International Academy of Compounding Pharmacists (IACP) Urges Congress to Protect Patient Access to Compounded Medications

Washington, D.C. – January 30, 2018 – The International Academy of Compounding Pharmacists (IACP) testified today before the U.S. House of Representatives’ Energy & Commerce’s Health Subcommittee Hearing on pharmacy compounding, “Examining Implementation of the Compounding Quality Act.”

IACP Vice President Shawn Hodges, PharmD, served as a witness representing 503A compounding pharmacies at today’s Congressional hearing. Dr. Hodges’ written testimony submitted to the Congressional Health Subcommittee can be viewed in its entirety here.

Dr. Hodges’ oral testimony focused on areas that the Food & Drug Administration (FDA) and stakeholders can work together towards compounding policies that better balance patient safety with patient access to critical medications.

IACP is an association representing more than 4,000 pharmacists, technicians, students, and members of the compounding community who focus upon the specialty practice of pharmacy compounding. Pharmacy compounding is the long-established tradition in pharmacy practice that enables physicians to prescribe and patients to take medicines that are specially prepared by pharmacists to meet patients’ individual needs.

Every day, compounding pharmacists serve patients in a variety of areas including: autism, oncology, dermatology and pediatrics, in a variety of practice settings including hospice in-patient units, emergency rooms, surgical centers, physician clinics, and even Federal Facilities like the VA. Compounding pharmacists also have served patients such as pre-term infants who require parenteral nutrition (PN). PN provides intravenous lifesaving therapy for patients whose gastrointestinal (GI) tracts are not functioning or cannot be accessed, or where nutritional needs cannot be met with oral or enteral diets. These are just a few examples of how compounding pharmacists are working with physicians to provide life-saving medications for patients.

While encouraged by some of the intended policy changes announced in the “2018 Compounding Policy Priorities Plan” released by the FDA, IACP is hopeful that this hearing will result in improved dialogue between the FDA and stakeholders, and that future FDA compounding policies will better reflect the input the Agency has received from prescribers and pharmacists. Our written testimony for this hearing of the Health Subcommittee is focused on the following policy areas:

• Office-use compounding pursuant to state pharmacy laws and regulations;
• The draft sample MOU between FDA and states on interstate distributions;
• Appropriate inspection standards for compounding pharmacies;
• Compounding with dietary supplements;
• Policymaking through Guidance for Industry instead of rulemaking;
• The Pharmacy Compounding Advisory Committee (PCAC).

IACP appreciates the opportunity to testify in today’s Congressional hearing on the many issues surrounding FDA’s implementation and enforcement of the DQSA. We strongly support HR2871 as a much-needed clarification and strengthening of the DQSA, and again urge the Congress to pass the bill this year. IACP stands ready to work with Congress to establish laws and regulation that protect patient safety, including access to critical compounded medications. 

About IACP

The International Academy of Compounding Pharmacists (IACP) is an association representing more than 4,000 pharmacists, technicians, students, and members of the compounding community who focus upon the specialty practice of pharmacy compounding. Compounding pharmacists work directly with prescribers including physicians, nurse practitioners and veterinarians to create customized medication solutions for patients and animals whose healthcare needs cannot be met by manufactured medications. More than 150,000 patients and prescribers also belong to our organization via the grassroots advocacy group, Partnership for Personalized Prescriptions (P3). IACP’s mission of protecting, promoting and advancing personalized medication solutions is critical for patient healthcare. Visit www.iacprx.org to learn more and to find a compounding pharmacist.

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Energy & Commerce’s Subcommittee on Health to Hold Pharmacy Compounding Hearing THIS MORNING at 11 am Eastern Time

IACP Vice President Shawn Hodges, PharmD to Serve as Witness
for Pharmacy Compounding

The U.S. House of Representatives’ Committee on Energy & Commerce’s Subcommittee on Health will hold a hearing this morning, at 10:00 a.m. Central Time/11:00 a.m. Eastern Time in 2123 Rayburn House Office Building. The hearing is entitled, “Examining Implementation of the Compounding Quality Act.”

