IACP News Roundup - April 27, 2018

IACP News Roundup - April 27, 2018

To keep you informed on all of IACP member-driven initiatives and latest legislative & regulatory updates, IACP has debuted a weekly News Roundup ! Check out this week's report below, and email us at [email protected] with questions.

ABOUT

Member-Driven Initiatives

IACP is committed to making sure you are kept up to date on all the member-driven initiatives that we are working on and the latest in industry news. This week was busy, we had a lot of information to share - I'm sensing a theme here, we seem to say this every week, but every week it's true!

There is still time to send in your Video Competition submissions. The deadline is Monday, April 30, 2018.

The new Executive Membership is available, and we now have fourteen Executive Members! We are thrilled that these IACP VIPs have taken advantage of the opportunity to upgrade their membership. Will you be next? Don't forget that by upgrading your membership, you can attend CCH for FREE! The benefits start right away!

Don't forget there are multiple ways that members can attend CCH for FREE or for a greatly reduced price. It is more important than ever that you walk the Halls of Congress this year to help preserve patient access! Take a look at the competitions available and jump on in!

Keep an eye on your inbox, because we have a few more programs and more highlights to share with you next week!

Check out the video from Congressman Griffith

explaining why

YOU NEED to be at CCH this year!

To help keep up with IACP. We want to make sure you can connect with us on all our social media channels. Please like, follow, share and comment on our social media posts! Here is a quick list of links and all the places you can interact with us!

IACP

IACP Students

IACP

EVP and IACP Ambassador Tracking

The NEW IACP Ambassador Program, created by the IACP Membership Committee and chaired by Doug Yoch, has been announced and we have already received two applications from interested IACP Members. The IACP Ambassador Program give IACP members an opportunity to represent IACP as an ambassador at specific conferences and events. In return, IACP Ambassadors will receive discounts on registration to IACP events and other benefits. This is one more way we are listening to your feedback and requests! We heard that you want to be able to represent IACP more at other conferences and events by speaking and we are answering your call! For more information click here.

Doug Yoch, IACP Board Member and IACP Membership Committee Chair recently spoke to pharmacy students at University of South Carolina (USC) during their Pharmacy Day. Doug, an alumnus of USC, had an opportunity to share more about IACP and why membership was important. While he was there he got 15 new pharmacy student members signed. Thank you, Doug!

Lauren Aller, IACP Member, spoke and exhibited for IACP at the LP3 Network Student Compounding Competition held in Aventura, FL on March 17th - 18th. What a wonderful opportunity to work with students and share more about IACP and what incredible benefits IACP offer to students including a FREE student membership!

IACP Executive Vice President and USP Delegate, Cynthia Blankenship, attended the USP Compounding Expert Committee (CEC) meeting set for April 11th. The USP CEC met to develop and revise existing compounding-related general chapters describing quality and practice standards for compounding sterile and nonsterile preparation. The CEC will develop compounded preparation monographs containing formulations for both human and veterinary patients.

IACP attended the PCCA ACT Legislative Conference in Washington D.C. on April 18th - 19th as well. The conference began with a half day of educational programming on Wednesday afternoon followed by an opening dinner, a legislative breakfast on Thursday followed by Congressional visits and a closing reception.

Member Initiatives

IACP Initiatives - Storm the Hill at CCH!

Storm the Hill with Your Colleagues in Washington, DC and Share Your Patients' Voices with Capitol Hill to Preserve Patient Access to Compounded Medications!

Join us in Washington, D.C. for the

24th Annual Compounders on Capitol Hill (CCH), June 23-26, 2018 at the Renaissance Washington D.C. Downtown Hotel.

Register today for CCH 2018 to walk the halls of Congress to protect, promote, and advanced the art of compounding. This is not the time to sit on the sidelines, we need you and your voice at CCH more than ever!

IACP Launches Competitions for CCH with Amazing Awards and Prizes!

CCH 2018 Overall Champion and State Captain Competition

GET ACTIVE, GET INVOLVED, GET ENGAGED!

