[Federal Register Volume 59, Number 231 (Friday, December 2, 1994)]
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From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-29525]


  Federal Register / Vol. 59, No. 231 / Friday, December 2, 1994 /
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[[Page Unknown]]

[Federal Register: December 2, 1994]


                                                   VOL. 59, NO. 231

                                           Friday, December 2, 1994

NUCLEAR REGULATORY COMMISSION

10 CFR Parts 30, 32, and 35

RIN 3150-AD69

 

Preparation, Transfer for Commercial Distribution, and Use of 
Byproduct Material for Medical Use

AGENCY: Nuclear Regulatory Commission.

ACTION: Final rule.

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SUMMARY: The Nuclear Regulatory Commission (NRC) is amending its 
regulations for the medical use of byproduct material. This action is 
being taken in response to a petition for rulemaking. This final rule 
is intended to provide greater flexibility by allowing properly 
qualified nuclear pharmacists and authorized users who are physicians 
greater discretion to prepare radioactive drugs containing byproduct 
material for medical use. This final rule, while allowing research 
involving human subjects using byproduct material, requires NRC 
licensees who conduct such research to obtain the informed consent of 
the human subjects and the prior review and approval of an 
``institutional review board'' within the meaning of the Federal Policy 
for the Protection of Human Subjects. This final rule also allows 
medical use of radiolabeled biologics. In addition, this final rule 
contains other miscellaneous and conforming amendments necessary to 
clarify or update the current regulations.

EFFECTIVE DATE: January 1, 1995.

ADDRESSES: Copies of the public record, including the final regulatory 
analysis and any public comments received on the proposed rule, may be 
examined and copied for a fee in the Commission's Public Document Room 
at 2120 L Street, NW. (Lower Level), Washington, DC.

FOR FURTHER INFORMATION CONTACT: Dr. Anthony N. Tse, Office of Nuclear 
Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 
20555, telephone (301) 415-6233.

SUPPLEMENTARY INFORMATION:

I. Background

The Petition for Rulemaking

    In early 1989, the American College of Nuclear Physicians (ACNP) 
and the Society of Nuclear Medicine (SNM) approached the NRC staff with 
concerns that the Commission's regulations failed to accommodate the 
functions and responsibilities of the practice of nuclear pharmacy. At 
the suggestion of the NRC staff, the ACNP and SNM submitted a petition 
for rulemaking requesting the Commission to amend its regulations to 
fully recognize the role of licensed nuclear pharmacists and 
physicians. On September 15, 1989 (54 FR 38239), the Commission 
published in the Federal Register a notice of receipt of a petition for 
rulemaking for public comment (PRM-35-9).
    During the development of the ACNP-SNM petition, one NRC staff 
member provided substantial assistance in the preparation of the 
petition. However, that individual has not participated in the NRC's 
resolution of the petition or in the development of this rule. Another 
NRC staff member reviewed the petition prior to its formal submittal to 
the Commission and participated, to some extent, in the NRC's 
resolution of the petition and in the development of the rule. The 
Commission, while aware of this background, considered the petition on 
its own merits.
    The petition included the following requests:
    A. The petitioners requested that authorized users who are 
physicians (physician authorized users) be given greater flexibility 
regarding the medical use of radiopharmaceuticals containing byproduct 
material. Specifically, the petitioners requested that these physicians 
be permitted to: (1) Use radiopharmaceuticals to treat diseases that 
are not listed in the U.S. Food and Drug Administration (FDA) approved 
package insert; (2) Use methods of administration of 
radiopharmaceuticals that are not listed in the package insert; (3) Use 
radiopharmaceuticals other than those for which the FDA has accepted an 
Investigational New Drug (IND) or an approved New Drug Application 
(NDA); (4) Prepare radiopharmaceuticals using radionuclide generators 
and reagent kits in a manner other than in accordance with the 
manufacturer's instructions; and (5) Compound radiopharmaceuticals in 
accordance with State law.
    B. The petitioners requested that the NRC recognize the practice of 
nuclear pharmacy and the certification of nuclear pharmacists by the 
Board of Pharmaceutical Specialties. Specifically, the petitioners 
requested that nuclear pharmacists be permitted to: (1) Compound 
radiopharmaceuticals as allowed by State or FDA regulations; (2) 
Compound radiopharmaceuticals whose manufacture and distribution are 
not regulated by the State or FDA; (3) Prepare radiopharmaceuticals 
using radionuclide generators and reagent kits in a manner other than 
in accordance with the manufacturer's instructions; (4) Produce reagent 
kits; and (5) Dispense radiopharmaceuticals that are not regulated by 
the FDA.
    C. Additionally, the petitioners requested that the NRC: (1) Permit 
categories of research using radioactive drugs that do not require an 
IND, such as research approved by a Radioactive Drug Research Committee 
(RDRC); (2) Permit the use of radiolabeled biologics for which the FDA 
has issued a license in response to a product license application 
(PLA); and (3) Clarify its regulations pertaining to specific licenses 
of broad scope.

