Good Herbal Compounding and Dispensing Practices
White paper: Good Herbal Compounding and Dispensing Practices
Best practices for compounding and dispensing herbal formulations
The American Herbal Products Association (AHPA) has issued a white paper to guide qualified practitioners who compound herbal formulations for clients based on one-on-one consultations.
The Good Herbal Compounding and Dispensing Practices white paper is a free resource to help acupuncturists, herbalists, naturopaths and other adequately trained professionals use best practices when compounding and dispensing herbs and herbal formulations.
The white paper was drafted by a working group of AHPA's Chinese Herbal Products Committee and is based on standard good manufacturing practice concepts such as sanitation of facilities and equipment, quality control practices, documentation of procedures, and record-keeping.
"One of AHPA's core functions is to encourage industry self-regulation and adoption of best practices that protect consumers, patients and access to herbs and herbal formulas," said AHPA President Michael McGuffin. "Broad industry adoption of principles in this white paper will also help preserve the current federal regulatory approach which effectively meets the needs of consumers and practitioners."
Under current regulations, adequately trained practitioners can expect the U.S. Food and Drug Administration (FDA) to exercise enforcement discretion for federal current good manufacturing practice (cGMP) requirements for dietary supplements.
The types of herbal formulas covered in this document include herbal formulas in different forms, including water decoctions, other liquid extracts, granules, powders or pills, as well as poultices, pastes, liniments, etc.
To date the white paper has been distributed to the American Herbalist Guild, American Association of Naturopathic Physicians, American Society of Acupuncturists, American Association of Acupuncture and Oriental Medicine, National Certification Commission for Acupuncture and Oriental Medicine, Chinese Herb Trade Association of America, and American Association of Chinese Medicine and Acupuncture.
AHPA invites feedback on the document to help ensure it is relevant to practitioners trained in a variety of disciplines.
Personnel Training Log for Herbal Compounding and Dispensing
Track and record the training of personnel who compound and dispense herbs
The Personnel Training Log is available to assist with implementation of Section 3.1 Training. This template can be used by practitioners to create a form to track and record the training of their personnel.
Document the detailed information for each herbal formula compounded
The Herbal Formula Specification helps implement of Section 6.1(b) Procedures. By utilizing this template, practitioners can document the detailed information for each herbal formula compounded by the practice for reference as the “master” record of the composition of the formula.
Document the system used to ensure ingredient quality
The Ingredient Qualification Form helps with the implementation of Section 6.2 Ingredients. This tool assists practitioners in implementing the best practices in to qualify the ingredients used in their practice.
Herbal Compounding Record
Record what was compounded for a client’s herbal formula
The Herbal Compounding Record is available to assist with the implementation of Section 9.1 of the same name. This form is intended for use during the compounding process, so that the practitioner has a record of what was compounded.
Herbal Dispensing Record
Recording information pertinent to the dispensing process, including recommendations for use
The Herbal Dispensing record is available to assist with the implementation of Section 9.2 of the same name. This form is intended for use following the compounding process to record information pertinent to the dispensing process.
Client Complaint Report for Herbal Compounding and Dispensing
Capture pertinent information needed to determine if a complaint warrants specific follow-up action
The Client Complaint Report is available to assist with the implementation of Section 10.1 Complaints. This form is intended to assist the healthcare practice in capturing the pertinent information needed to determine whether a complaint received by a client warrants specific follow-up action on the part of the healthcare practice.