuracy standards. Each component documented with lot number, manufacturer, and expiry date.
- 3
COMPOUNDING + QUALITY CHECK
Cream or ointment base prepared. Actives incorporated with uniform distribution. Final preparation visually inspected and weight-checked against the target. Lot record entered for audit trail.
- 4
PACKAGING + LABELING
Airless pump, jar, or single-use packet per provider selection. Label includes formulation name, lot number, beyond-use date, and the verified provider's information.
- 5
SHIPMENT
Tracked shipment to the verified practice address on file. Order confirmation and tracking emailed to the ordering provider. Auto-reorder customers receive a reminder before the next batch is queued.
WHAT YOU CAN EXPECT FROM EVERY BATCH
Active concentration accuracy
Multi-agent compounds are mixed to label concentration with the weighing accuracy specified by USP 795. The 20/10/10 in MediCaine Pro means 20% Benzocaine, 10% Lidocaine, 10% Tetracaine — not "approximately."
Documented lot record
Every batch carries a lot number recorded in our compounding log alongside ingredient sources, mixing technique, beyond-use date, and the verified provider's order ID. Records are retained per state board requirements.
Beyond-use dating
Compounded nonsterile preparations carry a beyond-use date determined per USP 795. For aqueous-base topicals like BLT cream, this is typically 35 days from compound date when stored properly. Auto-reorder timing aligns with practical use windows.
Ingredient sourcing
Active ingredients are sourced from US-based pharmaceutical-grade suppliers with documented Certificates of Analysis. Each lot of incoming raw material is logged and matched to outgoing compounded preparations for traceability.
TALK TO A PHARMACIST
Questions about formulation, compatibility, alternative concentrations, or custom orders — our pharmacy team is available by phone during business hours.
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