USP Quality Matters Blog Entries
With growing concerns about the availability of medical appointments and medicines in these days of COVID-19, people are relying more and more on dietary supplements to support their health. According to IRI – a market research firm that tracks U.S. multioutlet sales, including in mass market, grocery, drug, and convenience stores (but not specialty vitamin stores such as The Vitamin Shoppe) – there was an increase of 35% in sales for overall dietary supplements in the first weeks of COVID-19 (March 2020).
Dietary supplements are vitamins, minerals, amino acids, herbs or other botanicals taken to increase the total dietary intake of specific dietary ingredients. Dietary supplements are regulated by FDA as foods but are often taken by consumers to help support overall health, or sometimes to address specific health conditions. Several food ingredients have long been known for their health benefits when used as a normal part of the diet and have been formulated into dietary supplements for that purpose.
“Green tea, for example has been touted for its purported health benefits such as promoting weight loss, improving brain function and even claims that it cures some types of cancer. Similar to many botanical dietary supplements, available evidence is insufficient to support most of these health benefits, and some botanicals can actually be harmful,” says Hellen Oketch-Rabah, Ph.D., senior manager for dietary supplements and herbal medicines at USP.
Although traditional green tea as a beverage has a long history of consumption, the use of green tea extract (GTE) is relatively recent and has gained wide popularity as an ingredient in dietary supplements (DS), especially in products promoting weight loss.
The USP Dietary Supplements Expert Committee started investigating reports of liver injury associated with the consumption of green tea extract (GTE) in 2008 and published a review article in which they proposed the inclusion of a label caution statement based on evidence from 34 adverse event reports that were reviewed. However, the proposal was abandoned as the evidence was considered inadequate. As is USP practice of continuously reviewing its standards and guidelines, the EC continued to monitor the literature for further cases of liver injury related to GTE and in 2016, USP decided to re-introduce a cautionary labelling statement based on additional data that showed that GTE continued to be associated with liver injury. Even then, the Expert Committee judged that the information reviewed was still insufficient to determine whether the reports of liver damage were due to GTE itself or external factors, such as contamination occurring during the manufacturing process.
At that point, USP convened a Green Tea Extract Hepatotoxicity Expert Panel, which was tasked with performing a comprehensive review of the literature on GTE-related hepatotoxicity to better understand the relationship between the reported toxicity to the liver and other factors such as chemistry, manufacturing, and controls (CMC), intake of known compounds of GTE, and how the body processed these compounds (pharmacokinetics and pharmacodynamics).
The results of the work from the Expert Panel were published in February 2020 in the journal Toxicology Reports. Authors of the manuscript are experts from industry, academia and regulatory agencies.
The manuscript concluded that GTE may contain solvent residues, pesticide residues, and other impurities that can cause liver damage in susceptible people. But, of greatest significance, was research suggesting that a specific compound in green tea that is most abundant (Epigallocatechin gallate or EGCG), can saturate the liver, increasing the potential to liver disease.
“These findings are important because the process of manufacturing green tea extract may vary greatly from one manufacturer to another,” says Kristi Muldoon Jacobs, Ph.D., USP’s regulatory science affairs director. “While one product containing green tea extract may have a low amount of EGCG, another may have an enormous amount and cause damage if taken frequently. We can’t be certain which manufacturing processes are used to prepare GTE in the market, so that’s why it is important to have a standard available to manufacturers.”
USP currently has public quality standards available for Powdered Decaffeinated Green Tea Extract, which besides describing GTE and its components, and how to test for unwanted contaminants and impurities, require manufacturers of dietary supplements claiming compliance with this standards to include the following cautionary statement on their product label: “Do not take on an empty stomach. Take with food. Do not use if you have a liver problem and discontinue use and consult a healthcare practitioner if you develop symptoms of liver trouble, such as abdominal pain, dark urine, or jaundice (yellowing of the skin or eyes).”
“The label is important for consumers for a couple of reasons,” says Muldoon-Jacobs. “First, it informs consumers of the potential adverse effects associated with this particular ingredient, how to reduce the risk of adverse effects occurring, and how to recognize symptoms that require medical help. Also, it lets consumers and distributors know that the dietary supplement was manufactured in accordance with a USP quality standard, offering greater assurances of quality manufacturing.”
