FDA Issues Draft Guidance Document on Good Reprint Practices March 3, 2008
On Feb. 15, 2008, the FDA issued a draft guidance document on good reprint practices for manufacturers of drugs and medical devices. Public comment can be submitted for 60 days from 02/15/08. A one-page pdf file summarizes the draft guidance and provides links to the doucument and to comment submission.
The Dietary Supplement and Nonprescription Drug Consumer Protection Act February 19, 2008
The Dietary Supplement and Nonprescription Drug Act, administered by FDA, became effective on 12/22/07. A one-page pdf file summarizes its provisions, with emphasis on serious adverse event reports (SAER's) and labeling requirements.
CMS ISSUES "STARK III" FINAL RULE September 10, 2007
On September 5, 2007, Centers for Medicare & Medicaid Services (CMS) published in the Federal Register the third version of the Stark Rule, which governs self-dealing and kickbacks in the treatment of Medicare and Medicaid patients. The final rule takes effect December 4, 2007. This one page pdf file guides you to the text of the final rule, and to CMS resources on self-dealing.
The FDA published in the Federal Register on June 25, 2007 its final rule for current good manufacturing practice (CGMP) for dietary supplements. Herbalist practitioners are defined therein as manufacturers of dietary supplements subject to the rule. The FDA will consider the use of enforcement discretion with respect to such practitioners. Given the rule's requirements and the FDA's enforcement stance, how should herbal practitioners proceed in response? This 2-page pdf file presents the pros and cons of three options for herbalists.
FDA CGMP for Dietary Supplements - Initial Post June 22, 2007
On June 25, 2007, the FDA will publish the final rule for current good manufacturing practice for dietary supplements. This one-page pdf file provides a brief overview of some key provisions. It will be followed later by a more comprehensive report.
Several federal agenciues have issued guidance for healthcare workers and employers on preparing for and responding to pandemic influenza. This one-page pdf file will direct you to key resources that can be used in developing your clinic's emergency and infection control management plans.
OSHA COMPLIANCE: HOW CLEAN NEEDLE TECHNIQUE FALLS SHORT May 8, 2007
This article points out a sampling of serious shortcomings in the current Clean Needle Technique (CNT) manual (5th Ed.). Relying solely on CNT for guidance, acupuncturists will not obtain essential information needed for OSHA compliance and for health protection.
Authored by D. Kailin. Published in the California Journal of Oriental Medicine (CJOM), v.18.1, copyright California State Oriental Medical Association (CSOMA), 2007, posted here in pdf format by kind permission of CSOMA.
Errata: The second sentence of the article should begin with: "NAF has produced the fourth and fifth editions...". (I had stated in error that NAF produced five editions.)
NATIONAL PROVIDER IDENTIFIER: AN URGENT REMINDER April 26, 2007
All HIPAA-covered entities must have a National Provider Identifier (NPI) for use on standard transactions by May 23, 2007. This applies to individual healthcare providers and to health services organizations. The NPI is used on all standard transactions, such as health insurance claims. Information on the application process is provided in pdf format, copyright 2007, D. Kailin.
COMMENTARY ON FDA DRAFT GUIDANCE FOR CAM PRODUCTS April 24, 2007
There's been a (mostly mis-guided) flap in CAM circles lately over this recent FDA draft guidance document. Read about what the draft guidance document contains, and what it ought to convey to CAM professionals. Posted in pdf format, copyright 2007 D. Kailin.
FDA PROPOSED RULE FOR CURRENT GOOD MANUFACTURING PRACTICE (cGMP) FOR DIETARY SUPPLEMENTS: AN UPDATE March 14, 2007
In 2003, the FDA proposed changes to good manufacturing practices for dietary supplements. That proposal is still working its way through the rule-making process. It is the most significant FDA action of the last two decades with respect to impacts on CAM. In the Federal Register of March 13, 2003 (68FR12157), pages 12175-6,
you will find this: "Herbalist practitioners who introduce or deliver
for introduction into interstate commerce, a dietary ingredient or
dietary supplement, are manufacturers who must meet CGMPs." Due to high compliance costs (estimated at over $60,000 in the first year for small entitites), the rule will effectively end the practice of in-office herbal compounding. Read about the status of this proposed rule, and how national CAM organizations have responded to date. Posted in pdf format, copyright D. Kailin, 2007.
THE DARK SIDE OF ORGANIZATIONS AND A METHOD TO REVEAL IT David A. Bella, Johathan B. King, & David Kailin Emergence 5(3), 66-82, copyright 2003, posted by permission. http://emergence.org
Some of my articles address specific problems that stem from organizations. This one addresses common systemic behaviors that contribute to many of those specific problems. A 17 page article, 1.23 MB pdf file.