IACP NEEDS you at #CCH2018 now, more than ever! We are launching a Competition to encourage IACP members from the United States to attend CCH 2018.

This competition is as simple as telling others why attending CCH is so important . Compounding is personal and so are the stories from you and your patients. Your Voice Matters - Your Vote Matters: The most common misconception is that pharmacists don't understand how powerful their voice is and what makes them different from their opposition. YOU have something that no one else has - YOUR vote which spans in every Congressional district. You, your patients, and the providers you work with are constituents - and, constituents vote during elections, they tell their co-workers, families, and friends how to vote as well. In times like these when our opposition is actively working against us on a daily basis - it's important to keep in mind that none of our opposition has this benefit that you have - but you have to make that benefit count. It's what makes you different and it's what makes YOUR presence as we Storm the Hill and walk the Halls of Congress at CCH so important. The stakes are too high, and this is not the time to sit on the sidelines and hope that someone else will represent your voice. Join your colleagues in preserving patient access and join us in the Halls of Congress to deliver this messaging like ONLY YOU can.

Here's How the Competition Works:

We are asking each member to tell their colleagues and friends, to join us in Washington, D.C. for the 24th Annual Compounders on Capitol Hill (CCH), June 23-26, 2018 at the Renaissance Washington D.C. Downtown Hotel .

Once they register, we have added an additional question to the CCH 2018 registration form to allow your invitee to place your name as their CCH reference. This is where you get to shine!

The member that gets the most people to CCH will be our overall Champion and win a free CCH registration!

In addition, the member that is able to get the most people from their state to CCH, will win the IACP State Captain Award and receive half off their CCH registration! The amount of people IACP members are able to get to attend CCH from a state will be based on percentages of population of each state to ensure everyone has an equal opportunity to win this award!

Competition Rules:

You must be a current member of IACP

Your invitee must include your name in the registration form under the Attendee Information section. (How did you hear about Compounders on Capitol Hill?)

In order to qualify all registrations must be received by the final advanced discount deadline, May 14, 2018. Click here to register TODAY!


IACP Executive Vice President Cynthia Blankenship, Esq.

Your Presence is Needed at CCH!

As a former Congressional staffer in the U.S. Senate and U.S. House of Representatives, I am often asked why storming the Hill during

Compounders on Capitol Hill (CCH) is so important and whether it's worth your time away from patients and your pharmacy. My answer is a resounding YES and here's why.

I've been on the other side of the table from you with the Senator and Congressman for many years during fly-ins on the Hill. Every other day, we met with lobbyists and attorneys and not to say that isn't important - but no one can represent YOUR voice and the voices of your patients like YOU. If you aren't showing up, you are gambling that someone else will represent your voice, your passion for preserving your industry and patient access, and share your personal stories - and that's a dangerous gamble to make. We have an incredible government affairs team at IACP that we are grateful for, but as they would also admit as former Congressional staffers - no voice is as powerful as YOUR voice. Compounding is personal and so are your stories and the stories of your patients.

Your Voice Matters - Your Vote Matters: The most common misconception I saw as a Congressional staffer was that pharmacists didn't understand how powerful their voice was and what makes them different from their opposition. YOU have something that no one else has - YOUR vote which spans in every Congressional district. You are a constituent; your patients are constituents and the providers you work with are constituents - and, constituents vote during elections, they tell those they work with, their families, and their friends how to vote as well. In times like these when our opposition is actively working against us on a daily basis - it's important to keep in mind that none of our opposition has this benefit that you have - but you have to make that benefit count. It's what makes you different and it's what makes YOUR presence as we Storm the Hill and walk the Halls of Congress at CCH so important.

If you are new to Hill day or feel that you want to ensure someone that is a Hill veteran goes to the Hill with you, don't let this hold you back! We have added an option on the registration form where you can let us know! We have a vast army of volunteers from former Congressional staff, Corporate Members, and other Hill day veterans lined up ready to storm the hill with you!