For those wondering whether brewed green tea has the same side effects as consuming GTE, both Oketch-Rabah and Muldoon-Jacobs respond that you can keep drinking your green tea. The amount of EGCG and other components in brewed green tea is much less than the concentrated GTE and has not been associated with any adverse effects.
“The take-home message here is to talk to your health provider before consuming any dietary supplement. He/she knows your pre-existing conditions, how supplements may interfere with medicines you are currently taking, and how taking a dietary supplement might affect your health” explains Muldoon-Jacobs.
In conversations about the role of quality standards in public health, you might come across the words “compendia” and “compendial.” At USP, terms like “compendial approaches,” “compendial standards,” and “compendial tools” are part of our everyday vocabulary. But their meaning can be a bit of a mystery to people who work outside of the pharmaceutical industry and regulatory bodies.What is a Compendium?
A compendium is a compilation of knowledge about a particular subject (“compendia” is plural and “compendial” is an adjective). This collection of knowledge plays a critical role in protecting public health, especially for medicines and other aspects of healthcare.
Before USP was created – and in the early years of USP’s existence – medicines were mostly made without consistency by individuals in apothecaries; the dosing levels and the quality of the ingredients often varied greatly, which could harm patients. Today in the U.S., we can have confidence in the medicines we take, thanks to the work of the U.S. Food & Drug Administration and the Good Manufacturing Procedures followed by the drug manufacturing industry, with support from the quality standards USP develops with our partners.
Our collective knowledge about medicines has grown exponentially over time. This knowledge, accumulated over the years, and continuously reviewed and discussed, has been compiled in a variety of formats, including compendia, which are used by pharmaceutical manufacturers, health policy makers, regulatory bodies, and healthcare practitioners. Compendia of pharmaceutical knowledge also may be referred to as “pharmacopeia,” and nearly every country has designated at least one as the basis for consistent drug manufacturing.
USP publishes several compendia, which contain descriptions, tests and methods to help ensure the quality of drugs, foods and dietary supplements:U.S. Pharmacopeia-National Formulary (USP-NF)
Enforced by the U.S. government, USP’s public drug standards help regulators and manufacturers ensure that safe, high-quality medicines make their way to consumers. When “compendial standards” refer to pharmaceutical standards in the USP-NF, this means the official quality standards to be used for all drugs sold in the U.S. marketplace. Compendial drug standards are also known as pharmacopeial standards, and the term is used to describe the quality standards contained in USP–NF and other pharmacopeias around the world.
Paired with USP’s reference standards – pure samples of materials used for comparison to manufacturer’s own materials – USP quality standards help ensure that drugs can be made consistently.Food Chemicals Codex (FCC)
Containing standards for the purity and quality of food ingredients, the FCC is used throughout the world to help manufacturers ensure the ingredients they produce, procure and use are of high purity and quality.
Knowing that food ingredients are authentic is key in preventing food fraud, a pervasive problem in the food industry. Food fraud causes economic and reputational losses to manufacturers that have been victim to it, and can cause serious public health consequences to consumers, especially when it relates to unknown allergens and contaminants introduced into otherwise safe foods. FCC monographs provide blueprints for ingredient quality and authenticity and are a valuable tool in the fight against food fraud.Dietary Supplements Compendium (DSC)
Used worldwide, and much like the FCC, the DSC provides quality standards to help manufacturers ensure the identity, potency and purity of their dietary supplement products.
Dietary supplements are widely used around the world, and because their regulation differs greatly from country to country, having public standards to establish their quality is extremely important. Dietary supplements and their ingredients also are vulnerable to adulteration, and the DSC is a tool that helps assure ingredient authenticity, increasing confidence that dietary supplements are free of contaminants and adulteration with other drugs.Herbal Medicines Compendium (HMC)
The HMC contains standards for herbal ingredients that have been approved by a national authority for use in herbal medicines or are included in a national pharmacopeia. HMC monographs provide the definition of an herbal ingredient along with the analytical test procedures and acceptance criteria for specified tests.Compounding Compendium
Used by practitioners when compounding medicines, the Compounding Compendium contains all the compounding-related standards from the USP–NF, including more than 170 compounding monographs, as well as over 40 supporting general chapters such as those on Sterile and Non-Sterile Pharmaceutical Compounding.What Makes USP Compendia Unique?
