United States Nuclear Regulatory Commission - Protecting People and the Environment

U.S. Nuclear Regulatory Commission

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

HPPOS-282 PDR-9306160177

Title: 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

Page Last Reviewed/Updated Thursday, March 29, 2012