We are also going to shake it up this year with some incredible competitions coming your way for those who get the most folks to CCH! We have some amazing prizes and awards in store! Stay tuned next week for the launch of these competitions and more information! No one's voice is more powerful than your voice on Capitol Hill and in getting your colleagues to join us at CCH!

Also, please note that in order to ensure you are able to attend all your scheduled meetings, please do not schedule your flight before 6 p.m. on Tuesday, June 26^th!

So, tell your colleagues and tell your friends to j oin us in Washington, D.C. for the 24th Annual Compounders on Capitol Hill (CCH), June 23-26, 2018 at the Renaissance Washington D.C. Downtown Hotel.

The stakes are too high, and this is not the time to sit on the sidelines and hope that someone else will represent your voice. Join your colleagues in preserving patient access and join us in the Halls of Congress to deliver this messaging like ONLY YOU can.

Please email [email protected] if you have any questions, OR if you'd like to get more involved with IACP! We'd love your help in achieving these 2018 goals!

IACP loves our Committee Chairs and Members! We couldn't do it without you. If you are interested in joining a committee, let us know! Please email Jennifer Petska at [email protected] for more information.

Registration for Compounders on Capitol Hill is

NOW OPEN!

Compounders on Capitol Hill (CCH) brings together the top-level compounding pharmacists and technicians from across the country with the same goal - to protect pharmacy compounding. Network and Reconnect with old friends and meet new colleagues who share your passion and interest in protecting, promoting and advancing pharmacy compounding!

The 24th Annual Compounders on Capitol Hill will be held June 23-26, 2018 at the Renaissance Washington DC Downtown Hotel. With more than 400 expected attendees in 2018.

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NEWSROOM

FDA Nomination Slide Posting

FDA is planning to post the nominator slides from past PCAC meetings. Moving forward, FDA will be posting nominator slides shortly after the meeting along with all other post-meeting documents.

DQSA Coalition Meeting with FDA

The DQSA Coalition will be meeting with FDA on Monday, April 30th at FDA's White Oak facility to discuss patient access to compounded medications issues. IACP's Vice President, Shawn Hodges and IACP Board Member, A.J. Day will be presenting during the meeting.

IACP's Initial Comments Regarding the FDA Press Release, Guidance document and additional FDA comments

IACP's general impression is that the FDA's draft guidance, "Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act", is a disincentive for anybody to register as a 503B, which makes it contrary to Commissioner Gottlieb's statements before the House E&C committee. As mentioned in the current guidance document lines 47-53,

"Drug products compounded under the conditions in section 503B are not exempt from current good manufacturing practice (CGMP) requirements in section 501(a)(2)(B) of the FD&C Act.5 Outsourcing facilities are also subject to FDA inspections according to a risk-based schedule, specific adverse event reporting requirements, and other conditions that help to mitigate the risks of the drug products they compound.6 Outsourcing facilities may or may not obtain prescriptions for identified individual patients and can, therefore, distribute compounded drugs to healthcare practitioners for "office stock," to hold in their offices in advance of patient need. 7"

Within this framework, it is difficult to follow FDA's concerns about sources of pure ingredients (what FDA refers to as "bulk"). 503B Outsourcing Facilities are required to purchase all ingredients according to statutory requirements, including that the pure ingredient manufacturers are FDA-registered and comply with all applicable quality standards. Since FDA inspects the pure ingredient manufacturers and the outsourcing facilities to hold them accountable to those standards, the statements in this draft guidance that question the quality of the pure ingredients used by outsourcing facilities vs. those in FDA-approved drugs are false and misleading. To read the full statement click here.

To read the guidance document "Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act." Click here.
Statement from FDA Commissioner Scott Gottlieb, M.D., on a key step in advancing FDA's oversight of drug compounding and implementing new laws governing outsourcing facilities. Click here.

