Document headings vary by document type but may contain the following:
See the Document Drafting Handbook for more details.
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
DATES:
Submit written comments (including recommendations) on the collection of information by October 23, 2024.
ADDRESSES:
To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting “Currently under Review—Open for Public Comments” or by using the search function. The OMB control number for this information collection is 0910-0858. Also include the FDA docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
Human Drug Compounding, Repackaging, and Related Activities Regarding Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act
OMB Control Number 0910-0858—Extension
This information collection helps support implementation of sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 353a and 21 U.S.C. 353b), which govern compounding by pharmacies, outsourcing facilities, and other entities. Compounding is generally a practice in which a licensed pharmacist, a licensed physician, or, in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist, combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individual patient. Although compounded drugs can serve an important medical need for certain patients, they also present risks to patients. FDA's compounding program aims to protect patients from unsafe, ineffective, and poor-quality compounded drugs, while preserving access to lawfully marketed compounded drugs for patients who have a medical need for them. Respondents to the information collection are pharmacies, outsourcing facilities, and other entities.
To assist respondents in complying with statutory requirements, we have issued the following topic-specific guidance documents:
Table 1—Published Guidance Documents Regarding Sections 503A and 503B of the FD&C Act
| Title | Notice of availability publication date |
|---|---|
| Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies, Federal Facilities, and Certain Other Entities (Radiopharmaceutical Compounding and Repackaging Guidance) (available at https://www.fda.gov/media/102615/download ) | September 26, 2018 (83 FR 48633). |
| Compounding and Repackaging of Radiopharmaceuticals by Outsourcing Facilities (Radiopharmaceutical Compounding and Repackaging by Outsourcing Facilities Guidance) (available at https://www.fda.gov/media/102637/download ) | September 26, 2018 (83 FR 48630). |
| Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities (Repackaging Guidance) (available at https://www.fda.gov/media/90978/download ) | January 13, 2017 (82 FR 4343). |
| Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application (Biological Products Guidance) (available at https://www.fda.gov/media/90986/download ) | January 19, 2018 (83 FR 2787). |
Table 2—Estimated Annual Reporting Burden
Table 3—Estimated Annual Recordkeeping Burden
Table 4—Estimated Annual Third-Party Disclosure