FDA issues Import Alert 66-80 on GLP-1 ingredients

The US Food and Drug Administration has put the raw ingredients used to make GLP-1 drugs under one of its toughest import tools. Under Import Alert 66-80, FDA field divisions "may detain without physical examination (DWPE) shipments of GLP-1 APIs offered for entry, except for the products and firms identified on the Green List of this Alert" ^[1]. In plain terms, a shipment of bulk semaglutide or tirzepatide powder can be held at the border on the appearance of adulteration alone, without anyone opening or testing it.

API stands for active pharmaceutical ingredient — the bulk drug substance that compounding pharmacies and other manufacturers turn into finished vials or syringes. FDA states that GLP-1 APIs are drugs under section 201(g)(1)(D) of the Federal Food, Drug, and Cosmetic Act because they are intended for use as a component of a drug product, and so they must meet current good manufacturing practice (CGMP) requirements ^[1].

What FDA found

The agency says it conducted onsite inspections and remote regulatory assessments of 48 GLP-1 API sites, using requests for records under section 704(a)(4) of the FD&C Act, to evaluate registered GLP-1 API manufacturers in the US supply chain. Of those 48 sites, FDA found that 21% were noncompliant under section 501 — either because their responses to records requests showed CGMP violations, or because they did not answer FDA's request in a timely manner ^[1].

FDA also describes a repeating pattern: sites that "register as GLP-1 API manufacturers, offer GLP-1 APIs for import, refuse to answer FDA's requests for records, and then deregister, all within a short period of time" ^[1].

The alert ties this back to the shortage era. FDA writes that shortages of approved GLP-1 products led to increased compounding using APIs from foreign sources in China, India and Europe ^[1]. It adds a specific risk: compounders whose drugs meet the conditions of section 503A are exempt from CGMP requirements, including the requirement to ensure the API meets specifications for impurities or potency, so "there is a heightened risk that any quality concerns associated with the bulk drug substance would not be adequately controlled for or monitored during the compounding of finished dosage forms" ^[1].

Who is exempt

The Green List names registered foreign manufacturers whose facilities and products appear, based on FDA's review of recent evidence, to comply with CGMP ^[1]. The version of the alert posted by FDA lists firms in Belgium, Canada and China, covering product codes for semaglutide, tirzepatide, liraglutide, exenatide, orforglipron, and peptide and anti-diabetic categories that include retatrutide ^[1]. The firm names are not displayed in the text available here.

The posted page carries a published date of 08/21/2026 and describes a major revision responding to a March 19, 2026 memo from FDA's Office of Manufacturing Quality ^[1]. That revision adds orforglipron API to three Green List manufacturers, adds orforglipron SDD — a drug product intermediate — to one manufacturer, and creates new product codes, including 61P[][]77 for orforglipron and several codes for "Hormone N.E.C." ^[1]. Orforglipron is the molecule marketed as Foundayo.

Why it matters for patients

This alert targets ingredients, not finished prescriptions from a pharmacy counter. Ozempic, Wegovy, Rybelsus, Mounjaro and Zepbound are FDA-approved products made by their manufacturers and are not what the Green List governs.

The practical pressure falls on compounded and gray-market GLP-1 products, which depend on imported bulk powder. If a supplier is not on the Green List, its shipments can be detained, which can mean delays or gaps for businesses that rely on that source. FDA's own numbers — roughly one in five of 48 evaluated sites found noncompliant ^[1] — give a sense of why the agency considers the appearance of adulteration widespread enough to justify a blanket detention policy.

The alert also spells out how tough the exit ramp is. To get on the Green List, a manufacturer must supply items such as certificates of analysis for its last ten API lots, release specifications with scientific justification for impurities and potency, stability data, process validation reports, master batch records, a list of all out-of-specification results, and five years of complaint, adverse event, recall and return summaries ^[1].

What happens next

FDA notes that a firm can also be removed from the Green List if the agency gets information that its products are no longer made in compliance ^[1]. Petitions go to the Division of Import Operations and are referred to CDER for evaluation ^[1]. How many firms will be added or dropped, and whether detentions affect specific US compounders, is not stated in the alert.