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FDA - Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for testimony before a U.S. Senate Committee on Appropriations on FDA's Fiscal Year 2019 budget

Healio - FDA draft guidance on drug compounding may limit access to affordable medications

The FDA has introduced draft guidance that, if finalized, would expand the agency's oversight of drug compounding and restrict the production of compounded drugs in FDA-registered outsourcing facilities.
Although the guidance - which is open for public comment until the end of May - aims to protect patients from potentially harmful drugs, there is concern that the proposed regulations may decrease patients' access to affordable treatment alternatives to FDA-approved products.
Moreover, because the more stringent regulations apply only to drug compounding facilities that are registered under the FDA, some argue the guidance could discourage facilities to work with the agency, thereby resulting in more drugs that are developed under lower compounding standards.

The FDA defines drug compounding as a practice in which a licensed pharmacist, physician or individual under the supervision of a licensed pharmacist modifies the ingredients of a drug to create a treatment for an individual patient whose needs cannot be fulfilled by an FDA-approved product. Drug compounders can either develop their products using an FDA-approved drug or a "bulk drug substance" that is identical to an active pharmaceutical ingredient (API). Bulk drug substances are often used when the FDA-approved product contains ingredients that are "inappropriate" for the patient, according to the FDA, However, the agency warns that using bulk drug substances in compounded drugs may be not be as safe for patients.

NABP News April 18, 2018 - Pew Indicates That Creating Incentives for Compounders Translates to Safer Drugs

One key component of the Drug Quality and Security Act (DQSA) is a provision directing FDA to set rules for shipment of compounded drugs over state lines. According to The Pew Charitable Trusts, robust implementation and enforcement of this provision is critical to ensuring that patients in a given state are protected when receiving drugs produced by a pharmacy in another state. Although many traditional compounders exclusively serve patients in their own state, others dispense products to patients elsewhere in the country.

The memorandum of understanding (MOU) provision of the DQSA is one way that the federal statute creates incentives for compounders to meet higher-quality standards, which translate into safer drugs, indicates a Pew fact sheet. Because traditional compounders can and do ship products across state lines, patients everywhere can be put at risk if any state has ineffective oversight. Federal law addresses this risk by offering states a choice:

*They may choose to enter into an MOU with FDA committing to certain oversight functions, after which pharmacies in those states may distribute a larger percentage of their compounded products interstate than pharmacies located in states that do not sign the MOU.

*Traditional compounders in states that do not sign the MOU are limited to distributing no more than 5% of their products interstate, limiting these compounders largely to in-state sales.

Pew notes that the MOU provision helps to prevent compounders from setting up shop in a state with relatively weak oversight and then sending large quantities of drugs all over the country. Compounders in states that commit to respond to complaints about drugs shipped out of the state, as outlined in the MOU, will be able to sell more product interstate than those in states that have not made such commitments. Therefore, the MOU provision creates an incentive for states to mitigate the risks of compounding, even if the patients at risk are out of state.

Other DOJ News

JD Supra - FDA Issues Draft Guidance on Bulk Substances for Compounding by Outsourcing Facilities

On March 23, 2018, the U.S. Food and Drug Administration (FDA) released draft guidance regarding the process through which it proposes to evaluate bulk drug substances nominated for use in compounding by outsourcing facilities registered under section 503B of the Federal Food, Drug and Cosmetic Act (FD&C Act). The FDA is accepting comments and suggestions on the draft guidance until May 25, 2018.

Section 503B permits the compounding of sterile drugs by registered "outsourcing facilities." Under Section 503B, outsourcing facilities may not compound a drug using a "bulk drug substance" (or, the active pharmaceutical ingredient that is intended for incorporation into a finished drug product) unless: (a) the bulk drug substance appears on a list established by the FDA ("Bulk List"), or (b) the drug to be compounded appears on the drug shortage list under the FD&C Act. The proposed guidance addresses the process that the FDA proposes to use to create the Bulk List.

