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The Homœopathic Pharmacopœia of the United States


May 2014

Instructions for Submitting Public Comments On Documents

The Homeopathic Pharmacopeia Convention of the United States (HPCUS) is pleased to announce the availability for public comment of three draft documents concerning the technical information to accompany monograph submissions, the labeling of homeopathic remedies, and considerations for homeopathic drug stability and shelf life.

The purpose of the Public Comment Periodis to provide an opportunity for the homeopathic community and the general public to offer views, share thoughts and identify questions to be considered regarding how these proposed changes to the HPUS will impact the availability and manufacturing of homeopathic drug products in the United States. Comments are due no later than November 15, 2014.

Providing Written Comments

Comments must be submitted in writing, either by email or U.S. Mail.

1) Comments are especially welcome by email, either in the body of the email itself, or as an MSWord attachment. You must include the name of the document you are commenting on in the subject line of the email. Please note the specific line number and section of the document upon which you are submitting each comment. This will help ensure that the intent of your comment is most clearly conveyed to the appropriate HPCUS Committee. Emailed comments must be sent no later than 11:59 pm PT November 15, 2014 to: efoxman@hpus.com  HPCUS.

2) Comments may also be sent by U.S. Mail, postage prepaid. Please include the name of the document you are commenting at the top of page one of your letter. Mailed comments must be post marked no later than November 15, 2014, and sent to HPCUS, P.O. Box 2221, Southeastern, PA 19399.

A summary of the documents being published today follows.

Draft HPUS Guidelines to Technical Information
Requirements for Monograph Review

Background

The HPCUS Monograph Review Committee (MRC) has created a new guidance document to fill a gap in the guidance documents available from the HPCUS. Until now, monograph sponsors needed to individually communicate with the HPCUS and appropriate committee chairs in order to determine what technical information might be missing from a monographs submission.

Purpose of the Document: Draft HPCUS Guidelines to Technical Information Requirements for Monograph Review

• To help monograph sponsors for homeopathic medicines assemble and format the necessary data to accompany a monograph submission to help ensure the submitted information is in a format that allows the relevant information to be easily accessed and that sufficient detail is provided to ensure the submission will the meet the standards for approval.

• To help guide reviewers who examine monograph submissions to ensure that expected standards of quality and information are being upheld.

Overview of Major Are as of Change

Below is a brief summary of the major focus points of the Draft HPCUS Guidelines to Technical Information Requirements for Monograph Review:

• The draft Guidelines includes both information requirements for approval by the HPCUS and recommendations for "best practices".

• The draft guidelines include details throughout to help monograph sponsors assemble the information for the submission and formatting of necessary data regarding identification, qualification and safety of the proposed starting material.

• The draft Guidelines includes a detailed description of the necessary content for reporting the technical information in a format that will guide the MRC in its deliberations.

Comment Review:

All timely received comments will be reviewed and considered by the MRC. Any changes proposed by the MRC as a result of the comments filed will be reviewed by the Board of the HPCUS.

Timeline for Implementation:

The new guidelines will become effective upon final approval of any changes by the Board of the HPCUS.

Background

The HPCUS Council on Pharmacy (CoP) was tasked with a complete review of the existing Labeling Guidelines document (available at http://www.hpus.com/online_database/show_file_action.php?labeling.htm, by subscription). During this review, the CoP organized the information in logical groupings based on dosage forms. The revised document (HPUS Labeling Guidelines), contains much greater detail about labeling requirements.

Purpose of the Document: HPUS Revised Labeling Guidelines

• To provide detailed guidance to manufacturers and pharmacies regarding compliant labelling for homeopathic drug products.

• To clarify and eliminate ambiguities and misconceptions that may exist regarding labelling requirements.

Overview of Major Areas of Change

Below is a brief summary of the major changes between the existing HPUS Labeling Guidelines and the HPUS Revised Labeling Guidelines:

• The revised document includes labeling information from the FDA Compliance Policy Guide 400.400 (Conditions Under Which Homeopathic Drug Products May Be Marketed).

• The revised document includes appropriate references to relevant sections of the Code of Federal Regulations.

• The revised document in includes details from the recently adopted Guidelines for Manufacturing Homeopathic Medicines.

Comment Review:

All timely received comments will be reviewed and considered by the CoP. Any changes proposed by the CoP as a result of the comments filed will be reviewed by the Board of the HPCUS.

Timeline for Implementation:

After final approval of draft by the Board of the HPCUS, the final HPUS Revised Labeling Guidelines will be posted at the HPCUS website with an implementation date of 31 March 2017.

Homeopathic Drug Stability Guidelines Background

The HPCUS Council on Pharmacy (CoP) was tasked with the creation of a guidance document addressing aspects of homeopathic drug products' stability.

While drafting, the CoP organized the information in logical groupings based on dosage forms and processing and addresses different considerations based on those groupings.

Purpose of the Document: Homeopathic Drug Stability Guidelines

• To provide points for manufacturers and marketers to consider when assessing parameters to consider for realistic and meaningful specifications.

• To clarify the various categories of homeopathic materials for which potentially separate specifications may be needed.

Overview of Major Areas of Change

Below is a brief summary of the major focus points of the Draft Homeopathic Drug Stability Guidelines:

• The draft document provides background information to be taken into consideration.

• The draft document identifies 5 broad categories of homeopathic materials based on dosage form and processes.

• The draft document includes appropriate references to relevant sections of the Code of Federal Regulations.

• The draft document provides suggestions for addressing stability issues and retesting requirements, as well as generally accepted stability time frames.

Comment Review:

All timely received comments will be reviewed and considered by the CoP. Any changes proposed by the CoP as a result of the comments filed will be reviewed by the Board of the HPCUS.

Timeline for Implementation: The new guidelines will become effective upon final approval of any changes by the Board of the HPCUS.