Are You Certain Your Homeopathic Attenuation Labeling is Correct?

November 8, 2021

By Eric Foxman, Pharm., AAHP Secretary

 

FDA noted some concerns that homeopathic drug products may not always be labeled to clearly indicate whether homeopathic attenuations have been made using the Hahnemannian or the Korsakovian method. These remarks were made Richard Lostritto, PhD, Associate Director for Science, Office of Policy for Pharmaceutical Quality at FDA’s CDER in his keynote speech at the June 2021 AAHP Summit: Developing HPUS Guidelines for FDA Compliance, Part 2.

Dr. Lostritto suggested there are different types of inherent inaccuracies that can manifest in these two methods, and hinted that better labeling might be desirable.

Since then, the HPCUS Council on Pharmacy reviewed this stated concern in light of the Homeopathic Pharmacopeia of the United States Guidelines for Manufacturing Homeopathic Medicines, in particular Chapter 25 [1]. It may be that some personnel at FDA may not be familiar with this chapter and its requirements. Nevertheless, there is also unease that these requirements are not consistently implemented throughout the entire homeopathic industry, thus leading unnecessarily to regulatory attention and questions.

It might be helpful to have a quick reminder of what the HPUS requires when describing the attenuation of a product’s ingredient(s). Subchapter 25.2 says liquid attenuations must be designated with both the scale of attenuation (decimal or centesimal) and the attenuation method employed (Hahnemannian or Korsakovian). While that might seem like a lot of information to put on a label, the same subchapter shows how it can be done with just one or two characters:

  • Use X or D to indicate the Decimal scale made according to the Hahnemannian method.
  • Use CH or C to indicate the Centesimal scale made according to the Hahnemannian method.
  • Use CK or K to indicate the Centesimal scale made according to the Korsakovian method.

The next three subchapters reiterate this information in different words. Subchapter 25.3 notes the preferred designation for decimal attenuations is X. This indicates the scale used. Since all decimal attenuations are prepared using the Hahnemannian method, this designation also tells the method used — by implication.

Subchapter 25.4 gives two alternatives for Hahnemannian centesimal attenuations: the preferred designation is CH. These two characters indicate both the scale and the method of attenuation. Because C is a stand-in for CH, it can be used only for attenuations prepared according to the Hahnemannian method.

Likewise, subchapter 25.5 provides for two possible designations for Korsakovian centesimal attenuations: the preferred one is CK, because it clearly informs the user as to both the scale used and the method of attenuation. At the same time, K, as a proxy for CK, can be a designation only for attenuations prepared according to the Korsakovian method.

And your homeopathic products? How are your attenuations designated? Are they labeled in compliance with this chapter of the HPUS Guidelines for Manufacturing Homeopathic Medicines? If not, how will your company respond when an FDA inspector asks: why not?

[1] https://www.hpus.com/online_database/show_file_action.php?GMHM/gmhm-page25.php, accessible by subscription.

Posted in Compliance