USP’s status as the only non-governmental pharmacopeia, and the fact that our standards are set by independent volunteer experts from around the world, make the USP compendia unique in their ability to safeguard the quality of medicines, dietary supplements and food ingredients.
Public input is crucial to our open and collaborative development process, and we engage with stakeholders throughout. Our quality standards are developed with input from government representatives and independent experts – including scientists, academicians, practitioners, and other professionals who volunteer their expertise. Proposed standards are made available for public review and comment in Pharmacopeial Forum (PF), the Food Chemicals Codex Forum (FCCF), or on the HMC website before they are finalized by a USP Expert Committee.
The public standards we create are critical to constructing and reinforcing the foundation for quality in health and healthcare, and are used in more than 140 countries around the world. Collaborating with the world’s top health and science experts — including 800 volunteers from universities, nonprofits, industry and government — USP sets the bar for manufacturing and distributing quality medicines, dietary supplements and foods around the globe. We continuously revise our portfolio to keep it current and ensure quality products are available worldwide, so we can help protect and improve the health of people everywhere.Claudia Costabile Wed, 11/22/2017 - 09:51 Global Health
In conversations about the role of quality standards in public health, you might come across the words “compendia” and “compendial.” At USP, terms like “compendial approaches,” “compendial standards,” and “compendial tools” are part of our everyday vocabulary. But their meaning can be a bit of a mystery to people who work outside of the pharmaceutical industry and regulatory bodies.Global Health
Men’s Health Month, aka June, was established in 1994 as a way to raise awareness about the various health risks that males face in their lives. Men are more likely than women to smoke and drink alcohol, put off regular medical checkups, and – let’s face it guys - make less than healthy choices. Men also die about five years earlier than women. The leading cause of death of U.S. men (25%) is cardiovascular disease. According to the American Heart Association, a third of all men in the nation – more than 39 million – suffer from some type of heart or vascular problem, and nearly 400,000 of us die every year.The Big Three of Men's Health
It’s no secret that there are three big keys to preventing many health risks: physical activity, healthy diet, and weight loss. The American Heart Association, for example, recommends at least 150 minutes of light physical activity each week, like going for a walk, or 75 minutes of vigorous activity per week, like jogging or biking.
Some men use dietary supplements to help them achieve their health goals, with many good results. However, some scientists are becoming increasingly cautious about these supplements because of the way they can impact the liver. A recent study found that the number of liver injuries linked to dietary supplements have nearly tripled in ten years, from 7% in 2004, to 20% in 2014. Half of those cases were attributed to weight-loss and bodybuilding products that contained anabolic steroids and green tea extract. Some men's health supplements contained other undisclosed ingredients, such as banned, untested and prescription drugs.
So if you’re ever browsing the aisles for diet pills, be aware that some of those weight-loss and muscle-building supplements could pose a serious threat to your liver. In fact, research shows that within the three named categories – weight-loss, muscle-building, and sexual enhancement – tainted supplements may actually outnumber drug-free products.
One of the best ways to avoid buying adulterated supplements is to stick with products that have the USP Verified Mark on their label. The USP Verified Mark is awarded to dietary supplement products that successfully undergo the strict testing criteria of its voluntary Dietary Supplements Verification Program. USP inspects how the supplements are made, what methods are used to test both the ingredients and the final products, and whether those tests are capable of identifying harmful contaminants. Then USP tests the supplements against federally recognized USP-NF standards. Since the program's inception in 2001, the USP Verified Mark has appeared on more than 750 million labels/packages of dietary supplements.
Find out more about the USP Dietary Supplements Verification Program.
Happy men's health month and may all your months be healthy!Robert Gutnikoff Fri, 06/30/2017 - 10:29 Dietary Supplements
Men’s Health Month raises awareness about health risks that men face. One way to avoid adulterated supplements is to seek out USP Verified Mark on labels.Dietary Supplements
There’s a good chance your diet leaves you nutritionally deficient. You may take (or may be thinking about taking) a supplement to make up the deficiency.
Dietary supplements are not regulated the same way drugs are regulated, so it’s important to know what you’ll be buying before you head to the store.
