# Compounding pharmacy software that keeps the formula, the lot and the prescription together

> A compounding pharmacy is a pharmacy that makes a preparation to order rather than dispensing a manufactured product, and federal law splits the work in two. Section 503A covers patient specific compounding and caps out of state distribution at 5 percent where the state has signed no memorandum of understanding. Section 503B outsourcing facilities register with FDA each year and report their products in June and December. Neurobird holds the formula, the lot and the prescription on one record.

- URL: https://neurobird.com/compounding/
- Product: Neurobird Compounding Pharmacy Document Automation Platform
- Niche: compounding pharmacy
- Buyer: compounding pharmacies
- Status: in development, open for early access
- Updated: 2026-08-21

## What Neurobird Compounding Pharmacy does

- Version every master formula so the sheet used on a given day can still be produced years later
- Tie each component lot to the preparations made from it, in both directions, for recall
- Calculate and hold beyond use dates against the preparation rather than a shelf label
- Keep registration, reporting and equipment records where an inspector can be walked through them

## How it works

1. **Version the formula** A master formula is an object with versions and effective dates, so the sheet used on a given day is recoverable rather than reconstructed.
2. **Bind the lots** Each component lot is attached to the preparation it went into, so one query answers both recall directions instead of a week in a log book.
3. **Date and dispense** Beyond use dates attach to the preparation and travel with it, and the prescription or the facility order that received it stays linked to the lot.

## From the source material

> Outsourcing facilities are a category of compounders established in 2013 by the Drug Quality and Security Act.

Source: US FDA, human drug compounding, https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers

## Industry context

- **750** More than 750 cases of infection and more than 60 deaths across 20 states in 2012, traced to contaminated drugs compounded by one Massachusetts pharmacy. (source: US FDA, human drug compounding laws, https://www.fda.gov/drugs/human-drug-compounding/compounding-laws-and-policies)
- **2013** The Drug Quality and Security Act was enacted on 27 November 2013 in response to that outbreak, creating the outsourcing facility category alongside section 503A. (source: US FDA, human drug compounding laws, https://www.fda.gov/drugs/human-drug-compounding/compounding-laws-and-policies)
- **5 percent** The share of compounded drug products a 503A pharmacy may distribute out of the state where they were compounded when that state has not signed the standard memorandum of understanding. (source: 21 USC 353a, https://www.law.cornell.edu/uscode/text/21/353a)
- **98** Facilities on FDA's registered outsourcing facility list at the 18 August 2026 update. Registration runs between 1 October and 31 December each year or the facility comes off the list. (source: US FDA, registered outsourcing facilities, https://www.fda.gov/drugs/human-drug-compounding/registered-outsourcing-facilities)
- **12 months** The maximum interval between calibrations of an incubator without manufacturer specifications in California, with cleaning at least every 30 days. (source: California State Board of Pharmacy, compounding regulation FAQs, https://www.pharmacy.ca.gov/licensees/compounding_reg_faqs.pdf)

## Pricing

- Single pharmacy: $249 per month
- Sterile: $649 per month
- Outsourcing facility: $1,500 per month

## Questions

### What is the difference between 503A and 503B?

Section 503A covers traditional pharmacy compounding against patient specific prescriptions. Section 503B created outsourcing facilities, which register with FDA, work to current good manufacturing practice and may supply office stock without a patient name. A 503A pharmacy without a state memorandum of understanding may send only 5 percent of its compounded products out of state.

### What is a master formula record?

It is the controlled recipe for a preparation: components, quantities, equipment, procedure, beyond use dating and the checks required. Versioning it matters because a batch made two years ago has to be explainable against the sheet in force on that day, not the current one.

### Does this replace our pharmacy dispensing system?

No. It sits beside it. The dispensing system handles prescriptions and billing. This holds the batch: formula version, component lots, beyond use date and the release, which is the part a recall or an inspection actually asks about.

### Can it answer a recall in both directions?

That is the point of holding lots on the preparation. From a bulk substance lot you get every preparation made with it, and from a preparation you get every lot that went into it.

## Sources

- [US FDA, human drug compounding laws](https://www.fda.gov/drugs/human-drug-compounding/compounding-laws-and-policies)
- [21 USC 353a, pharmacy compounding](https://www.law.cornell.edu/uscode/text/21/353a)
- [21 USC 353b, outsourcing facilities](https://www.law.cornell.edu/uscode/text/21/353b)
- [US FDA, registered outsourcing facilities](https://www.fda.gov/drugs/human-drug-compounding/registered-outsourcing-facilities)
- [California State Board of Pharmacy, compounding regulation FAQs](https://www.pharmacy.ca.gov/licensees/compounding_reg_faqs.pdf)

## Contact

- office@neurobird.com
- https://neurobird.com/