The International Academy of Compounding Pharmacists (IACP) has been invited to serve as a witness by the Subcommittee on Health chaired by U.S. Congressman Michael C. Burgess, MD (TX).

IACP Vice President Shawn Hodges, PharmD, will serve as a witness representing 503A compounding pharmacies. Please click here to view Shawn’s bio. On behalf of the IACP Board of Directors, we thank Shawn for his willingness and dedication to serve our profession at this hearing.

Watch Hearing Live Webcast

PLEASE NOTE: The hearing webcast will be made publicly available at
https://energycommerce.house.gov/hearings/examining-implementation-compounding-quality-act/

View Witness List and Background Materials

Please click here to view the complete witness list for this morning’s hearing.
IACP is working on your patients’ behalf to protect access to compounded medications! This hearing is a critical opportunity to present the value and necessity compounded medications bring to patients and the providers who serve them.

Please email IACP with questions or comments at iacpinfo@iacprx.org. We will make you aware of continuing developments.

Saving Patient Access to Life-Saving Compounded Medications is a Patient-Safety Issue!

Associate Attorney General Brand Announces End To Use of Civil Enforcement Authority to Enforce Agency Guidance Documents

On Thursday, January 25th, the Associate Attorney General issued a memorandum that prohibits the Department of Justice from using civil enforcement authority to “convert agency guidance documents into binding rules.” According to the Memorandum published on the Department of Justice website, Justice Department civil litigators are prohibited from using guidance documents – or noncompliance with guidance documents – to establish violations of law in affirmative civil enforcement actions. Further, in that same news release, DOJ Associate Attorney General Brand stated “Although guidance documents can be helpful in educating the public about already existing law, they do not have the binding force or effect of law and should not be used as a substitute for rulemaking.”

PLEASE NOTE: IACP currently is reviewing this information and determining what impact this has for current FDA Guidance for Industry (GFI) documents. IACP will send you additional updates as they become available.

Please see the Department of Justice’s press release below.

Department of Justice
Office of Public Affairs
FOR IMMEDIATE RELEASE
Thursday, January 25, 2018

Associate Attorney General Brand Announces End To Use of Civil Enforcement Authority to Enforce Agency Guidance Documents

Today, as a follow-up to a memo issued by Attorney General Jeff Sessions in November, the Office of the Associate Attorney General issued a new policy that prohibits the Department of Justice from using its civil enforcement authority to convert agency guidance documents into binding rules. Under the Department’s new policy, Department civil litigators are prohibited from using guidance documents-or noncompliance with guidance documents-to establish violations of law in affirmative civil enforcement actions.

On November 17, 2017, Attorney General Jeff Sessions issued a memo prohibiting the Department of Justice from issuing guidance documents that have the effect of adopting new regulatory requirements or amending the law binding on persons or entities outside the Executive Branch. The memo prevents the Department of Justice from evading required rulemaking processes by using guidance memos to create de facto regulations. In the past, the Department of Justice and other agencies had blurred the distinction between regulations and guidance documents.

“Although guidance documents can be helpful in educating the public about already existing law, they do not have the binding force or effect of law and should not be used as a substitute for rulemaking,” Associate Attorney General Rachel Brand said. “Consistent with our duty to uphold the rule of law with fair notice and due process, this policy helps restore the appropriate role of guidance documents and avoids rulemaking by enforcement.”

NOTE: The new policy can be found here.

Component(s):

Office of the Associate Attorney General
Press Release Number:
18 – 96

 

Energy & Commerce’s Subcommittee on Health to Hold Pharmacy Compounding Hearing on Tuesday, January 30, 2018

The U.S. House of Representatives’ Committee on Energy & Commerce’s Subcommittee on Health will hold a hearing on Tuesday, January 30, 2018, at 11:00 a.m. Eastern Time in 2123 Rayburn House Office Building. The hearing is entitled,“Examining Implementation of the Compounding Quality Act.”

