In This Section
Has anyone attempted to add their regular Pharmacy Department to their existing Radioactive Materials License to include a sterile compounding area?
We are not aware of any nuclear medicine lab that has amended their Radioactive Materials License to include a sterile compounding area within the regular Pharmacy Department in order to comply with USP <797>. Certainly there are some facilities where the radiopharmacy lab is part of, and is operated by, the Pharmacy Department, but such examples are uncommon and were established for a variety of reasons other than solely because of USP <797>. Barriers to this idea may include, but are not limited to:
1. Radioactive materials regulations or license conditions that specify negative pressure in areas where radioactive materials are prepared and stored in contrast to positive pressure in areas where sterile drugs are prepared.
2. Possible requirement for additional radiation shielding in walls, etc.
3. Concern about radioactive contamination control.
4. If pharmacy facilities are used for radiopharmaceuticals, the pharmacy may be required to obtain additional State Board of Pharmacy licensing as a nuclear pharmacy, which then may require that all radiopharmaceuticals be prepared and dispensed by, or under the supervision of, a qualified nuclear pharmacist.
According to the “Radiopharmaceuticals as CSPs” section of <797>, radiopharmaceuticals shall be compounded in a negative airflow environment. The Nuclear Regulatory Commission (NRC) used to have a specific regulation (i.e., Title 10, Code of Federal Regulations, Part 35.205) which indicated that noble gases must be used and stored in a room with neg ative pressure. When Part 35 – “Medical Use of Byproduct Material” was changed in 2002, NRC dropped the specific regulation requiring negative pressure rooms. However, removing the negative pressure requirement from Part 35 does not mean that one does not have to comply with the ALARA (as low as reasonably achievable) principle as stipulated in Part 20 – “Standards for Protection against Radiation.” When the NRC finalized the revisions to Part 35, it stated in its “Summary of Public Comments and Responses to Comments” that “Part 35 licensees must comply with the occupational and public dose limits of Part 20”.
Although no longer required by NRC’s Part 35, negative pressure requirements may still exist in some state regulations and/or individual RAM license conditions. So check your state regulations and individual license.
The issue becomes that if there is a spill of a radioactive gas, aerosol, or even fine radioactive powders, a positive airflow room would spread the radioactive material outside of the room and could potentially contaminate outside areas and/or people. By having the room at negative pressure (or at least negative to the rooms around it), it reduces the potential for the spread of radioactive materials. It’s just good radiation safety practice to maintain negative airflow in areas using such readily dispersible radioactive materials.