JD Supra - The Effect of the DOJ Memo, "Limiting Use of Agency Guidance Documents in Affirmative Civil Enforcement Cases," On FDA Inspections of Compounding Pharmacies and Outsourcing Facilities

The United States Department of Justice - Associate Attorney General Brand Delivers Remarks to the Washington, D.C. Lawyers Chapter of the Federalist Society

See today's statement from Rachael Brand...in a speech

https://www.justice.gov/opa/speech/associate-attorney-general-brand-delivers-remarks-washington-dc-lawyers-chapter

FDA Law Blog - Guidance on Guidance on Guidance

Federal Register - Requests for Nominations: Pharmacy Compounding Advisory Committee

FDA - Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA's efforts to enhance the patient perspective and experience in drug development and review

FDA Releases Two User Fee Related Implementation Plans

Today, the Food and Drug Administration is releasing two user fee related implementation plans - "Resource Capacity Planning & Modernized Time Reporting Implementation Plan" and the "Benefit-Risk Assessment in Drug Regulatory Decision-Making Implementation Plan." These plans fulfill goals set forth during the latest reauthorization of PDUFA.

The "Resource Capacity Planning & Modernized Time Reporting Implementation Plan" outlines an approach to develop capabilities that will help ensure that the FDA is making optimal use of its user fee financial resources to maximize its ability to efficiently and effectively deliver on its commitments to the public. Through the development of these capabilities, FDA will be able to build more systematic, data-driven, and repeatable processes to better understand and anticipate its current and future resource demands, enabling FDA to more proactively ensure its organizational components are optimally resourced.

FDA plans to host annual public meetings, beginning in 2019, to engage the public in discussions regarding its progress in the development of its resource capacity planning and modernized time reporting capabilities. The FDA will welcome public comment regarding its approach and progress at these meetings.

Also, issued today is the "Benefit Risk Assessment in Drug Regulatory Decisions Making, Draft PDUFA VI Implementation Plan," which is an update to the 2013 implementation plan titled "Structured Approach to Benefit-Risk Assessment in Drug Regulatory Decision-Making." This plan offers an update on CDER's and CBER's actions in implementing FDA's Benefit-Risk Framework (BRF) into our regulatory review processes and documentation. It summarizes the third-party evaluation of FDA's implementation of the BRF. It outlines FDA's commitments under PDUFA VI, including publication of a draft guidance on benefit-risk assessment for new drugs and biologics. Among other topics, this draft guidance will include discussion on how relevant patient experience data and related information may be used to inform benefit-risk assessment. FDA welcomes comments on this plan.

FDA hopes that availability of both plans will support enhanced transparency of, and efficiencies in, FDA processes for drug developers. By enhancing transparency and efficiencies, the agency aims to help bring FDA-approved drug products to patients as quickly as possible.

IACP Member Alerts

IACP Membership Video Competition Deadline is Coming Up! - April 19, 2018
Meet IACP's Board Members - Part Three - April 19, 2018
Don't miss the IACP COMP PAC Events during CCH! - April 18, 2018
IACP AdvanCE Webinar Program - Register TODAY! - April 18, 2018
Meet IACP's Board Members - Part Two - April 17, 2018
IACP Reveals TWO More NEW Membership Categories - Educational/Institutional and
Pharmacy Tech Student
- April 16, 2018
IACP Member Alert - NIOSH List Revision - Comment Deadline 4/16/18 - April 13, 2018
Meet IACP's Board Members - Part One - April 12, 2018
Congressman Morgan Griffith to Present at #CCH2018 - April 12, 2018
Attend CCH for FREE - April 11, 2018
IACP Committee Chairs Part Six - April 11, 2018
IACP Video Competition - April 9, 2018
IACP Progress Report - April 5, 2018
IACP COMP PAC Newsletter - April 3, 2018
IACP Thanks Two New Members to Upgrade to the NEW Executive Membership - March 29, 2018
YOU ARE INVITED: Congressman Chris Steward Reception - March 28, 2018
Storm the Hill for IACP at Compounders on Capitol Hill, June 23-26, 2018 - March 28, 2018
FDA Requests Nominations for Voting Members on PCAC - March 27, 2018
IACP Comments on FDA's Guidance Directed at 503B Outsourcing Facilities - March 27, 2018
IACP State Member Alert: California State Board of Pharmacy Meeting to Address PEW State Compounding Report and USP - March 26, 2018
IACP AdvanCE Webinar Program - March 26, 2018
FDA Releases Guidance Directed at 503B Outsourcing Facilities - March 23, 2018
UPDATE: President Trump Signs Spending Bill - March 23, 2018
UPDATE: President Trump Issues Veto Threat Moment Ago - IACP will keep you updated! - March 23, 2018
IACP Applauds Leadership of the U.S. Congress in Passing Omnibus Appropriations Legislation - March 23, 2018
YOU ARE INVITED: Congressman Chris Stewart Reception - March 21, 2018