USP Verified Dietary Supplements are rigorously tested and audited using the four P’s of quality: Positive Identity, Potency, Purity, and Performance. Explore this infographic to learn more, and visit Quality Supplements to find out what supplements are USP Verified.USP Staff Thu, 09/15/2016 - 15:59 Dietary Supplements
USP breaks down its process for helping to ensure dietary supplement quality in this infographic.Dietary Supplements
Dietary supplements, used regularly by about half of U.S. adults, can add significant amounts of nutrients and other ingredients to your diet. While supplements come in many different forms including tablets, capsules, powders and liquids, any product labeled as a dietary supplement must carry a Supplement Facts label that lists its contents and other added ingredients (such as fillers, binders and flavorings) as well as directions for use, health-related claims and any cautions.
USP has created the following infographic as a quick guide to help you find and understand the most important features of a supplement label.
Learn more about dietary supplements and why quality matters at http://www.quality-supplements.orgUSP Staff Fri, 08/26/2016 - 09:27 Dietary Supplements
In 2015 and 2016, USP launched a series of “roundtable” events designed to engage industry in discussion of issues that present particular scientific challenges. The roundtables are a precursor to the standards setting process and are intended to help inform USP’s work so that we can better address our customers’ unmet needs. Topics have included probiotics, medical cannabis and, most recently, gummy dietary supplements.
Like probiotics, the popularity and availability of gummy dietary supplements in the marketplace continues to grow. According to recent reports, gummy dietary supplements now account for 9.8% of all dietary supplements (ranking third behind pills and softgels) and sales are forecasted to grow from $625 million to $1 billion by 2017. Their soft texture and flavorings make them an appealing choice for consumers, especially those who have difficulty swallowing pills or digesting other supplement forms, such as children or older adults. However, given their unique manufacturing process, gummy dietary supplements can present some particular challenges in terms of quality.
In its continuous effort to benefit public health by supporting quality in the marketplace, USP’s roundtable discussion gathered industry leaders to get their input on developing quality standards for gummy dietary supplements. About 40 stakeholders representing major gummy manufacturers, ingredient manufacturers, contract laboratories, and trade associations were invited to participate in the event held March 3, 2016 in Rockville, MD.Discussion of Technical and Quality Challenges and Considerations
Participants shared their views on technical and quality challenges in manufacturing as well as scientific and public health considerations related to the future development of USP quality standards for gummy dietary supplements. Key discussion topics included:
• Raw Materials and Manufacturing: Participants provided insight into the challenges they face related to sourcing compendial-grade raw materials and harmonization of raw material qualities among gummy ingredient suppliers. Concerns were raised that too stringent quality specifications may inhibit product innovation. Some noted that at the beginning that USP may need to develop standards for the most common type of gummy in the US market—starch molded gummies with gelatin. In addition, challenges in variations in weight and ingredient overages in the manufacturing process were also discussed.
• Quality Parameters in Product Specification: To help USP determine suitable quality parameters (i.e., analytical methods and acceptance criteria for identification, strength, performance, specific tests, and limits for contaminants) to consider for future monograph development, participants shared the quality parameters and acceptance criteria currently practiced in industry. These include weight variation, appearance, organoleptic test, water activity, titratable acidity, moisture, loss on drying, Brix, and/or pH, and microbial testing. The discussion also addressed the applicability of dissolution and disintegration performance testing to gummy dietary supplements and current expiration dating practices.
• Testing Procedures: Dietary supplement cGMP mandates that manufacturers use scientifically-valid methods for process and quality control in the manufacturing process. USP encouraged manufacturers to share their testing methods to help inform future USP standards development activity relating to gummy dietary supplements. Participants shared various techniques for extracting ingredients for sample preparation (e.g., freezing, melting, grinding and slicing) and a variety of analytical methods for testing ingredient strength, including , high-performance liquid chromatography (HPLC), ultra-high performance liquid, inductively coupled plasma-optical emission spectroscopy (OES), and mass spectrometry (MS). In addition, USP provided an update on the development of testing procedures that it has conducted for gummy dietary supplements with oil soluble vitamins, water soluble vitamins, and minerals.
• Shipping, Handling and Labeling: Participants shared industry-wide challenges related to shipping at the manufacturer level as well as storing and handling at the retail level. These challenges may affect the quality, integrity and the shelf life of gummy dietary supplements and may impact subsequent standardization of such products.
