SNMMI submitted comments to the FDA on draft guidance “Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies.” The guidance 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.
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.”
SNMMI is broadly supportive of the direction of this guidance. As previously stated, SNMMI strongly recommends that FDA work with USP to develop a common understanding of activities defined and involved in the compounding of radiopharmaceuticals.
SNMMI has submitted comments on other general guidances related to compounding, but has long awaited specific guidance for radiopharmaceuticals. The society also recently provided recommendations to USP on sterile compounding of radiopharmaceuticals. SNMMI commends the FDA for the release of this guidance and encourages the FDA to support USP in the public standard setting process.
Read SNMMI’s full comment letter »
SNMMI has developed USP recommendations for compounded sterile radiopharmaceuticals. The recommendations aim to address certain common practices in the field of nuclear pharmacy that are not adequately defined by generally accepted practice standards. The society believes there is confusion in the field of nuclear pharmacy, which threatens the availability and the safe usage of radiopharmaceuticals in the U.S. The recommendations are a response to these challenges. The recommendations were developed by SNMMI’s Committee on Radiopharmaceuticals (COR) and approved by SNMMI’s Board of Directors. The COR worked with several professional organizations and trade associations in an attempt to rectify the situation. Our efforts to date have met with some success, but have still fallen short of realizing suitable standards that are generally accepted for common practices in nuclear pharmacy.
The COR believes that the USP, as the world’s leading organization for the development and maintenance of public standards, can play a critical role in the resolution of these challenges. The three recommendations from the white paper are:
- Recommendation 1. Establish an expert panel to delineate common practices that are defined as sterile compounding within the practice of nuclear pharmacy.
- Recommendation 2. Create a public standard for the preparation, compounding, and dispensing of sterile radiopharmaceuticals with the practice of nuclear pharmacy.
- Recommendation 3. Reinstate an expert committee dedicated to all standards for radiopharmaceuticals.
On September 29, SNMMI President Sally Schwarz sent the letter to the USP, where it is currently under consideration. Further details will be provided as they become available.
Access SNMMI’s full white paper »
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.
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 »
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 »
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.
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:
- Whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility
- The accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used
- Ways to enhance the quality, utility, and clarity of the information to be collected
View the Coalition comment letter