The International Academy of Compounding Pharmacists (IACP) has been invited to serve as a witness by the Subcommittee on Health chaired by U.S. Congressman Michael C. Burgess, MD (TX).

IACP Vice President Shawn Hodges, PharmD, will serve as a witness representing 503A compounding pharmacies. Please click here to view Shawn’s bio. On behalf of the IACP Board of Directors, we thank Shawn for his willingness and dedication to serve our profession at this hearing.

Click here to read more, including how to access the hearing webcast.

View the complete hearing witness list here.

IACP Quoted on Drug Shortages in Pharmacy Today

International Academy of Compounding Pharmacists (IACP) Board Member Shawn Hodges is quoted in this APhA – American Pharmacists Association Pharmacy Today article on drug shortages.

“Currently, FDA and Congress disagree on the ability of compounding pharmacies to provide compounded medications during the ongoing drug shortage situation, said Shawn Hodges, PharmD, International Academy of Compounding Pharmacists board member.

“The FDA actions in implementing the Drug Quality and Security Act (DQSA) contrary to Congressional intent have decreased patient access and further impeded the ability of compounding pharmacists to effectively compound medications for providers and health systems to be administered to patients.” The practice is often termed “office-use.” Hodges explained that before FDA implemented the DQSA, many states authorized the practice of traditional state-licensed pharmacists to provide compounded medications to health care providers and facilities for administration to patients.”

 Please click here to read the full article.

FDA Announces Withdrawal of Draft Guidance for Industry #230 Regarding Animal Drug Compounding

The U.S. Food and Drug Administration is withdrawing draft Guidance for Industry (GFI) #230, “Compounding Animal Drugs from Bulk Drug Substances.”

According to FDA’s announcement, it’s withdrawing the draft Guidance for Industry (GFI) “in order to clarify the agency does not plan to finalize the current draft; but, instead intends to issue a new draft for public comment next year.”

IACP Statement 

From IACP Executive Vice President Cynthia Blankenship: Due to the overwhelming comments and concerns expressed by the International Academy of Compounding Pharmacists (IACP), other organizations and YOU, FDA has announced it is withdrawing the animal compounding GFI. Please see the comments IACP submitted to FDA on November 16, 2015.

IACP expressed these concerns to FDA in face-to-face meetings as well as via submitted comments. We hope that FDA will clearly state that the Drug Quality & Security Act (DQSA) does not apply to animal compounding, and help remedy the mass confusion the GFI and other FDA announcements and statements, intermingling human and animal compounding have caused for the States, providers, patients, and pharmacists.

We hope to work with FDA on both human and animal compounding activities to make certain that DQSA is implemented pursuant to Congressional intent, and patient access is preserved for these vital, life-saving medications. Patient access to compounded medications is a patient safety issue.

Please email us with questions at iacpinfo@iacprx.org.

Patient access to compounded medications is a patient safety issue.

IACP Tells Drug Topics – “We could help with sodium bicarbonate shortage if we were allowed to compound for office use!”

The International Academy of Compounding Pharmacists (IACP)’s President Baylor Rice, RPh, FIACP, explains to Drug Topics that compounding pharmacists could help in the current sodium bicarbonate shortage if they were allowed to provide office-use compounding.

Click here to read Drug Topics’ “Could Compounding Pharmacists Solve the Sodium Bicarbonate Shortage?”

“Patient harm, as a result from limited-to-no-access of a drug shortage product, can be remedied if FDA understands that access to compounded preparations goes much farther than the brick and mortar of a pharmacy,” said Rice. “Prescribers, nurses, and other health-care entities require that compounded preparations need to be available for immediate-use in emergency situations. The only way to meet this requirement is for the practitioner to house a small supply of the product in the practitioner’s office.”

Inside Health Policy: As FDA Ignores Pressure from Appropriators on DQSA, Lawmakers Push FDA to Withdraw Guidance on Compounding, Issue Rule Allowing Practice.

Published in today’s (May 24, 2017) Inside Health Policy: “As FDA Ignores Pressure from Appropriators on DQSA, Lawmakers Push FDA to Withdraw Guidance on Compounding, Issue Rule Allowing Practice.”