They also provided their opinion regarding the labeling of gummy dietary supplement products. This included industry feedback as well as an update from USP on proposing alternative compendial nomenclature to use in lieu of “gummy,” a term that FDA has noted may pose a safety concern as it can be confused with candy and food connotations in pharmaceuticals. USP noted that they may form a working group to discuss the issue and determine the best solution.Learn More and Get Involved in the Development of USP Standards for Gummy Dietary Supplements
A full summary of this roundtable discussion with additional details and outcomes can be found in “USP Collaborates with Industry to Develop Quality Standards of Gummy Supplements” from the March 2016 USP Dietary Supplements E-Newsletter. Building on knowledge gained from the roundtable, USP continues to ask for industry input regarding gummy dietary supplements. Priority needs include information on the following:
• Ingredient overages,
• Piece weight variation, and
• Validated testing procedures.
If you are interested in contributing to this effort, please contact Seong Jae Yoo, Ph.D., USP Scientific Liaison, Dietary Supplements and Herbal Medicines, at firstname.lastname@example.org. To stay informed of USP dietary supplement news and activities, subscribe to the quarterly newsletter.USP Staff Fri, 04/08/2016 - 09:52 Dietary Supplements
Stakeholders representing major gummy manufacturers, ingredient manufacturers, contract laboratories, and trade associations recently participated in a USP roundtable discussion on gummy dietary supplements. They shared their views on technical and quality challenges in manufacturing as well as scientific and public health considerations related to the future development of USP quality standards for gummy dietary supplements.Dietary Supplements
Reference Standards from the United States Pharmacopeial Convention (USP) are highly characterized chemical specimens—pure materials or mixtures of chemicals that have been tested in multiple laboratories—intended for quality control use in conducting assays and tests in USP’s documentary standards for drugs in the United States Pharmacopeia–National Formulary (USP–NF), for dietary supplements in the USP–NF and Dietary Supplements Compendium, and for foods in the Food Chemicals Codex. They can help ensure compliance with the official, FDA-enforceable quality requirements in the USP–NF. USP Reference Standards also lend themselves to other applications, including measurements required to obtain accurate and reproducible results in modern chromatographic and spectrophotometric methods.
USP currently offers more than 3,500 Reference Standards, including materials for drug substances, biologics, excipients, dietary supplements, food ingredients, impurities, degradation products, reagents, and performance verification standards.
To help users of USP Reference Standards locate and apply materials relevant to their work, USP offers these convenient tools and resources:
1. Online Catalog: A complete listing of USP Reference Standards along with lot, date, and ordering information is available online in downloadable XLS and PDF formats. Listings are updated daily to ensure you have current and accurate information.
2. Frequently Asked Questions: The Reference Standards FAQs webpage offers answers to commonly asked user questions, including queries about technical data sheets, labeled value (purity/potency), use and application, shipping, availability and validity.
3. Usage and Storage Information: This guidance provides important information regarding suitability for use, understanding directions on the label and in USP–NF, storage, weighing, drying and dissolution—PVT ranges.
4. Safety Data Sheets Online: This online searchable index lets you download, save and print safety data sheets for the entire catalog of USP Reference Standards.
5. Notices and Information on New or Upcoming Reference Standards Releases:
- Reference Standards Under Development: View a list of never-before-released Reference Standards currently under development at USP and their anticipated release dates
- Notification of New Releases: Sign up to receive an email when a new ever-before-released Reference Standard becomes available.
- Monthly E-Mail Notice: Our monthly email notice features important Reference Standards information including the estimated availability for out of stock items, items with recent or pending valid use dates, and helpful tips.
Discover convenient tools and helpful tips related to using USP Reference Standards in your work. USP Reference Standards are intended for quality control use in conducting assays and tests in USP’s documentary standards for drugs, dietary supplements, and foods.Pharmaceuticals
Quality plays an integral role in connecting medical research and manufacturing to healthcare practice and consumers. The growing study of the microbiome and the potential health benefits of probiotics offers a particularly timely and illustrative example.
Ongoing research into the gut-brain connection has pointed to specific strains of probiotics as a potential treatment for a variety of conditions and symptoms. This is exciting news indeed for healthcare practitioners and consumers. But it is important to note that the research results are tied to specific strains of probiotics and is still evolving.