CCH 2018 Overall Champion and State Captain Attendee Competition - March 20, 2018
IACP Reveals the IACP Ambassador Program - March 19, 2018
Storm the Hill for IACP at Compounders on Capitol Hill, June 23-26, 2018 - March 13, 2018

Corporate Member Tiers Revealed - March 12, 2018
IACP Thanks Second Member to Upgrade to Executive Membership - March 8, 2018
IACP Thanks First Member to Upgrade to the NEW Executive Membership - March 7, 2018
IACP Submits Comments to Kansas - March 5, 2018
Executive Member Reveal - March 5, 2018

IACP Member Newsletter

Capitol Connections Newsletter, April 6, 2018
Capitol Connections Newsletter, March 23, 2018
Capitol Connections Newsletter, March 9, 2018

Members News

2018 HR Achievement Awards

Utah Business Editors Apr 9, 2018

HR leaders are usually more accustomed to giving out kudos than receiving them. That's why we're delighted to turn the tables and give some stellar HR professionals the recognition they deserve.

Mrs. Heidi Humphries, Director of Human Resources of MedQuest Pharmacy was honored on April 9, 2018 at a reception with the 2018 HR Achievement Award from Utah Business Magazine. Heidi is a key member of the MedQuest Pharmacy team and does an incredible job of bringing in and supporting talented pharmacy professionals, many of these are IACP members themselves.

The NPA Congratulates New Board of Pharmacy Member

The NPA congratulates, Angie Svoboda, PharmD, as the newest member of the Nebraska Board of Pharmacy.

Dr. Svoboda is the Pharmacist-In-Charge at Good Life Pharmacy in Ord. She received her Doctor of Pharmacy from the University of Nebraska Medical Center College of Pharmacy and is an Associate Professor of the University of Nebraska College of Pharmacy, as well as a Fellow of the International Association of Compounding Pharmacists.

Dr. Svoboda replaced Board of Pharmacy member, Maggie Kucera, and now joins the other pharmacist members of the Board of Pharmacy: Sabrina Beck, Omaha; Patty Gollner, Hastings; and Ken Saunders, Omaha.

IACP Board Member, Erika Fallon was recently on an episode of Pharmacy Inspection Podcast and shared more about IACP and why it was important to be involved. Thank you, Erika!

INDUSTRY NEWS

Detroit News - Bills would let pharmacists tell customers best prices

A new package of legislation introduced in Congress would bar legal clauses that limit pharmacists from alerting patients to the cheapest way to pay for their prescriptions at the pharmacy counter.

The bipartisan bills would bar an insurer or pharmacy benefit manager from restricting a pharmacist's ability to disclose when a customer's prescription would cost less if they paid the cash price, rather than the amount of their health insurance copay.

The legislation was prompted by the practice of "clawbacks." That's when a patient's copay - often set by the pharmacy benefit manager - is more expensive than the total cost of the drug. The difference in cost is then "clawed back" by the insurer or pharmacy benefit manager.

PBM transparency, DIR fees are top priorities for pharmacists on Capitol Hill

https://www.specialtypharmacytimes.com/news/pbm-transparency-dir-fees-top-priorities-forpharmacists-on-capitol-hill

Lund Report - Compound Scores Key Win in Battle Against Antibiotic Resistance

Researchers at Oregon State University have made a key advance in the fight against drug resistance, crafting a compound that genetically neutralizes a widespread bacterial pathogen's ability to thwart antibiotics.

The findings are important because antibiotic resistance is a growing global threat, with the percentage of isolates with multidrug resistance on the rise for many bacteria.

