New Hampshire Code of Administrative Rules
He - Department of Health and Human Services
Subtitle He-P - Former Division of Public Health Services
Chapter He-P 4000 - NEW HAMPSHIRE RULES FOR THE CONTROL OF RADIATION
Part He-P 4032 - SPECIFIC LICENSES FOR MANUFACTURE OR TRANSFER OF CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL
Section He-P 4032.05 - Manufacture, Preparation, or Distribution of Radiopharmaceuticals Containing Byproduct Material for Medical Use
Universal Citation: NH Admin Rules He-P 4032.05
Current through Register No. 40, October 3, 2024
(a) An application for a specific license to manufacture, prepare, or distribute radiopharmaceuticals containing byproduct material for use by persons licensed pursuant to He-P 4035 shall be approved if:
(1) The applicant satisfies the requirements
specified in He-P 4030.09;
(2) The applicant submits evidence that the
applicant is at least one of the following:
a. Registered with the U.S. Food and Drug
Administration (FDA) as the owner or operator of a drug establishment that
engages in the manufacture, preparation, propagation, compounding, or
processing of a drug under 21 CFR 207.20(a);
b. Registered or licensed with a state or
federal agency as a drug manufacturer;
c. Licensed as a pharmacy by a state board of
pharmacy;
d. Operating as a
pharmacy within a federal medical institution; or
e. A Positron Emission Tomography (PET) drug
production facility licensed by a state or federal agency;
(3) The applicant submits the following
information:
a. The radionuclide;
b. The chemical and physical form;
c. The packaging including maximum activity
per vial, syringe, generator, or other container of the radioactive drug;
and
d. The shielding provided by
the packaging of the byproduct material shall be appropriate for safe handling
and storage of radiopharmaceuticals by group licensees in accordance with
He-P
4037.04; and
(4) The applicant satisfies the following
labeling requirements:
a. A label shall be
affixed to each transport radiation shield of a radioactive drug to be
transferred for commercial distribution;
b. The label shall include:
1. The radiation symbol and the words
"CAUTION, RADIOACTIVE MATERIAL" or "DANGER, RADIOACTIVE MATERIAL";
2. The name of the radioactive drug or its
abbreviation; and
3. The quantity
of radioactivity at a specified date and time, except in the case of
radioactive drugs with a half-life greater than 100 days, for which the time
may be omitted;
c. A
label shall be affixed to each syringe, vial, or other container used to hold a
radioactive drug to be transferred for commercial distribution;
d. The label required in He-P4032.05(a) (4)
c. shall include:
1. The radiation symbol and
the words "CAUTION, RADIOACTIVE MATERIAL" or "DANGER, RADIOACTIVE MATERIAL";
and
2. An identifier that ensures
that the syringe, vial, or other container can be correlated with the
information on the transport radiation shield label; and
e. The labels, leaflets, or brochures
required by He-P 4032.03(a) (4)
shall be in addition to the labeling
required by the Food and Drug Administration (FDA), and shall be separate from
or, if approved by the FDA may be combined with, the labeling required by
FDA.
(b) A licensee described by He-P 4032.05(a) (2) c. or (a) (2) d.:
(1) Shall prepare radioactive drugs for
medical use, and shall ensure that the radioactive drug is prepared by an
authorized nuclear pharmacist, as specified in
He-P
4032.05(b) (2) and (b) (3), or an
individual under the supervision of an authorized nuclear pharmacist, as
specified in He-P 4035;
(2) Shall
allow a pharmacist to work as an authorized pharmacist only if:
a. This individual qualifies as an authorized
nuclear pharmacist as defined in He-P 4035;
b. This individual meets the requirements
specified in He-P 4035 and the licensee has received an approved license
amendment identifying this individual as an authorized nuclear pharmacist;
or
c. This individual is designated
as an authorized nuclear pharmacist in accordance with
He-P
4032.05(b) (3) ;
(3) Shall name a pharmacist as defined in
He-P
4003.01(df) as an authorized nuclear
pharmacist as defined in
He-P
4035.03(c) , only if:
a. The individual was a nuclear pharmacist
preparing only radioactive drugs containing accelerator-produced radioactive
material; and
b. The individual
practiced at a pharmacy at a government agency or federally recognized Indian
Tribe before November 30, 2007 or at all other pharmacies before August 8,
2009, or an earlier date as noticed by the NRC;
(4) Shall provide to DHHS/RHS:
a. A copy of each individual's certification
by a specialty board whose certification process has been recognized by the
Nuclear Regulatory Commission or an agreement state as specified in
He-P
4035.74(a) with the written
attestation signed by a preceptor as required by
He-P
4035.74(b) (2) ; or
b. The Nuclear Regulatory Commission or
agreement state license or licensing state license; or
c. A Nuclear Regulatory Commission master
materials licensee permit; or
d.
The permit issued by a licensee of broad scope, or the authorization from a
commercial nuclear pharmacy authorized to list its own authorized nuclear
pharmacist; or
e. Documentation
that only accelerator-produced radioactive materials were used in the practice
of nuclear pharmacy at a government agency or federally recognized Indian Tribe
before November 30, 2007 or at all other locations of use before August 8,
2009, or an earlier date as noticed by the Nuclear Regulatory Commission;
or
f. A copy of the state pharmacy
licensure or registration, no later than 30 days after the date that the
licensee allows pursuant to
He-P
4032.05(b) (2) a. and (b) (2) c., the
individual to work as an authorized nuclear pharmacist;
(c) The actions authorized in He-P 4032.05(b) (1) and (b) (2) are permitted in spite of more restrictive language in license conditions.
(d) A licensee authorized under He-P 4032.05 shall:
(1) Possess and use instrumentation to
measure the radioactivity of radioactive drugs;
(2) Have procedures for use of the
instrumentation;
(3) Measure, by
direct measurement or by combination of measurements and calculations, the
amount of radioactivity in dosages of alpha-, beta-, or photon-, emitting
radioactive drugs prior to transfer for commercial distribution; and
(4) Perform tests before initial use,
periodically, and following repair, on each measurement instrument for
accuracy, linearity, and geometry dependence, as appropriate for the use of the
instrument, and make adjustments when necessary; and
(5) Check each measurement instrument for
constancy and proper operation at the beginning of each day of use.
(e) Nothing in this section relieves the licensee from complying with applicable FDA, other federal, and state requirements governing radioactive drugs.
(See Revision Note at part heading for He-P 4032) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07
New. #8959, eff 8-7-07
Disclaimer: These regulations may not be the most recent version. New Hampshire may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
