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HPPOS-282 PDR-9306160177

Technical Assistance Request, MPI Pharmacy Services, Inc., License Amendment Regarding Authorized Users

See the memorandum from J. E. Glenn to R. R. Bellamy dated January 25, 1993. This memo responds to a technical assistance request, dated November 5, 1992, to review an amendment request by MPI Pharmacy Services, Inc. The amendment request would permit any authorized user on a MPI Pharmacy Services, Inc., license to be an authorized user at the Livingston, New Jersey, nuclear pharmacy (License No. 29-28341-02MD).

The licensee indicates a copy of the NRC or Agreement State license specifically listing the authorized user will be kept at the Livingston pharmacy for 3 years or until the individuals are specifically listed on the Livingston license. The licensee’s request to permit any authorized user on an MPI Agreement State license to be an authorized user on the Livingston license cannot be approved at this time. Reciprocal recognition of Agreement State authorizations may be appropriate at a later date, but currently drafted regulations may change the training and experience requirements for NRC licensees in the near future.

While the remaining part of the licensee’s request, permitting any authorized user on an NRC MPI license to be an authorized user on the Livingston license, could be approved, it is recommended that the licensee take the following alternative approach. The licensee should consider selecting one of their NRC licenses as the document that lists all authorized users. The other NRC licenses could then be amended to authorize use of an authorized user on the list. This system has been used successfully by other commercial nuclear pharmacies. It reduces NRC’s review of the proposed authorized user’s training and experience to a single review. It also minimizes MPI’s amendment application fees, and review time while it maximizes MPI’s flexibility in assigning and reassigning authorized users to specific nuclear pharmacies. If the licensee does not want to amend all the other licenses at one time, individual licenses can be amended as specific changes or renewals are needed. This system can also be used later to institute generic changes that may be applicable to all licenses.

Regulatory references: 10 CFR 30, 10 CFR 35, License Conditions

Subject codes: 1.3, 12.2

Applicability: Byproduct Material