Quality standards.
Standards set by pathway, verified by testing and recorded lot by lot, from the raw material to the practice or patient who received it.
Standards by product.
Each product type is made under the standard written for it.
| Attribute | 503APatient-specific | 503BOffice use | SupplementsCustom and private label |
|---|---|---|---|
| Oversight | State boards of pharmacy | FDA registration and inspection | FDA dietary supplement regulations |
| Standard | USP <795> and USP <797> | cGMP, 21 CFR parts 210 and 211 | cGMP, 21 CFR part 111 |
| Release | Pharmacist verification of each preparation | Quality unit batch release on test results | Finished product tested against specification |
| Records | Compounding record per preparation | Batch record and certificate of analysis per lot | Batch record and certificate of analysis per lot |
| Dating | Beyond-use date | Expiration date from stability data | Expiration or best-by date |
Release testing on every 503B lot.
Sterile batches ship only after the quality unit reviews potency, sterility and endotoxin results against specification.
- Potency by HPLC assay against the labeled strength.
- Sterility to USP <71>.
- Bacterial endotoxins to USP <85>.
- Particulate matter to USP <788> for injectables.
- pH to USP <791> for solutions.
Certificate of analysis
Formula MW-04, sterile injectable, 10 mL multi-dose vial
| Test | Method | Specification | Result |
|---|---|---|---|
| Appearance | Visual | Clear solution | Conforms |
| Potency | HPLC assay | 90.0 to 110.0% | 99.4% |
| Sterility | USP <71> | No growth | Pass |
| Bacterial endotoxins | USP <85> | Within limit | Pass |
| pH | USP <791> | 6.5 to 7.5 | 7.1 |
| Particulate matter | USP <788> | Within limit | Pass |
Traceable from raw material to delivery.
Every link is recorded on Pharmagistic, the operations platform behind 10 million+ orders across the network.
- Raw materialSupplier certificate checked at receipt
RM-2609-0912 - BatchFormula, equipment and operator recorded
L2610-0447 - QA releaseResults reviewed by the quality unit
COA issued - AllocationUnits reserved to a practice order
Order 4471 - ShipmentPacking, carrier and tracking recorded
Cold chain - DeliveryPractice or patient on record for the lot
Delivered
Sample identifiers. Fictional data.
Shipping and safety.
Cold chain
Refrigerated preparations ship in insulated packaging with cold packs, scheduled to avoid weekend transit.
Tracking
Carrier tracking and the lot number on every shipment, visible in the provider portal.
Recalls
A lot-level recall reaches every practice and patient shipped from that lot.
Adverse events
503B outsourcing facilities report adverse events to the FDA as required. Report a concern through your provider account.
Storage
Storage and handling instructions on every label and packing slip.
Records
Certificates of analysis and batch records retained for each lot and available to your practice.
Order with a certificate behind every lot.
Open a provider account for 503A prescriptions, 503B office stock and custom supplements.
