Regulatory Intelligence
for Compounding

Disclosed Labs tracks FDA warning letters issued to compounding pharmacies, peptide vendors, and supplement companies in 2026. The most active enforcement areas include unapproved drug claims, GMP violations at outsourcing facilities, and the ongoing Category 1 bulk drug substance review — which determines which peptides are eligible for compounding. Currently 6 peptides are in the Category 1 review process in our database.

Disclosed Labs monitors seven categories of regulatory activity affecting the peptide and compounding industry: (1) FDA warning letters to pharmacies and vendors, (2) FDA guidance documents on bulk drug substance compounding, (3) DEA scheduling proposals and final rules for peptides and related compounds, (4) state pharmacy board actions including facility requirements and prescribing restrictions, (5) federal legislation affecting compounding access, (6) state legislation on pharmacy practice, and (7) USP standards updates. All alerts link to the original government source.

Under the FDA's 503A compounding framework, the Category 1 bulk drug substances list identifies compounds that may be used by compounding pharmacies without an approved drug application — provided they meet strict quality, safety, and clinical need criteria. Category 1 designation is the critical regulatory gate that determines whether a peptide can be legally compounded and dispensed by licensed pharmacies with a valid prescription. Disclosed Labs currently tracks 6 peptides in the Category 1 review process; as of mid-2026 none are officially confirmed on the finalized 503A list. Status is updated whenever the FDA publishes formal list changes. Changes to this list directly affect prescriber access and vendor compliance obligations.

The regulatory alert feed updates automatically as new FDA, DEA, and state board actions are published to official government sources — typically within hours of the original publication. Critical actions (Category 1 list changes, warning letters naming specific compounds) are tagged HIGH or CRITICAL and trigger immediate email notifications for subscribed prescribers and pharmacies. The feed is browsable for free; email alerts require a subscription.