FDA Issues Draft Guidances on Compounding and Repackaging Radiopharmaceuticals

On December 28th, the FDA issued two draft guidances that describe FDA’s proposed policies regarding the compounding and repackaging of radiopharmaceuticals for human use by state-licensed nuclear pharmacies or federal facilities, and outsourcing facilities. According to FDA, “the policies proposed in the draft guidances attempt to strike an important balance between patient access to radiopharmaceuticals compounded or repackaged by state-licensed nuclear pharmacies, federal facilities, and outsourcing facilities, and the risks that such unapproved drugs present to patients.”

The first draft guidance, “Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies,” explains that, under current law, radiopharmaceuticals compounded or repackaged by state-licensed nuclear pharmacies and federal facilities are subject to all applicable provision of the FD&C Act related to the production of drugs. However, FDA recognizes that state-licensed pharmacies and federal facilities sometimes compound or repackage radiopharmaceuticals for patients who need them without obtaining FDA approval or meeting certain other requirements.

The second draft guidance, “Compounding and Repackaging of Radiopharmaceuticals by Outsourcing Facilities,” highlights that section 503B of the Federal Food, Drug, and Cosmetic Act applies to the compounding of radiopharmaceuticals, but not to radiopharmaceuticals that are repackaged, by outsourcing facilities. It proposes how FDA would apply the conditions of section 503B to radiopharmaceuticals compounded by outsourcing facilities. This guidance also specifies the conditions under which FDA does not intend to take action for violations of provisions of the FD&C Act regarding new drug approval requirements and labeling with adequate directions for use against an outsourcing facility that repackages radiopharmaceuticals.

The comment period for each of the draft guidances closes in 60 days. To submit your own comments, visit regulations.gov.

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FDA Releases SBIA Summary of eCTD Requirements

The U.S. Food and Drug Administration recently released a summary of the movement to require certain regulatory submissions to conform to the electronic Common Technical Document (eCTD) format.

The eCTD has been the standard format for submitting applications, amendments, supplements, and reports to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) since 2008.

View FDA’s summary »

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NRC Licensing Guidance for Eckert and Ziegler Ge-68/Ga-68 Generator

On September 28, 2016, the U.S. Nuclear Regulatory Commission published Licensing Guidance for Eckert and Ziegler GalliaPharm Germanium-68/Gallium-68 Pharmacy Grade Generator. All sections of this guidance apply to both medical licensee and commercial nuclear pharmacy licensee use of this generator unless otherwise specified. This guidance does not apply to licensees or applicants that will receive unit or bulk doses of Gallium-68 (Ga-68) radiopharmaceuticals rather than use the Eckert and Ziegler GalliaPharmTM generator themselves. These licensees and applicants will be regulated under Title 10 Code of Federal Regulations (10 CFR) 35.200 and, as such, authorized users (AU) must meet the requirements in 10 CFR 35.290.*

In July, NRC a memo authorizing regions to issue an exemption from decommissioning funding plan requirements (DFP) in 10 CFR 30.35(a)(1) for the possession and use of Germanium-68/Gallium-68 generators, when certain conditions are met.

*The Coalition is aware that this draft guidance applies only to Eckert and Ziegler generators and is working with the NRC to ensure that future guidance includes other generators.

Access the licensing guidance here »

 

 

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Sponsored Session from SNMMI Annual Meeting:PET Drug Manufacturing: Living in an FDA-Regulated World

The Coalition for PET Drugs recently sponsored a session focused on FDA topics relevant to PET drug manufacturers. The session was held at the 2016 annual meeting of the Society of Nuclear Medicine and Molecular Imaging (SNMMI) in San Diego. For the second year in a row, the session was co-sponsored with the Radiopharmaceutical Sciences Council (RPSC) of the SNMMI. This is an important collaboration, which demonstrates the alignment of the Coalition’s mission with that of the RPSC.

