Compounding is Regulated, Mr. Miller.

Have you read the opinion piece by Henry I. Miller in Forbes? “Lax FDA Oversight Of ‘Compounded Drugs’ Is A Matter Of Life And Death.” Unfortunately what we have here is another example of uninformed and just plain inaccurate reporting. Mr. Miller states that pharmacy compounding is virtually unregulated, and “loopholes in the regulations that set the standards for a practice called ‘drug compounding’ have enabled dangerous products to injure and kill untold numbers of unsuspecting patients.” Mr. Miller seems to be woefully unaware of the regulatory role state boards of pharmacy have engaged in for years in pharmacy compounding as well as of U.S. Pharmacopeial (USP) rigorous standards that are in place. Mr. Miller also has completely discounted the existence of the Drug Quality & Security Act (DQSA) which regulates pharmacies, namely those engaging in inter-state commerce and making sterile medications which are often dispensed to physicians and hospitals.

IACP is setting the record straight with Mr. Miller. We urge our members to do the same. Leave Mr. Miller your take on his opinion piece in the article’s comments section. Let’s set the record straight about our profession! Read the entire article and leave your comments by clicking here.

FDA Announces Inspection Procedural Change and Releases Additional Guidance Documents

Inspections Procedure Change

Today, FDA posted a notice announcing a change in its procedure for inspections of certain human drug compounders, which will take effect on August 1, 2016. FDA has stated it’s making this change in response to stakeholder input. Click here to view FDA’s notice.

One of IACP’s primary 2016 Compounders on Capitol Hill Asks (click here to view) challenged FDA’s inspections of 503A compounding pharmacies using Current Good Manufacturing Standards (cGMPs) instead of under U.S. Pharmacopeial (USP) or other standards established by state pharmacy laws and regulations.

Specifically IACP has questioned why: (1) records of inspections (483s) based on cGMPs were published to the FDA’s website publicly, for all to see, even when FDA later determined the pharmacy was in compliance with section 503A and handed the pharmacy investigation back to the State Board of Pharmacy, and (2) the FDA would not always give pharmacies copies of the 483 when they were leaving the inspection. Essentially, pharmacies had to guess whether one would be issued and what would be in it.

Now according to FDA’s newly released notice, the inspector will have to make a preliminary determination that the pharmacy is or is not a 503A and alert them to that within the 483.

Although IACP is certainly encouraged by today’s notice, we are working to obtain clarification on what FDA will use to determine what constitutes a 503A pharmacy. It should be noted – we rarely see a Federal agency publish this type of notification where they outline a course correction in their procedures without some sort of influence. It is through the work of IACP, our members, the DQSA Coalition and our Congressional allies that result in the type of notification we saw the FDA publish today.

Thank you AGAIN to our Members for all of your efforts in making our CCH 2016 Asks heard by your congressional representatives. We also thank all of our current members and all of those who donate to the OneFund campaign – without your support, our work would not be possible! IACP will keep you apprised of any updates on this matter.

FDA Releases Additional Guidance

FDA released two draft guidance documents on July 8th regarding compounded drug products which are “essentially copies” of commercially available drugs under Section 503A and 503B. The guidance documents can be found at the below links.

Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act

Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act

IACP is reviewing these guidance documents and will provide a summary to the IACP membership.

Please email IACP at iacpinfo@iacprx.org with any questions. Thanks for your support!

IACP Names John Voliva Executive Vice President

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The International Academy of Compounding Pharmacists (IACP) has named John Voliva, RPh, as its new Executive Vice President. Voliva will assume IACP’s EVP role on Monday, April 4, 2016. The EVP search was managed by a six-person committee representing the interests of the IACP Board of Directors, the IACP Foundation Board, IACP members and industry suppliers.

“IACP’s Search Committee is extremely confident that we found the most qualified person to lead the organization forward. After a national search, John Voliva’s extensive experience made him the clear choice for the position,”said Gary McCrory, RPh, CCN, IACP President. “John brings a distinctive combination of compounding pharmacy ownership, legislative relations at both a federal and state level, and a strong pharmacist background. He is one of us; he truly understands the value compounding pharmacy brings to patients, and how compounding pharmacists are the best suited in providing customized medications.”

