Some prescriptions contained a statement explaining why a patient needed a compounded drug. FDA still questioned whether the prescriber had made that determination.
In its September 18 warning letter to Empower Pharmacy, FDA cited statements repeated verbatim across many records, missing determinations in others, and the volume of compounded semaglutide and tirzepatide combinations. The agency concluded that the products did not qualify for important exemptions under federal law.
The question was consequential: did the prescription record an individual clinical judgment, or merely supply language that looked like one?
Recording a patient-specific determination is not the same as establishing that one was made.
The Exception Depends on a Difference That Matters to the Patient
Compounding can meet needs that a commercially available medication does not. FDA gives the example of a patient who is allergic to a dye and needs a medication without it. Another patient may be unable to swallow a tablet and need a liquid formulation.
The difference is easy to understand. Removing the dye addresses the first patient’s allergy. Changing the dosage form addresses the second patient’s difficulty swallowing. The modification has a purpose tied to the person receiving the drug.
Section 503A allows qualifying compounded drugs to be supplied without FDA approval and exempts them from certain labeling and current good manufacturing practice requirements. Those exemptions depend on meeting the statute’s conditions.
One condition restricts regular or excessive compounding of products that are essentially copies of commercially available drugs. The statute excludes from that category a drug changed for an identified patient when the prescribing practitioner determines that the change produces a significant difference for that patient.
This is a comparison between the compounded formulation and the commercially available drug. It does not require a finding that compounding is the patient’s only treatment option. It does require a determination about what the change means for that particular patient.
The Record Must Show That the Judgment Was Made
FDA’s 2018 guidance on essentially copies explains how the determination should be documented. A patient name and a formulation alone are insufficient. The record should identify the change and its significance for the patient. A lower price does not establish the required difference.
The guidance also makes an important distinction. FDA generally does not intend to question documented prescriber determinations. It does intend to consider whether the record establishes that a determination was made.
That distinction leaves the medical judgment with the prescribing practitioner while preserving a question for the regulator: does the documentation actually show the exercise of that judgment?
A brief statement can record a substantive decision. A longer statement can fail to do so. The issue is the relationship between the words in the prescription and the patient’s circumstances. The guidance’s own examples of sufficient notations are short: “No Dye X, patient allergy” and “Liquid form, patient can’t swallow tablet.”
What FDA Questioned at Empower
Empower’s products included semaglutide combined with cyanocobalamin and tirzepatide combined with niacinamide. The letter follows a November 2025 inspection. It also comes after FDA’s temporary enforcement discretion for pharmacies compounding these drugs ended, for tirzepatide on March 5, 2025, and for semaglutide on April 24, 2025. FDA questioned whether the asserted differences were genuine and patient-specific.
The letter identifies prescriptions with no determination and others with repeated statements suggesting pre-generated selections. It also warns that third-party platforms offering prescribers preselected explanations can undermine the individualized nature of the judgment. FDA considered these records together with production volume, which it said suggests that the differences from the approved products are pretextual.
The public letter does not reconstruct every prescribing encounter. It does not establish that every repeated statement was unsupported, and it does not categorically prohibit templates or menu options.
The concern it describes is narrower and more substantial: a process can produce the expected statement without establishing the clinical determination on which the exception depends.
Losing the Exception Changes the Legal Consequences
FDA concluded that Empower regularly or in inordinate amounts compounded products that were essentially copies of commercially available drugs. The products therefore lost the Section 503A exemptions.
That brought the ordinary approval, labeling, and manufacturing requirements back into the analysis. FDA identified unapproved-new-drug violations because Empower had no approved applications for these products. It also identified misbranding: the drugs treated conditions requiring medical practitioners, so adequate directions for safe lay use could not be written, and no other applicable labeling exemption covered them.
The letter separately identified adulteration based on insanitary conditions, which apply regardless of Section 503A eligibility. It also cited manufacturing-practice violations for the products that lost the exemption.
The prescriber-determination issue was therefore more than an incomplete-record problem. It affected whether the products could be supplied under the statutory exemptions at all.