The session drew more than 100 attendees, representing academic PET drug manufacturers, commercial PET drug manufacturers, FDA representatives, and others.

In case you missed the session, the presentations are available here:

We hope the session was helpful for the PET community and we welcome your feedback. If you have any comments or questions related to the presentations or the sessions, please contact the Coalition at the link above or leave a comment below.

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Coalition Comments on PET GMP Recordkeeping Burden

On February 29, 2016, the Coalition submitted comments to the FDA on the burdens associated with the PET drug Good Manufacturing Practice (GMP) regulations at 21 CFR part 212. As previously reported, the FDA issued a Federal Notice on December 29, 2015. FDA included in their notice estimates of the recordkeeping and third-party disclosure burdens that are required to comply with the PET GMPs. The notice also describes some of the methodology that the FDA used to develop these estimates. The notice is in response to the Paperwork Reduction Act of 1995, which requires the FDA to estimate the recordkeeping burden required to comply with the PET GMPs.

The Coalition submitted comments on three areas of importance:

  1. Whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility
  2. The accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used
  3. Ways to enhance the quality, utility, and clarity of the information to be collected

View the Coalition comment letter

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Public Comments for PET GMP Recordkeeping Burden

The Coalition would like to make PET drug manufacturers aware of an announcement from the FDA that appeared in the December 29, 2015, issue of the Federal Register. The notice announces the opportunity for public comment on the annual recordkeeping and third-party disclosure burdens associated with the PET drug Good Manufacturing Practice (GMP) regulations at 21 CFR part 212. The notice is in response to the Paperwork Reduction Act of 1995, which requires the FDA to estimate the recordkeeping burden required to comply with the PET GMPs.

The notice contains the FDA’s estimates of the recordkeeping and third-party disclosure burdens that are required to comply with the PET GMPs. In addition, the notice describes some of the methodology that the FDA used to develop these estimates. Through the notice, the FDA invites comments on the following specific topics:

  1. Whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility;
  2. the accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
  3. ways to enhance the quality, utility, and clarity of the information to be collected; and
  4. ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

The comment period is open until February 29, 2016. The Coalition is considering options in response to this notice and will update this website as appropriate. Individuals, PET drug manufacturers, and any other stakeholder may submit comments. The notice is available at this URL: https://www.federalregister.gov/articles/2015/12/29/2015-32685/agency-information-collection-activities-proposed-collection-comment-request-current-good

Questions? Please leave a comment below.

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USP Seeking Comments on General Chapter Revisions. Deadline approaching!

The US Pharmacopeia (USP) is currently in the process of revising several general chapters that are important to the nuclear medicine community. The USP sets public standards that serve patients, academia, industry, regulators, healthcare professionals, and other stakeholders. As a long-standing part of the revision process, the USP seeks public comments on revisions before adopting final resolutions. Comments from the public play an important role in the USP standards setting process!

Chapter <821> Radioactivity describes requirements for instrumentation used in radioactivity measurements. The Expert Committee responsible for this chapter has revised <821> to update, clarify, and simplify the chapter. In addition, the Committee has created a new informational chapter <1821> to complement <821>. Once finalized, <821> will serve as an enforceable chapter with requirements for instruments used in radioactivity measurements and <1821> will serve as a source of educational information relevant to radioactivity measurements.

Simultaneously with changes to chapters <821> and <1821>, the USP is also introducing a new informational chapter <1823>, which is a source of educational information relevant to PET drugs. These chapters are available on the USP Key Issues page. In addition to the Key Issues page, the USP Quality Matters blog contains more information about these revisions. See: http://qualitymatters.usp.org/updating-quality-standards-nuclear-medicine-and-radioactive-materials.

Stakeholders are encouraged to participate in the standard setting process by commenting on these revisions. Stakeholders include radiopharmaceutical manufacturers and other entities that make radioactivity measurements according to USP standards. The USP is accepting public comments on these revisions until November 30, 2015.

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