Interactive tool
Compounded Rx Evidence Explorer
Filter official action, study, recall, inspection, license, ingredient, pharmacy, state, date, and status.
Direct answer
This tool runs entirely in your browser against the same canonical datasets that drive the visible pages and the public downloads, so the tool and the pages cannot disagree. It reports what a named public record says on the date it was checked. It issues no badge, score, ranking, or safety verdict of any kind.
Key findings
- Primary focus: Filter official action, study, recall, inspection, license, ingredient, pharmacy, state, date, and status..
- Registration with FDA is not FDA approval, and a state licence is not a quality assessment.
- Unverified fields render fail-closed; no badge, score, or ranking is generated from missing data.
- Current and historical records are separated and labelled distinctly.
- Named entities may respond to any record through the right-to-respond process.
| Filter official action, study, recall, inspection, license | Verification Pending |
|---|---|
| Federal framework | License Verified FDA sources verified 2026-07-23 |
| Entity-specific data | Verification Pending |
Evidence status Verification Pending
Verified 2026-07-23
Reviewer CompoundedRxMonitor Regulatory Desk
Snapshot 2026-07-23
Methodology v1.0
Sources checked 10 FDA sources verified 2026-07-23
Evidence explorer
Every framework fact this platform relies on, with its primary source. 22 verified facts across 10 sources, checked 2026-07-23.
| Point | What the source states | Source |
|---|---|---|
| Dqsa | The Drug Quality and Security Act was signed into law on 27 November 2013 and added section 503B to the Federal Food, Drug, and Cosmetic Act, creating outsourcing facilit | FDA |
| 503B Def | An outsourcing facility is defined as a facility at one geographic location engaged in compounding sterile drugs, that has elected to register as an outsourcing facility, | FDA |
| 503B Cgmp | Drugs compounded by an outsourcing facility can qualify for exemptions from FDA approval requirements and from the requirement to label products with adequate directions | FDA |
| Reg Not Approval | Registration means only that FDA has received the information required to register the facility. It does not mean the facility is making FDA-approved drugs, and it does n | FDA |
| Not Approved | Drugs made by compounders, including those made at outsourcing facilities, are not FDA-approved. They have not undergone the same premarket review as approved drugs and l | FDA |
| Risk Based | Outsourcing facilities are inspected by FDA according to a risk-based schedule. Inspection frequency depends on prior findings, compliance history, recall history, and th | FDA |
| 503A Def | Section 503A describes conditions under which drug products compounded by a licensed pharmacist in a state-licensed pharmacy, or by a licensed physician, are exempt from | FDA |
| 503A Patient | Compounders operating under section 503A can only distribute compounded drugs based on receipt of valid prescriptions for identified individual patients. Outsourcing faci | FDA |
| Reporting | Outsourcing facilities must provide FDA with a list of drugs compounded during the previous six-month period upon initial registration and in June and December each year. | FDA |
| Fees | Outsourcing facilities must pay an annual establishment fee. The registration period runs 1 October to 31 December. An entity that does not pay its annual establishment f | FDA |
| Prefer Approved | FDA recommends that practitioners prescribe an FDA-approved drug rather than a compounded drug when an approved drug is available and appropriate for the patient. | FDA |
| Essentially Copy | Section 503B restricts producing a drug product that is essentially a copy of an approved drug product. | FDA |
| Tirz Order | On 19 December 2024 the FDA issued a Declaratory Order removing tirzepatide injection products from the drug shortage list after determining the shortage was resolved. | FDA |
| Sema Order | On 21 February 2025 the FDA issued a Declaratory Order removing semaglutide injection products from the drug shortage list. | FDA |
| Ofa Litigation | In Outsourcing Facilities Association v. FDA (N.D. Texas) the district court denied the plaintiff's preliminary injunctions on 5 March 2025 and 24 April 2025. | FDA |
| Bulks Proposal | On 30 April 2026 the FDA proposed to exclude semaglutide, tirzepatide and liraglutide from the 503B bulks list, finding no clinical need for outsourcing facilities to com | FDA |
| Bulks Rule | In most cases outsourcing facilities cannot compound drugs using bulk drug substances unless the substance appears on the 503B bulks list, or the compounded drug is on FD | FDA |
| List Contents | FDA's registered outsourcing facility list publishes the facility name, state, whether it compounds from bulk drug substances, whether that compounding is sterile or | FDA |
| List Caveat | On FDA's registered outsourcing facility list, 'Closed' means an inspection was closed without further action and 'Open' means FDA has not determ | FDA |
| Facility Specific | Registration and inspections are facility specific. Facilities under common ownership and control are inspected individually. Before purchasing, FDA advises determining t | FDA |
| State Enforcement | To determine whether a registered outsourcing facility has been the subject of a state enforcement action, FDA directs the public to check with the State Board of Pharmac | FDA |
| Annual Rereg | After initial registration, a facility electing to remain registered must re-register annually and pay the annual establishment fee. Failure to register and pay results i | FDA |
Timeline data as a table
| 2013-11-27 | Drug Quality and Security Act signed; section 503B added, creating outsourcing facilities. |
|---|---|
| 2024-10-02 | FDA removes tirzepatide from the drug shortage list. |
| 2024-12-19 | FDA Declaratory Order removes tirzepatide injection products from the shortage list. |
| 2025-02-21 | FDA Declaratory Order removes semaglutide injection products from the shortage list. |
| 2025-03-05 | District court denies preliminary injunction, Outsourcing Facilities Association v. FDA. |
| 2025-04-24 | District court denies further preliminary injunction in the same litigation. |
| 2026-04-30 | FDA proposes excluding semaglutide, tirzepatide and liraglutide from the 503B bulks list. |
| 2026-06-29 | Comment docket on the 503B bulks list proposal closes. |
What a result from this tool means
What this means
- Every published record resolves to a named source with a check date.
