2023-03158. Compounding Certain Ibuprofen Oral Suspension Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability

AGENCY:

Food and Drug Administration, Department of Health and Human Services (HHS).

ACTION:

Notice of availability.

SUMMARY:

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry entitled “Compounding Certain Ibuprofen Oral Suspension Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act.” This guidance describes FDA's regulatory and enforcement priorities regarding compounding certain ibuprofen oral suspension products by outsourcing facilities to provide to hospitals and health systems for administration within the hospital or health-system and State-licensed pharmacies (including those within hospitals and health systems), and applicable Federal facilities, to dispense to patients for use at home after receiving a valid, patient-specific prescription. This final guidance revises and replaces the guidance of the same name issued on January 25, 2023. Revisions were made to describe the Agency's regulatory and enforcement priorities regarding the compounding of certain ibuprofen oral suspension products by outsourcing facilities to provide to State-licensed pharmacies (including those within hospitals and health systems), and applicable Federal facilities, to dispense to patients for use at home after receiving a valid, patient-specific prescription.

DATES:

The announcement of the guidance is published in the Federal Register on February 15, 2023.

ADDRESSES:

You may submit either electronic or written comments on Agency guidances at any time as follows:

Electronic Submissions

Submit electronic comments in the following way:

• Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.

• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions

Submit written/paper submissions as follows:

• Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

Instructions: All submissions received must include the Docket No. FDA-2023-D-0169 for “Compounding Certain Ibuprofen Oral Suspension Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.

• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/​content/​pkg/​FR-2015-09-18/​pdf/​2015-23389.pdf.

Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.

You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).

Submit written requests for single copies of the guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT:

Ian Reynolds, Office of Compounding Quality and Compliance, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 240-402-7079.

SUPPLEMENTARY INFORMATION:

I. Background

We are announcing the availability of a guidance for industry entitled “Compounding Certain Ibuprofen Oral Suspension Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act.” This guidance is being implemented without prior public comment because FDA has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 371(h)(1)(C)) and 21 CFR 10.115(g)(2)). This guidance is being implemented immediately to bolster consumer access to ibuprofen oral suspension products at State-licensed pharmacies and applicable Federal facilities during the winter months when respiratory infections are likely to be elevated, but it remains subject to comment in accordance with the Agency's good guidance practices.

The United States is currently experiencing a significant number of infections involving three viruses: Coronavirus Disease 2019 (COVID-19), respiratory syncytial virus (RSV), and influenza. Each of these viruses may produce fever in young children. FDA has received reports related to increased demand for pediatric fever-reducing medications, including ibuprofen oral suspension products. Further, FDA has received a number of reports related to State-licensed pharmacies experiencing challenges with obtaining these medications for use at home for fever and pain treatment of pediatric patients as well as for adults who are unable to swallow solid oral dosage forms.

As explained in the Federal Register of January 25, 2023, this guidance describes the Agency's regulatory and enforcement priorities regarding the compounding of certain ibuprofen oral suspension products by outsourcing facilities to provide to hospitals and health systems for administration within the hospital or health system (see 88 FR 4828). FDA has revised this guidance to also describe the Agency's regulatory and enforcement priorities regarding the compounding of certain ibuprofen oral suspension products by outsourcing facilities to provide to State-licensed pharmacies (including those within hospitals and health systems), and applicable Federal facilities, to dispense to patients for use at home after receiving a valid, patient-specific prescription. FDA is continually assessing the needs and circumstances related to the temporary policy set forth in this guidance, and as relevant needs and circumstances evolve, FDA intends to update, modify, or withdraw this policy as appropriate.

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on “Compounding Certain Ibuprofen Oral Suspension Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not required for this guidance. The previously approved collections of information are subject to review by OMB under the PRA. The collection of information for current good manufacturing practice requirements has been approved under OMB control number 0910-0139. The collections of information for adverse event reporting and human drug compounding under sections 503A and 503B (21 U.S.C. 353a and 353b) of the FD&C Act have been approved under OMB control number 0910-0800. The collections of information for adverse event and product experience reporting under the MedWatch System has been approved under OMB control number 0910-0291.

III. Electronic Access

Persons with access to the internet may obtain the guidance at https://www.fda.gov/​drugs/​guidance-compliance-regulatory-information/​guidances-drugs, https://www.fda.gov/​regulatory-information/​search-fda-guidance-documents, or https://www.regulations.gov.

Dated: February 9, 2023.

Lauren K. Roth,

Associate Commissioner for Policy.