Any excitement generated by these results is dampened somewhat by another study into the quality of commercially available probiotic products.
In a study on Validating Bifidobacterial Species and Subspecies Identity in Commercially Available Probiotic Products published in the journal Pediatric Research in December 2015, Lewis, et al., tested commercially available products and found “only 1 of the 16 probiotics perfectly matched its bifidobacterial label claims in all samples tested, and both pill-to-pill and lot-to-lot variation were observed.” From this they concluded, “the prevalence of misidentified bifidobacteria in these products is cause for concern for those involved in clinical trials and consumers of probiotic products.”
Probiotic quality standards for specific strains could be the unifying thread that connects clinical research to healthcare practitioners, consumers/patients and industry. To date, USP has developed quality standards/monographs for 8 specific probiotic strains and recently met with a roundtable of key stakeholders to discuss efforts going forward.
Learn how USP standards for these probiotics would benefit consumers, academia and industry in this recent article by USP Scientific Liaison Seong Jae Yoo in Natural Products Insider: www.naturalproductsinsider.com/blogs/supplement-perspectives/2016/01/usp-probiotic-standards-would-benefit-consumers-a.aspx.
Anne Bell Thu, 01/21/2016 - 08:16 Food
Quality plays an integral role in connecting medical research and manufacturing to healthcare practice and consumers. The growing study of the microbiome and the potential health benefits of probiotics offers a particularly timely and illustrative example. Learn about the quality standards USP has developed for probiotics and how they could be the unifying thread connecting clinical research to academia, industry and patients/consumers.Food
Thank you for helping Quality Matters spread the word in 2015 about USP quality standards and the important role our work plays in industry, public health and lives around the world.
Over the past year, we have published more than 50 posts on timely topics central to our mission—including biologics, dietary supplement adulteration, compounded medicines, and combating poor drug quality in developing countries. Authored by USP leadership and staff, member organizations and volunteers, our blogs have aimed to provide a variety of perspectives that represent the diversity of our work and its impact.
In addition, we have launched new series, such as the “USP Q&A” and “5 Things You Should Know,” that highlight new tools and information to help facilitate the work of analytical scientists working in the pharmaceutical, foods and dietary supplement fields as well as practitioners and healthcare professionals who use our standards to provide quality care to their patients.
While we feel that all Quality Matters blog posts are important, the following articles are the ones that you, our readers, found to be the most engaging and useful in 2015.
Again, we thank you for your interest and welcome your comments and ideas for future blogs (please use the commenting tool below or email suggestions to email@example.com). On behalf of USP and Quality Matters, best wishes for a prosperous and healthy New Year!
- “Removing Barriers to Improve Drug Quality in Africa”: Patrick Lukulay, USP’s VP of GHIP–Africa, discusses plans to leverage his new post in Accra, Ghana to advance pharmaceutical quality in Africa. Countering inadequacies in drug quality through advocacy and working to help build an enabling environment that can sustain systems for effective regulation of medical products, he says, are needed for this to happen.
- “USP Q&A: Dissolution, Disintegration and Drug Release Tests”: Dissolution, disintegration and drug release tests are important tools during the entire lifecycle of a drug product, from early development throughout its shelf life. USP’s Margareth Marques, Ph.D., provides answers to common questions and insight into standards and resources for these tests.
- “Pharmacopeial Forum: 5 Things You Should Know”: Pharmacopeial Forum (PF) is the vehicle through which USP publishes proposed revisions to USP–NF standards for public review and comment. Learn about PF and how you can use it to help shape standards for drugs, excipients and dietary supplements.
- “What Is a Reference Standard?” : Developing documentary standards and Reference Standards is the core of what we do at USP. These standards help to assess the quality, strength, identity, and purity of chemical medicines, food chemicals and ingredients, dietary supplements, and biologics, among other items. Learn about the types of USP standards, how they are referenced in U.S. law, where they are used, and more.
- “Elemental Impurities—Their Impact on Drug Quality”: Today, approximately 80% of all active pharmaceutical ingredients in medicines sold in the U.S. are manufactured in another part of the world. While manufacturers have to ensure the quality and consistency of ingredients that go into final pharmaceutical products, they must also employ measures for the proper control of unwanted impurities in drugs and drug ingredients.