“I am looking forward to continuing my work with this important sector of the profession—the compounding pharmacist,” Voliva said. “The compounding pharmacist’s ability to individualize medications, ensuring the most appropriate dose and delivery system which improves compliance, adherence and overall patient health outcomes. The provision of personalized medication solutions is the epitome of a patient-centric approach to health care.”

After receiving his bachelor of science in pharmacy degree from the Purdue School of Pharmacy and Pharmaceutical Sciences in 1999, Voliva became the owner/pharmacist of Hook’s Apothecary, Indiana’s first compounding-only pharmacy. For the past several years, he has worked for PCCA, a licensed bulk pharmaceutical repackager, as part of PCCA’s Public Affairs team. He is a long-time member of the International Academy of Compounding Pharmacists, National Community Pharmacists Association, American Pharmacists Association and Indiana Pharmacists Association. For the past two years, he has served on the DQSA Coalition which IACP established to ensure that the Drug Quality & Security Act legislation enacted in 2013 is being implemented as Congress fully intended.

Save-the-Date: IACP Member Town Hall on April 20th

Meet your new EVP John Voliva! Please join us for an IACP Member Town Hall on Wednesday, April 20th at 3:00 pm ET – 2:00 pm CT – 1:00 pm MT – 12:00 pm PT.

Call-information has been sent to all members. Please email iacpinfo@iacprx.org if you did not receive.

Congressman Buddy Carter Asks Dept of Health & Human Services About Office-Use Compounding

DQSA Coalition Milestone Report!

This morning in a House Education & Workforce Committee, Full Committee Hearing, “Examining the Policies and Priorities of the U.S. Department of Health and Human Services,” Congressman Buddy Carter (R-GA) questioned the Secretary of the U.S. Department of Health and Services Sylvia Mathews Burwell regarding office-use compounding.

Congressman Carter expressed concern that office-use provisions in the Drug Quality & Security Act (DQSA) are not being interpreted per congressional intent by the U.S. Food & Drug Administration (FDA). Secretary Burwell replied that office-use should be allowed per her understanding, and that she was prepared to work with Congress on this issue.

See the webcast archive link and the transcript below. Thank you Congressman Carter for placing this vital issue on the record!

Please click here to view the Archived Webcast from this morning’s session. Congressman Carter appears at the 2.00 portion of the webcast.

Transcript

Rep. Carter (R-GA-1): As a pharmacist I wanted to ask you about compounding for office-use. I am concerned about the FDA interpreting for legislative intent. The FDA continues to prevent medications to be compounded for office use. Many states have already allowed for this to take place. He pointed out that office use prevents patients from having to go to the doctor, get a prescription, then go to the pharmacists, and allows for doctors to dispense necessary medications to patients without the additional steps.

Sec. Burwell: We don’t have any guidance out preventing that, maybe my team can follow up with your staff. Right now compounding should be occurring and there should not be a problem with any rules.

Rep. Carter: The problem is that you are requiring each patient to have a prescription.

Sec. Burwell: It is my understanding that should be able to be allowed, so I look forward to working with you on that.

Rep. Carter pointed out that they are looking for a guidance on this topic, and the Secretary said they welcomed Congress’s input on any guidance.

IACP and the DQSA Coalition will continue to keep our Members apprised of updates as they are available. Please email questions to iacpinfo@iacprx.org

IACP Submits General Chapter 797 Comments

The International Academy of Compounding Pharmacists (IACP) has submitted formal comments to the United States Pharmacopeial Convention (USP) regarding General Chapter <797>. These comments are based upon IACP member input as well as the input of the IACP Legislative Committee and Board of Directors. Thank you to all members who provided feedback.

IACP General Chapter <797> Comments

Please click here to view IACP’s comments.

IACP Statement

IACP supports practices and quality standards for preparing compounded sterile human and animal drugs. However, IACP has strong concerns with several of the proposed revisions that would place an undue burden upon pharmacists and result in decreasing time spent with patients as well as patient access to vital compounded medications. At a time when patients are already facing decreased access to compounded medications due to skyrocketing drug shortages and new burdensome regulations, the Revised Chapter <797> will result in further decreasing patient access to these vital compounded medications. The burden that these revisions place on pharmacists will result in many pharmacists foregoing sterile compounding altogether resulting in further reducing patient access to medications. The sections within the Revised Chapter <797> that will burden pharmacists the most and have the greatest impact on decreasing patient access are the sections related to air quality monitoring, establishing beyond-use dates, and in-use times are of greatest concern.