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IACP Affiliate News

Help minimize the risks posed by hazardous drugs

Did you know that in the US, more than 270,000 pharmacists and more than 400,000 pharmacy technicians may be exposed to hazardous drugs?

USP's interactive eLearning course on General Chapter <800>Hazardous Drugs - Handling in Healthcare Settings will help you gain knowledge to reduce the risks that may be posed to you by handling hazardous drugs.

Use code: 800elearning418

May 21st - 22nd, 2018

Workshop Overview

USP will host an inaugural workshop on improving the quality and safety of compounding to enhance patient safety through standardization of commonly compounded medicines.

The workshop will convene a wide range of stakeholders to:

Explore current trends, initiatives and regulations for safe compounding
Discuss ongoing strategies to improve patient safety through standardization of commonly compounded medicines
Understand safe utilization of compounded preparation monographs (CPMs)
- Learn about USP's compounding monograph development prioritization and development process
- Collaborate in the development of a framework for analytical testing to establish reliable beyond-use dates for formulations based on robust stability studies
- Explore ways of accelerating the development of CPMs with the highest public health impact
Connect with peers and USP staff and identify ways to get involved.

You should attend if you:

are a healthcare provider who prescribes, prepares or administers compounded medicine to meet the tailored needs of patients
are an academician who conducts research and development for compounded formulations
source, manufacture or distribute API (active pharmaceutical ingredient), excipients, product or equipment for the compounding of medicine
represent a contract lab that tests and develops compounded formulations
are a drug manufacturer
participate in the regulation or accreditation of compounding facilities at the state or federal level

For more information click HERE.

USP Announces Comment Period for

Chapters <795> and <797>

USP General Chapters <795> Pharmaceutical Compounding - Nonsterile Preparations , and <797> Pharmaceutical Compounding - Sterile Preparations are in the active revision process. The purpose of this alert is to provide you details of upcoming opportunities where you can participate in the public comment process for the proposed revisions.

To provide a unified approach to quality compounding, USP intends to align the timing and content of General Chapters <795>, <797>, and <800>Hazardous Drugs-Handling in Healthcare Settings. Among other proposed content in the revisions, hazardous drug handling sections in <795> and <797> will reference General Chapter <800>.

General Chapter <800> was completed and published in February 2016, and the content of that chapter is not currently under revision.

Below are the timeline and associated web links for you to engage and provide input during the public comment periods for <795> and <797>. You will be able to provide written comments through the USP website from March 30, 2018 to July 31, 2018 for USP <795>, and from July 28, 2018 to November 30, 2018 for USP <797>.

Schedule & Links for Compounding Standards

Click the links for access where the respective information will be posted
	<795> * *Pharmaceutical Compounding -* *Nonsterile Preparations*	<797> * Pharmaceutical Compounding - *Sterile Preparations*
Pre-Posted on the USP Website for Public Comment**	March 30, 2018	July 28, 2018
Published in thePharmacopeial Forum	May 1, 2018	September 4, 2018
Open Microphone Session Registration will open	April 20, 2018 March 15, 2018	September 5, 2018 August 5, 2018
Public Comment Period will close	July 31, 2018	November 30, 2018
Intended Publication DateUSP - NF	June 1, 2019	June 1, 2019
Anticipated Official Date	December 1, 2019	December 1, 2019

* The current published versions of USP-NF General Chapters <795> and <797> are official until new chapters

become official.

** This pre-posting allows extra time, beyond the typical 90 day period, for stakeholders to review and provide

input.

USP Debuts New Resource - USP <800> HazRx™ Mobile App.

The <800> HazRx™ Mobile App is an innovative tool that combines information from three trusted data resources (NIOSH, RxNorm, General Chapter <800>) to help identify hazardous drugs at the point of practice and to inform the healthcare worker on what measures to take to help reduce their risk in accordance with established standards.

As we all move toward safer handling of hazardous drugs in the work place, USP encourages early adoption and implementation of USP General Chapter <800> to protect the public health in all healthcare settings.