Congressman Buddy Carter and the International Academy of Compounding Pharmacists (IACP) are both quoted in this piece, questioning why the Food & Drug Administration (FDA) continues to ignore the Drug Quality & Security Act’s (DQSA) Congressional intent on office-use compounding.

From the article – “Reps. Buddy Carter (R-GA) and Chris Stewart (R-UT) and 63 other lawmakers argued in a bipartisan letter to FDA Commissioner Scott Gottlieb Tuesday (May 23) that FDA’s compounding policy goes against congressional intent. At issue is a final guidance released in December, “Prescription Requirement under 503A of the Food, Drug and Cosmetic Act,” that requires that compounders only compound a drug for an individual patient with a prescription, or when a history of prescriptions and an established relationship allows a pharmacist to anticipate receiving a prescription.”

Click here to read the entire article.

Congress Acts to Preserve Patient Access to Compounded Medications by Including Compounding Language in Federal Funding Law

In a considerable win for patients who need compounded medications, the International Academy of Compounding Pharmacists (IACP), working with the DQSA Coalition, is very pleased to announce that the President has signed the Congressional Omnibus bill into law, H.R. 244, which provides funding through September 30, 2017, and includes language that addresses the Memorandum of Understanding, office-use, and pharmacy inspections.

Champions in Congress have acted to preserve access to patients that turn to compounding for lifesaving medications. This bipartisan legislation includes critical language which clarifies congressional intent on several compounding regulations implementing the Drug Quality and Security Act (DQSA) of 2013. The regulations addressed are among those on which Congress had asked FDA for additional clarity and expressed strong concern that FDA implementation actions were drastically decreasing patient access to vital compounded medications.

The language calls on FDA to do the following:

• Draft a new memorandum of understanding that does not include “dispensing” within the MOU. Congress expressed concern that the FDA draft MOU includes both “dispensing” and “distribution” of compounded medications.  Congress made clear in the language that FDA does not possess this authority and specifically stated, “Congress only allowed the FDA to regulate distribution” under the MOU and “Congress did not intend to include dispensing of compounded drugs over state lines within the scope of the MOU.”

• Release new guidance to allow 503A pharmacists to compound for “office-use” for prescribers, hospitals and other health systems. Congress expressed concern that patient access is decreasing to compounded medications, due to FDA’s implementation actions of prohibiting all office-use compounding even where “this practice is authorized in the vast majority of states and was intended to be allowable under DQSA.”

• Cease inspecting state-licensed 503A pharmacies under current Good Manufacturing Practices (cGMPs). Congress instructed FDA to inspect 503A pharmacies under USP standards or other applicably pharmacy inspection standards adopted by state law or regulation. Congress also stated that it “reminds the FDA that compounding pharmacies are not drug manufacturers, but rather, are state licensed and regulated health care providers that are inspected by state boards of pharmacy pursuant to state laws and regulations.”  Congress further stated, “compounding pharmacies are more appropriately inspected using USP standards or other pharmacy inspection standards adopted by state law or regulation in the state in which a pharmacy is licensed.” 

IACP would like to express our gratitude to the Representatives and Senators who worked tirelessly to preserve patient access to vital compounded medications, which can mean the different between life and death for the patients that depend upon these compounded medications. 

 

Drug Topics Interviews IACP on NECC Tragedy and the Future of Compounding

IACP’s Executive Vice President John Voliva, RPh, is extensively quoted in a Drug Topics article this week, NECC and the Future of Compounding Pharmacy.

“The FDA and Massachusetts Board of Pharmacy, according to Voliva and many other members of the media, “had clear authority to investigate and take action that would have stopped the operations at New England Compounding Center, and both had been informed of problems there. Neither did.”

“The NECC tragedy provided more evidence that an increase in the communication and coordination between the FDA and the State Boards of Pharmacy was vital,” said Voliva.

Read the entire article and more of Voliva’s comments here.