IACP shares the concerns of many other organizations that the current revisions provide very few citations in support of the specific proposed requirements.  As the burden that is being placed on pharmacists is so high by these revisions as to lead to drastically reducing patient access to medications, IACP strongly encourages that any revisions proposed be based on data, studies, and specific information.

Therefore, while IACP appreciates USP’s work on this issue, IACP has strong concerns as to the unintended consequences of the proposed revisions on patient access to medications. IACP urges USP to consider patient access to compounded medications and revise the proposed revisions as detailed in our comments.

PLEASE NOTE: USP Extended the Comment Period to TODAY, Monday, February 1, 2016

If you have any questions, please email iacpinfo@iacprx.org.

USP Approves Chapter 800

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On Friday, November 20, 2015, the United States Pharmacopeial Convention (USP) announced that their Compounding Expert Committee has formally approved new General Chapter, <800>Hazardous Drugs—Handling in Healthcare Settings. The purpose of this General Chapter is to provide standards to protect personnel, patients and the environment when handling hazardous drugs (HDs). The chapter applies to all healthcare personnel and all entities which handle HDs. Building on existing standards and guidelines, General Chapter <800> provides a comprehensive approach for handling HDs in healthcare settings with the ultimate goal of preventing and/or limiting potential exposures to HDs.

The revised General Chapter <800> will be published on February 1, 2016 in the First Supplement to USP 39–NF 34. Additionally, the Expert Committee approved a delayed official implementation date of July 1, 2018 to allow entities more than two years to implement the chapter.

“The International Academy of Compounding Pharmacists (IACP) had requested many changes in the original published General Chapter earlier this year and we are very pleased to see that the Expert Committee took our concerns seriously.  Although the final chapter represents a significant improvement, there are still challenges that remain as pharmacies and health care professionals adapt to the new requirements,” says IACP Executive Vice President David Miller.  “We are especially glad that USP recognized the potential financial ramifications and the changes that compounding pharmacy practices will need to implement and provided two years for preparation.”

To see the official announcement, please click here. 

IACP Submits Comments to FDA on the Draft Guidance for Compounding Animal Drugs from Bulk Drugs

This week, the International Academy of Compounding Pharmacists (IACP) submitted formal comments to the Food & Drug Administration (FDA) regarding the Draft Guidance for Compounding Animal Drugs from Bulk Substances (GFI #230).

IACP’s Comments to FDA

Please click here to view the entire comments submitted to FDA regarding the GFI #230. To date, there have been 24 sets of comments sent to the FDA.

Why is GFI 230 a problem for compounders? “As proposed, the FDA’s Center for Veterinary Medicine (CVM) is attempting to circumvent the legislative process and, instead, create an entirely new approach to compounding,” says IACP Executive Vice President David Miller. “It’s not just that which concerns our membership and our Board, it’s that if left unopposed, these new policies could set a precedent to justify the FDA’s further efforts to regulate human compounding.”

For example, the GFI does away entirely with office-use for veterinarians and instead requires a patient-specific prescription for each and every compound. It applies language in federal human compounding statute to veterinary compounding without authorization from Congress and even gives human compounding registered 503B outsourcing facilities the ability to prepare veterinary compounds without authorization from Congress. Congress specifically provided for 503B outsourcing facilities to prepare sterile compounds for human use. FDA attempts to interfere with the traditional role of the states in defining what constitutes a valid prescription by requiring a series of specific statements on a ‘script before the pharmacist would be able to prepare and dispense the medication, potentially delaying prompt therapy for an animal in need.

“Additionally, for the first time ever, a health care practitioner – either a veterinarian or a pharmacist – would be required to report any and all adverse events to the FDA’s reporting system. Traditionally, doctors, pharmacists, nurses, and vets have participated in the voluntary MedWatch adverse event reporting program. If this goes into effect, how long before pharmacists will be required to report adverse events in compounded prescriptions for humans or, possibly, for any prescription they dispense?” explains Miller.

Thank You for Taking Action!

