FDA issues final rules for manufacture of PET radiopharmaceuticals
The ruling, which is slated to go into effect on Dec. 12, 2011, will dictate the facilities and controls that can be utilized for the production, holding, distribution or quality assurance of PET radiopharmaceuticals intended for IV administration into a patient for diagnostic purposes, said the agency.
In referencing its regulations regarding non-PET drugs, the agency noted that PET drugs as well as the production of these agents differ significantly in terms of cGMP regulations. The “unique nature” of PET radiopharmaceuticals had to be considered when coming to the final ruling, as these drugs were previously not considered a “regularity priority” for the agency.
The report noted several differences between PET cGMP requirements when compared to non-PET drugs, including:
- Differences concerning personnel;
- Aseptic processing;
- Quality control of components;
- Self-verification of production steps;
- Same-person oversight of production,
- Authorization of product release; and
- Labeling requirements.
As well as the aforementioned requirements, the agency also included standard guidelines for facilities and equipment, laboratory controls, finished drug product acceptance procedures, complaint processing and the maintenance of records in the final ruling.
The FDA said that upon implementation of the ruling, the safety, identity, strength, quality and purity of PET agents will be established, with the goal of protecting patients from adverse events brought on by PET drugs that have not met the requirements.
Small entities, (including pharmaceutical preparation manufacturers with 750 or fewer employees and for-profit hospitals, clinics, colleges and universities with $29 million or less in revenue) were noted by the agency as having the potential to run into the most difficulties in meeting the requirements.
“At most, a single PET drug producer may incur one-time and annual costs of approximately $57,900 and $32,400,” said the agency, as some of these small agencies may be forced to contract with an outside consultant in complying with the ruling.
Furthermore, the agency said, the “hospital and regional commercial producers will incur these higher per facility costs because these establishments are expected to have higher noncompliance rates with the written procedure and recordkeeping requirements. The total of the maximum one-time and annual costs per producer equates to significantly less than 1 percent of the $111 million average annual gross revenue per nonprofit hospital."