- The status vocabulary is fixed and published, so terms cannot drift.
- Fail-closed fields are visible rather than hidden.
What this does not mean
- That unchecked fields are safe to infer.
- That this platform certifies or endorses anything.
- That a source date is the same as today's status.
What this tool can and cannot settle
A lookup tool answers one question well and creates a temptation to over-read the answer. This one reports what a named public record says on the date it was captured. It does not assess, score, or certify anything, and a result is a starting point for verification rather than its conclusion.
The specific limit worth understanding: a snapshot is not a live query. FDA updates its outsourcing facility register weekly and state boards update continuously, so a result here confirms what the record said on the snapshot date and nothing about today. For anything consequential, go to the source register directly — every result links to it.
Limitations of this record.
- Results reflect a dated snapshot, not a live query against the source register.
- FDA updates its outsourcing facility register weekly; state boards update continuously.
- Self-reported registration information on FDA's list has not been verified by FDA.
- Absence of a result is absence from this snapshot, not evidence that no record exists anywhere.
| Question | Can this tool answer it? | What actually answers it |
|---|---|---|
| Is this facility federally registered? | Yes, as of the snapshot date | FDA outsourcing facility register |
| Is its state licence current today? | No | The issuing state board's live register |
| Has it been inspected? | No | FDA inspection records |
| Were there Form 483 observations? | No | FDA inspection records |
| Is there an active warning letter? | No | FDA warning letter database |
| Is this pharmacy safe to use? | No — and no tool can | No public record answers this question |
Where the detail lives. The eight items to establish before paying any programme are listed on the patient safety page. The six parties in a compounded prescription, and which register holds each, are set out on the provider–pharmacy relationships page.
Related records in this section
Compounding Pharmacy License CheckerSearch legal name; state; license number; status; expiration; discipline; source; last v503B Outsourcing Facility LookupFacility; registration; address; products; inspection; recalls; warning letters; currentProvider–Pharmacy Relationship ExplorerProvider; pharmacy; medication; state; current/historical; evidence; change date; unknowCompounded Drug Recall SearchProduct; ingredient; pharmacy; lot; reason; dates; status; regulator; source.Compounding Warning-Letter SearchEntity; issue; date; response; closeout; related inspection; source.Compounding Pharmacy State-License MapState coverage; resident/nonresident status; verified date; gaps; facility and pharmacy
Section hub: Interactive tools · Methodology · Status definitions · Right to respond
Frequently asked questions
What does this page cover on compounded medication evidence?
Filter official action, study, recall, inspection, license, ingredient, pharmacy, state, date, and status.
What does this monitor track on filter official action, study, recall, inspection, l?
Filter official action, study, recall, inspection, license, ingredient, pharmacy, state, date, and status is tracked as part of compounded medication evidence. The record holding it is named in the source map on this page, and its verification state is shown in the status snapshot rather than asserted in prose.
Where does this tool get its data on compounded medication evidence?
From the same canonical datasets that drive the visible pages and the public downloads, so the tool and the pages cannot disagree.
Sources
- FDA — Information for Outsourcing Facilities
- FDA — Q&A: Outsourcing Facility Registration
- FDA — Registered Outsourcing Facilities
- FDA — Aligning Federal and State Regulation of Compounders
- FDA — Outsourcing Facility Fees
- FDA — Compounded Drug Products That Are Essentially Copies
- FDA — Proposes to Exclude Semaglutide, Tirzepatide and Liraglutide from 503B Bulks List (30 Apr 2026)
- FDA — Registration of Human Drug Compounding Outsourcing Facilities (guidance)
- Nevada Board of Pharmacy — Notice of FDA Declaratory Orders (tirzepatide, semaglutide)
- FDA — Outsourcing Facility Fees guidance
Update history
| Date | Change |
|---|---|
| 2026-07-23 | Record published at current snapshot. |
Dates change only for substantive updates. Entities may submit a correction or response through the right-to-respond process.