A big thank you to the more than 300 members who sent in their action alerts to your congressional representatives asking them to sign a letter to FDA to withdraw its Guidance for Industry #230: Compounding Animal Drugs from Bulk Substances. Your participation resulted in generating 20 congressional co-signers on the effort led by Congressmen Matt Salmon (R-AZ) and Kurt Schrader (D-OR).

The letter points out that the agency does not have statutory authority to interfere with the state-regulated practice of veterinary medicine. More importantly, the Congressmen point out that as written, the guidance attempts to create new regulatory authority without legislation to support that effort.

Please click here to view the final letter featuring 20 co-signers.

Take Action! Stop FDA’s Misguided Veterinary Compounding Guidance

At its September meeting, the International Academy of Compounding Pharmacists (IACP) Board of Directors unanimously voted to support a bipartisan Congressional letter, http://tinyurl.com/ptjdcw7, demanding that the Food & Drug Administration (FDA) withdraw its Guidance for Industry (GFI) #230: Compounding Animal Drugs from Bulk Substances. Led by Congressmen Matt Salmon (R-AZ) and Kurt Schrader (D-OR), the letter points out that the agency does not have statutory authority to interfere with the state-regulated practice of veterinary medicine. More importantly, the Congressmen point out that as written, the guidance attempts to create new regulatory authority without legislation to support that effort.

Why is GFI 230 a problem for compounders? “As proposed, the FDA’s Center for Veterinary Medicine (CVM) is attempting to circumvent the legislative process and, instead, create an entirely new approach to compounding,” says IACP Executive Vice President/CEO David G. Miller, RPh.  “It’s not just that which concerns our membership and our Board, it’s that if left unopposed, these new policies could set a precedent to justify the FDA’s further efforts to regulate human compounding.”

For example, the GFI does away entirely with office-use for veterinarians and instead requires a patient-specific prescription for each and every compound. It applies language in federal human compounding statute to veterinary compounding without authorization from Congress and even gives human compounding registered 503B outsourcing facilities the ability to prepare veterinary compounds without authorization from Congress. Congress specifically provided for 503B outsourcing facilities to prepare sterile compounds for human use. FDA attempts to interfere with the traditional role of the states in defining what constitutes a valid prescription by requiring a series of specific statements on a ‘script before the pharmacist would be able to prepare and dispense the medication, potentially delaying prompt therapy for an animal in need.

“Additionally, for the first time ever, a health care practitioner – either a veterinarian or a pharmacist – would be required to report any and all adverse events to the FDA’s reporting system. Traditionally, doctors, pharmacists, nurses, and vets have participated in the voluntary MedWatch adverse event reporting program. If this goes into effect, how long before pharmacists will be required to report adverse events in compounded prescriptions for humans or, possibly, for any prescription they dispense?” explains Miller.

What can you do to help with this important fight? Contact your Congressman’s office today and ask them to support the Salmon/Schrader letter requesting that FDA withdraw GFI #230. You can direct your Congressman’s staff to reach out to contact Greg Soften (greg.safsten@mail.house.gov) in Rep. Salmon’s office, or Chris Huckleberry (huck@mail.house.gov) in Rep. Schrader’s with questions and to sign onto the letter.

Watch for additional information and outreach from IACP on this important initiative in your e-mail and in our future publications.

IACP Podcast #15: Jay McEniry & David Miller Discuss Tricare

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IACP has developed an exciting Podcast series, bringing listeners the latest news, stories and discussions on pharmacy compounding. We’re featuring guests from throughout the industry, discussing issues that hit home for pharmacy compounders, prescribers, and the patients they serve.

Stay Tuned: New episodes of the IACPodcast come out each Wednesday at noon CST. Visit IACP’s Podcast/Publications webpage here.

IACP Podcast #15: Jay McEniry & David Miller Discuss Tricare

Please click here for a Podcast interview with special guests, David G. Miller, RPh, IACP Executive Vice President/CEO, and Jay McEniry, Executive Director, Patients and Physicians for Rx Access (SaveRxAccess.org). The topic is Tricare, and the current issues facing compounding pharmacists, and most importantly, the patients they serve.

Have an idea for a topic? Want to give us a suggestion? Maybe you have a question? Give us a call at the IACPublication line: 713-730-9043.

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