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Phytocannabinoid Cannabidiol (CBD)

Introduction

Phytocannabinoid cannabidiol (CBD) is one of the main phytocannabinoids found in the Cannabis sativa L. plant, which has attracted considerable attention from both the scientific and professional communities over the past decade. Unlike tetrahydrocannabinol (THC), CBD has no psychoactive properties and does not cause euphoria, making it one of the safer compounds with significant therapeutic potential.

However, it is essential to distinguish between CBD as a dietary supplement and CBD as an active pharmaceutical ingredient (API). The former is commonly used in commercial products lacking sufficient evidence of quality and stability, whereas the latter is subject to stringent pharmaceutical standards and is used exclusively for the preparation of magistral (compounded) medicines in pharmacies, based on a physician’s prescription.

Regulatory Framework

Status of CBD in Slovenia and the EU

Within the European Union, CBD is not classified as a controlled substance. However, its use in medicinal products requires full compliance with legislation governing medicinal products and active substances.
In Slovenia, CBD intended for pharmaceutical use must meet all API requirements under Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP).

Additionally, the active substance must contain less than 0.2% THC, as higher concentrations alter its legal classification and place it among controlled substances.

Legal Distinction Between Dietary Supplements and Magistral Medicines

CBD products marketed as dietary supplements are not subject to the same level of regulatory oversight as medicinal products. They often lack proof of quality, purity, or stability, which may lead to unpredictable outcomes.
In contrast, magistral medicines are based on:

  • a physician’s prescription,
  • certified pharmaceutical-grade API,
  • oversight by a licensed pharmacist,
  • compliance with pharmacopeial standards and batch traceability.

Such preparations ensure safety, efficacy, and individualized therapy.

CBD as a Magistral Medicine

Prescription and Preparation

A physician may prescribe CBD as a magistral medicine when no suitable commercial alternative exists or when individualized dosing is required. The most common indications include:

  • epilepsy (e.g., Dravet syndrome),
  • spasticity in multiple sclerosis,
  • chronic pain,
  • anxiety disorders.

Pharmacists prepare formulations—most frequently CBD oil solutions in MCT oil—while adhering to pharmacopeial standards and validated stability studies.

Advantages of Magistral Preparation

  • Individualized dosage according to patient needs,
  • Choice of dosage form (drops, capsules, topical preparations),
  • Guaranteed quality and traceability,
  • Possibility of combining active substances (as determined by the physician).

Quality and Safety

The quality of a magistral preparation directly depends on the quality of the active substance. Therefore, pharmacists must use pharmaceutically certified CBD APIs produced in compliance with GMP standards. Such an API ensures:

  • precisely defined purity and CBD content,
  • proven stability within the formulation,
  • absence of contaminants (THC, pesticides, solvents, heavy metals).

Conversely, unregulated products (such as dietary supplements or CBD oils of unknown origin) often fail to meet pharmaceutical standards. These may contain inconsistent amounts of the active substance, impurities, or inaccurate labeling, posing a potential risk to patient safety.

Future Outlook

CBD plays an increasingly significant role in the future of personalized medicine. Research supports its efficacy in:

  • treatment-resistant epilepsies,
  • spasticity associated with neurological disorders,
  • pain syndromes,
  • anxiety and sleep disorders.

A broader adoption of magistral preparations in clinical practice is expected, particularly across EU countries where the legal framework has already been established.

Farmakem positions itself as a reliable partner to pharmacists and physicians by providing certified APIs with full traceability and GMP compliance, enabling the safe, professional, and lawful use of CBD for pharmaceutical purposes.
The company does not engage in the production or sale of dietary supplements but focuses exclusively on regulated pharmaceutical applications of CBD.

Conclusion

Phytocannabinoid cannabidiol (CBD) represents a valuable natural active substance with considerable therapeutic potential. Its use in magistral medicines enables an individualized therapeutic approach but requires strict adherence to pharmaceutical standards.
Only pharmaceutically certified APIs manufactured in accordance with GMP ensure the safety, quality, and traceability that form the foundation of modern pharmaceutical practice.

References

  1. European Medicines Agency (EMA) – Guidelines on Good Manufacturing Practice (GMP) for Active Substances.
  2. European Commission – Regulation (EC) No 1223/2009 and Novel Food Catalogue (CBD entry).
  3. Official Gazette of the Republic of Slovenia – Medicines Act (ZZdr-2), 2014.
  4. World Health Organization (WHO) – Critical Review Report: Cannabidiol (CBD), 2018.
  5. European Pharmacopoeia – General Monographs and GMP Compliance for APIs.
  6. Slovenian Chamber of Pharmacy – Guidelines for the Preparation of Magistral Medicines, 2022.
  7. Iversen, L. (2020). Cannabidiol and its Potential Therapeutic Uses. British Journal of Clinical Pharmacology, 86(1), 30–34.
  8. U.S. Food and Drug Administration (FDA) – FDA Regulation of Cannabis and Cannabis-Derived Products: Questions and Answers.
  9. Farmakem d.o.o. – Internal Quality Documents and Certificates of API CBD Compliance (GMP, CoA).

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