Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Insanitary Conditions at Compounding Facilities.” Drug products compounded under insanitary conditions could become contaminated and cause serious adverse events, including death, in patients. FDA is issuing this guidance to help compounding facilities and State regulatory agencies understand some examples of what FDA considers to be insanitary conditions that could cause a drug to become contaminated or rendered injurious to health. These examples are intended to help compounding facilities take action to prevent the occurrence of these and other insanitary conditions, as well as to implement appropriate corrective actions when such conditions already exist.
The announcement of the guidance is published in the Federal Register on November 9, 2020.
You may submit either electronic or written comments on Agency guidances on any guidance at any time as follows:
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 Start Printed Page 71349as 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”).
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-2016-D-2268 for “Insanitary Conditions at Compounding Facilities.” 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.
- 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.
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 final guidance document.
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FOR FURTHER INFORMATION CONTACT:
Jinhee Lee, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 5225, Silver Spring, MD 20993, 301-796-6770.
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Start Supplemental Information
FDA is announcing the availability of a guidance for industry entitled “Insanitary Conditions at Compounding Facilities.” 
Under section 501(a)(2)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 351(a)(2)(A)), a drug is adulterated if it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth or rendered injurious to health. Drug products compounded under insanitary conditions could become contaminated and cause serious adverse events, including death, in patients. Although sections 503A and 503B of the FD&C Act (21 U.S.C. 353a and 353b) provide exemptions for compounded drugs from specified provisions of the FD&C Act if certain conditions are met, neither section provides an exemption from section 501(a)(2)(A) of the FD&C Act. Any drug that is prepared, packed, or held under insanitary conditions is deemed to be adulterated under the FD&C Act, including drugs produced by a compounding facility.
Since the 2012 fungal meningitis outbreak associated with injectable drug products that a pharmacy compounded and shipped to patients and healthcare providers across the country, the Agency has identified insanitary conditions at many of the compounding facilities that it has inspected, and numerous compounders have voluntarily recalled drug products intended to be sterile and also temporarily or permanently ceased sterile operations because of these findings. Generally, State licensed pharmacies do not register with FDA unless they are outsourcing facilities. As a result, the Agency is often not aware of these pharmacies, their conditions and practices, and potential problems with the quality of their drug products. Although FDA does conduct some surveillance inspections, FDA does not inspect the vast majority of State licensed pharmacies in the United States unless, for example, FDA receives a complaint, such as a report of a serious adverse event or product quality issue. FDA does, however, routinely inspect outsourcing facilities registered with FDA.
Regardless of whether a facility is routinely inspected by FDA, it is critical that both State licensed pharmacies and outsourcing facilities identify and remediate, as well as work to prevent, the occurrence of insanitary conditions within their facilities. Because insanitary conditions can result in drug contamination and patient injury, corrective action should be implemented expeditiously in order to prevent the recurrence of such conditions.
In the Federal Register of September 26, 2018 (83 FR 48631), FDA announced the availability of a revised draft guidance for industry entitled “Insanitary Conditions at Compounding Facilities.” The revised draft guidance provided examples of conditions that the Agency has observed at compounding facilities it has inspected and considers to be insanitary conditions. The revised draft guidance also described corrective actions that compounding facilities should take when they identify such conditions and the regulatory actions FDA may take in response to identified insanitary conditions.
FDA received comments on the revised draft guidance from various Start Printed Page 71350stakeholders (e.g., physicians, pharmacies, outsourcing facilities). Several comments were submitted concerning the implications of the policies described in the revised draft guidance for physicians who compound or repackage drug products or mix, dilute, or repackage FDA-licensed biological products in their offices. In response to these comments, FDA made changes, where appropriate, in the final guidance. The changes include adding a footnote to state that “processing of beta-lactams” does not refer to mixing, reconstituting, or other such acts that are performed in accordance with the directions contained in FDA-approved labeling; adding a footnote to reflect that the FDA does not generally object to rapid movement temporary blocking or disruption of first air in the ISO 5 area when necessary for the safe handling of radiopharmaceuticals to minimize radiation exposure, and revising the language in a footnote concerning the scope of physician compounding or repackaging activities to state that FDA generally does not intend to take action under section 501(a)(2)(A) of the FD&C Act against a physician who is compounding a drug product, repackaging an FDA-approved drug product, or who is mixing, diluting, or repackaging an FDA-licensed biological product, provided that it occurs in the physician's office for in-office administration to the physician's patients; and adding recommendations encouraging compounders to use risk evaluation strategies and risk management tools to develop appropriate controls necessary to prevent the occurrence of insanitary conditions at their facilities. In addition, editorial changes were made to the guidance for clarity.
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 “Insanitary Conditions at Compounding Facilities.” The examples described in the final guidance do not constitute an exhaustive list of conditions FDA considers to be insanitary conditions. 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
This guidance contains no collection 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.
However, this guidance refers to a previously approved FDA collection of information. This collection of information is subject to review by OMB under the PRA. The collections of information in 21 CFR part 7 pertaining to FDA's recall regulations have been approved under OMB control number 0910-0249.
III. Electronic Access
Persons with access to the internet may obtain the guidance at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.
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Dated: November 3, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-24807 Filed 11-6-20; 8:45 am]
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