USP Staff Tue, 12/29/2015 - 09:11 USP Leadership
Thank you for helping Quality Matters spread the word in 2015 about USP quality standards and the important role our work plays in industry, public health and lives around the world. These five posts are the ones that you, our readers, found to be the most engaging and useful in 2015.USP Leadership
1. What Is Pharmacopeial Forum and Where Can It Be Found?
Did you know standards for drugs, excipients, and dietary supplements found in the United States Pharmacopeia–National Formulary (USP–NF) are continuously revised through a process involving public participation? The vehicle through which the United States Pharmacopeial Convention (USP) publishes its proposed standards revisions for public review and comment is called Pharmacopeial Forum (PF).
First published as a print journal in 1975, PF is now a free, bimonthly online publication that can be accessed here: www.usp.org/usp-nf/pharmacopeial-forum.
2. Types of Revisions and Information Available for Public Review and Comment in PF
Proposed Revisions: Generally referred to as in-process revisions, these are new or revised USP–NF standards targeted for adoption through USP’s Standard Revision Process, which calls for publication of a proposed revision in PF for a 90-day notice and comment period. After the comment period and subsequent review of comments and approval by the relevant USP Expert Committee, the official standard is published in the next available USP–NF or Supplement. If comments received are significant, or if the Expert Committee's consideration of comments results in significant additional changes, the Expert Committee may determine that republishing in PF is necessary prior to the revision becoming official.
Proposed Interim Revision Announcements (IRAs): IRAs are revisions that become official through an accelerated process in accordance with USP’s Guideline on Accelerated Revisions. IRAs allow for a revision to become official prior to the next USP–NF or Supplement. IRAs are first presented for a 90-day public comment period in the Proposed Interim Revision Announcement section of the PF. (NOTE: Final IRAs, as well as Errata, and Revision Bulletins, which also are defined in the Accelerated Revision Guideline, are not published in PF but can be found online here.)
Stage 4 Harmonization: PF also features revision proposals from the Pharmacopoeial Discussion Group (PDG), which comprises the European Pharmacopoeia, the Japanese Pharmacopoeia, and USP. The Stage 4 draft and the briefing are published in the forum of each pharmacopeia for public comment.
Stimuli to the Revision Process: Through PF, you can also comment on Stimuli, articles on standards development topics authored by the USP Council of Experts, USP staff, or other interested parties on which USP desires public input prior to further development.
3. How to Comment on Revisions via PF
Log in to PF to view proposed revisions in the most current volume and edition of PF. (Note: a one-time registration is required.)
Review material and prepare your comments. For comments that request the accommodation of an FDA-approved article in a revision, a general description of the types and amount of information expected in a Request for Revision is available in the Guideline for Submitting Requests for Revision to the USP–NF.
Submit your comments within 90 days of the PF publication in which the standard was proposed (or per the comment deadline listed in the Briefing section). To submit comments on in-process revisions, IRAs and Stage 4 proposals:
- Click on the Email Comments (envelope) icon at the top right corner of the screen on the proposed revision page.
- Click on the contact name hyperlink. An email window will open up in your default email client.
- Create and send your email, attaching any related documents, as needed.
- You will receive a confirmation email for your submission.
To comment on Stimuli articles, please see the footnotes section of each article for contact and submission information.
4. What Happens to Submitted Comments?
USP welcomes comments and data on proposed revisions. A summary of comments received, along with USP’s responses, will be published in the Proposal Status/Commentary section of the USP website. The chart below shows the public review and comment process and its relationship to standards development. (Click on image for enlarged view.)
5. Tools to help users view content in the latest PF
USP offers several resources to help users quickly view and find topics in the latest edition of PF:
- The PF Table of Contents with hyperlinks can be viewed and accessed from inside the online publication and publicly on the USP website: www.usp.org/usp-nf/pharmacopeial-forum/pf-table-contents.
- The PF Alert—a pre-recorded complimentary video from USP Pharmacopeial Education—allows users to view highlights of selected topics in the current PF. A new video is produced bimonthly with the release of each new PF. Learn more and access the latest PF Alert at https://uspharmacopeia.csod.com.
Pharmacopeial Forum (PF) is the vehicle through which USP publishes proposed revisions to USP–NF standards for public review and comment. Learn about PF and how you can use it to help shape standards for drugs, excipients and dietary supplements.Pharmaceuticals