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Pharmacist working in Nuc Pharmacy without UWHC Authorized User Status (17.2)

Pharmacist working in Nuc Pharmacy without UWHC Authorized User Status (17.2) - Policies, Clinical, UWHC Clinical, Department Specific, Pharmacy, Nuc Pharmacy

17.2





Effective Date:
Oct 2013

Chapter: Nuclear Pharmacy
Chapter

Policy #: 17.2
Original
Revision 10/16

Page 1
of 1

Title: Pharmacist working in Nuclear
Pharmacy without UWHC
Authorized User Status

I. PURPOSE: To outline the roles that may be delegated to pharmacists who provide
professional services in the Nuclear Pharmacy but who are not added to a Radioactive
Materials License and designated as an Authorized Nuclear Pharmacist.

II. PROCEDURE:
1. 10CFR Part 35 outlines Nuclear Regulatory Commission's oversight of the handling
and use of radiopharmaceuticals.
2. Section 35.11 states as follows:
A. A person may manufacture, produce, acquire, receive, possess, prepare, use, or
transfer byproduct material for medical use only in accordance with a specific
license issued by the Commission or an Agreement State, or as allowed in
paragraph (b) or (c) of this section.
B. A specific license is not needed for an individual who—
i. Receives, possesses, uses, or transfers byproduct material in accordance
with the regulations in this chapter under the supervision of an authorized
user as provided in § 35.27, unless prohibited by license condition; or
ii. Prepares unsealed byproduct material for medical use in accordance with the
regulations in this chapter under the supervision of an authorized nuclear
pharmacist or authorized user as provided in § 35.27, unless prohibited by
license condition.
3. Manipulation of unsealed radiopharmaceuticals (kit preparation, dose drawing) may
be done under the supervision of an authorized user physician or an authorized
nuclear pharmacist.
4. When the authorized nuclear pharmacist cannot supervise activities, activities in
items i and ii may be performed as long as an authorized user physician is able to
supervise.
A. Able to supervise means available through routine communication methods or
physically present on-site.
5. In all cases, activities performed in the nuclear pharmacy must be in accordance with
the specific license issued by Wisconsin (agreement state).
6. National and state oversight of pharmacy practice still apply (FDA, CFR, Wisconsin
Chapter 450, Wisconsin Phar Administrative Code) but NRC is the only entity to have
specific regulations that apply to the licensure requirements for radiopharmaceuticals.

III. COORDINATION:
1. AUTHORED BY: Scott Knishka, BCNP, R.Ph., Nuclear Pharmacy Supervisor
2. REVIEWED BY: Scott Perlman, M.D., Chief, Nuclear Medicine
3. REVIEWED BY: Dave Musa, R.Ph. Manager, Nuclear Pharmacy
4. REVIEWED BY: Steve Rough, R.Ph., Director of Pharmacy.


Approved By: ____________________________
Director of Pharmacy Services

Date: ________________