New magistral formula rules

Cannabis companies have waited a long time for regulations on magistral formulas. What are the key points of the new INVIMA requirements?

By: Juliana Salazar

Tailor-made preparations of herbal- based and phytotherapeutical ingredients mixed according to patients’ requirements have become increasingly popular. And the fact that cannabis was next in line to become an active ingredient, after being recognized as a phytotherapeutical plant in 2017, had generated quite a bit of excitement for LPs in the domestic market. In October, after a two-year halt in the proceedings, Colombian producers were finally presented with the main requirements to move ahead in the magistral formula market.

BESPOKE QUALITY: Magistral formulas prepared by expert pharmacists in licensed establishments are the go- to choice for many patients seeking specific treatments. Magistral formulas do not require sanitary registration from INVIMA, the national food and medicine authority. That’s why there are specific guidelines to differentiate it from the mass-sale cannabis medicines that do.

In order to avoid cannabis medicine being disguised as magistral formulas, INVIMA has clearly stated that bespoke products cannot be stocked or advertised. Thus, companies are required to keep track of specific lots and shipments for CBD oil, and any ideas of a warehouse filled with magistral formulas are doomed before they can even get started.

Likewise, advertising the made-to-order formula is more likely to get companies an INVIMA warning or sanction than new customers. Companies are allowed to advertise the magistral formula preparation service, but not the preparation itself.

PRESCRIPTIONS AND RESTRICTIONS: Even though cannabis products are already freely sold in major retailers on the international market, Colombia is starting out by requiring a medical prescription for magistral formulas.

That means that medical professionals are required to formulate the specific amount and concentration of cannabinoids to treat targeted pathologies. If the medical prescription surpasses the legal limit of THC, pharmacies are bound by National Narcotics Fund and local Health Secretariat approval requirements and accredited establishments.

Lastly, Colombian LPs must bear in mind that medical prescription is not the only requirement for pharmaceutical establishments. INVIMA has set a series of specific guidelines, including hiring a pharmacist technical director and complying with government certifications.

GOOD PRACTICES: One specific INVIMA requirement for cannabis-based magistral formulas is that pharmacies must comply with INVIMA’s Manual of Good Practice (Buenas Practicas de Elaboración, BPE). There’s also standard requirements, including fabrication licenses and quota limitations, and in addition, the technical document issued by INVIMA introduces a scientific evidence qualification.

Magistral formulas do not require sanitary registration from INVIMA, the national food and medicine authority.

The very first necessity for cannabis magistral formulas is the existence of published studies in which the cannabis- based preparations and their metabolite concentrations are associated with therapeutic effects and dosage. That said, INVIMA understands that most cannabis companies – and the industry as a whole – is at an early stage, and so has offered an alternative to scientific evidence backed-up by published studies. Magistral formulas must, then, comply with the requirements established for clinical trials, according to the stage and purpose of the research project.