February 20, 2026
In late July 2025, Colombian media reported that the Ministry of Justice circulated a draft decree that would allow adults to legally purchase psychoactive products through pharmacies and drugstores—but only with a medical prescription. The concept is often described as a “medical‑gate” adult‑use model: adult access expands, yet the distribution channel and controls look more like a tightly supervised medical program than a retail dispensary rollout.
Since then, Colombia has continued moving in this direction. In October 2025, the government issued Decree 1138 of 2025, which updated the health-sector framework (modifying parts of Decree 780 of 2016) and recognized flower as a finished product for medical use that can be dispensed with prescription through authorized pharmaceutical establishments—alongside other regulated dosage forms and magistral preparations.
For compliance leaders, export operators, pharmacy chains, and investors, the key question is no longer whether Colombia has a regulated ecosystem—it does. The question is how a prescription-only expansion (drafted in 2025 and partly reflected in subsequent reforms) could reshape licensing strategy, track‑and‑trace expectations, GMP/GACP alignment, labeling/packaging, and market access pathways.
This article is informational only, not legal advice.
Colombia’s regulated model has been building since Law 1787 of 2016, which created a framework for safe and informed access for medical and scientific uses.
The operational backbone is built across multiple authorities and instruments:
Two prior policy shifts matter for understanding the draft decree’s logic:
1) Export liberalization: Colombia’s reforms since 2021 (notably Decree 811 of 2021 and its implementing rules) enabled broader commercialization and helped unlock dried flower export pathways.
2) Industrial/non-psychoactive product rules: Resolution 227 of 2022 implemented Decree 811 and set out procedures for licensing/quotas/authorizations, including for industrial uses tied to non‑psychoactive components.
Official references:
Reporting from late July 2025 described a draft that would allow sales of psychoactive products to adults through pharmacies upon presentation of a medical prescription.
Key elements highlighted in press coverage included:
Sources (media summaries of the draft):
Even though some headlines framed the draft as legalization for adults, the structure described is closer to expanded medical access:
For international operators, this distinction matters because it changes assumptions about:
On October 27, 2025, Colombia issued Decree 1138 of 2025 updating the health-sector rules for safe and informed access. Among the most consequential shifts, the decree recognized flower as a finished product for medical and veterinary purposes and enabled dispensing via pharmacies/drugstores under prescription within the authorized framework.
Official references:
Public reporting around Decree 1138 emphasized a two-year priority/exclusivity window for micro, small, and medium domestic cultivators to supply the national medical market for this finished-product category.
From a compliance and commercial planning perspective, any transitional window like this creates immediate diligence tasks:
A prescription-only “adult-use” layer doesn’t eliminate Colombia’s existing licensing framework—it overlays it. For businesses, the strategic shift is that domestic demand may start to matter nearly as much as export demand, but under medical-style constraints.
If your operation historically focused on exports (particularly flower), the domestic Rx channel introduces new expectations:
For retail pharmacy operators, the compliance story is less about “dispensary rollout” and more about controlled inventory:
If the final framework explicitly allows inhaled routes (smoked/vaporized) under prescription—as described in some draft reporting—pharmacies should anticipate heightened scrutiny around patient counseling, warnings, and safe use communications.
Colombia’s regulatory ecosystem includes the Mecanismo de Información para el Control de Cannabis (MICC), a digital platform used for regulated reporting and activity registration.
Official MICC references:
Export chains often terminate at a logistics handoff plus foreign import documentation. A pharmacy endpoint introduces:
The July 2025 reporting suggested a strong preference for dosified presentations and measured quantities (grams/milliliters) for certain formats.
For 2026 planning, businesses should monitor final/implementing rules for:
Even when rules do not specify a universal THC cap, regulators often enforce product differentiation through:
A pharmacy-dispensed model tends to pull the whole supply chain toward pharmaceutical-grade discipline.
While “GACP” may show up more in international buyer requirements than in a single Colombian statute, the operational expectation is consistent:
ICA resources relevant to seed/plant material oversight and agricultural controls:
For magistral preparations and other finished products, INVIMA certification for the appropriate scope of good practices becomes central.
INVIMA’s cannabis/regulated products landing page and framework reminders:
A prescription-only model heavily restricts the “brand marketing” playbook.
In Colombia, the publicity and promotion of Rx medicines is tightly controlled and generally limited to restricted professional audiences under defined conditions.
A key compliance reference point is the updated regulatory approach reflected in Resolution 1896 of 2023 (widely discussed by practitioners and referenced by INVIMA’s advertising control guidance).
Practical compliance implications:
INVIMA advertising control guidance (includes restricted-access discussion):
If products are dispensed through pharmacies under prescription, packaging tends to be evaluated as part of a health-protection framework:
Even for plant material sold by gram, regulators can demand consistent labeling that makes it feasible to:
Your research note correctly flags one of the biggest open questions: whether Colombia will recognize foreign GMP certifications or certificates of analysis for imports, and under what conditions.
At minimum, INVIMA generally requires that regulated products comply with its registration and import rules, and that establishments and products meet applicable sanitary controls.
INVIMA reminds that regulated products generally require Registro Sanitario for production, import, export, processing, packaging, and commercialization:
For businesses planning cross-border trade (importing finished products into Colombia or exporting from Colombia into tightly regulated destinations), the safest compliance posture is:
Prescription-only access increases the political and regulatory need to demonstrate control. Expect enforcement attention on:
Consumer protection enforcement can also arise via general advertising/consumer rules, including scrutiny for misleading claims.
SIC reference point for consumer/advertising principles (example of 2025 SIC guidance on misleading advertising concepts):
Because the shift is happening through both draft instruments and final decrees, timing matters.
Key moments to track:
Official Decree 1138 reference for monitoring implementation deadlines:
Legislative tracking (Cámara de Representantes adult-use page):
Colombia’s direction of travel is clear: the country is building a more scalable, controlled, and internationally legible system—one that can support both exports and a more accessible domestic Rx market. The compliance burden doesn’t shrink; it becomes more pharmacy-centered and data-driven.
To stay ahead, businesses should monitor:
For compliance checklists, licensing workflow support, and ongoing regulatory monitoring, use https://cannabisregulations.ai/ to keep your team aligned as Colombia’s prescription-focused rollout evolves.