Earlier NRC Efforts

    In response to the Federal Register notice that announced the 
receipt of the petition, 466 comment letters were received. About 99 
percent of the commenters supported and agreed with the petition. After 
consideration of the public comment letters and consultation with the 
FDA staff, the Commission determined that some issues should be 
addressed promptly.
    On August 23, 1990 (55 FR 34513), the Commission published an 
Interim Final Rule to allow, for a period of 3 years, the use of 
therapeutic radiopharmaceuticals for indications not listed in the 
package insert and to allow departures from the manufacturer's 
instructions for preparing diagnostic radiopharmaceuticals using 
radionuclide generators and reagent kits. On July 22, 1993, the 
Commission extended the expiration date of the Interim Final Rule from 
August 23, 1993, to December 31, 1994. The action allows licensees to 
continue to use byproduct material under the provisions of the Interim 
Final Rule until the Commission completes this final rule.
    In a parallel effort, the NRC continued to work on the remaining 
issues in the ACNP-SNM petition. On August 7, 1991, the NRC conducted a 
public workshop in Rosemont, Illinois, to present ``strawman'' language 
on the training and experience criteria for authorized nuclear 
pharmacists to representatives of the following organizations: Board of 
Pharmaceutical Specialties, American Board of Science in Nuclear 
Medicine, National Association of Boards of Pharmacy, Committee on 
Radionuclides and Radiopharmaceuticals of the U.S. Council for Energy 
Awareness, American Pharmaceutical Association, American Society of 
Hospital Pharmacists, and three graduate schools of pharmacy. 
Subsequently, the NRC also discussed the proposed resolution of these 
issues in meetings with the FDA, the NRC's Advisory Committee on the 
Medical Uses of Isotopes (ACMUI), and the Agreement States. This 
rulemaking is the evolutionary result of numerous meetings with the 
aforementioned groups.

NRC's Policy

    In a policy statement published on February 9, 1979 (44 FR 8242), 
entitled ``Regulation of the Medical Uses of Radioisotopes; Statement 
of General Policy,'' the NRC stated:
    1. The NRC will continue to regulate the medical uses of 
radioisotopes as necessary to provide for the radiation safety of 
workers and the general public.
    2. The NRC will regulate the radiation safety of patients where 
justified by the risk to patients and where voluntary standards, or 
compliance with these standards, are inadequate.
    3. The NRC will minimize intrusion into medical judgments affecting 
patients and into other areas traditionally considered to be a part of 
the practice of medicine.
    In conformance with this policy, the Commission is eliminating 
certain restrictions in the NRC regulations on the practices of 
medicine and pharmacy (e.g., compounding), and is providing the 
authority for research involving human subjects and the use of 
radiolabeled biologics. The Commission believes that these restrictions 
can be eliminated without compromising the level of protection of 
public health and safety against radiological hazards. The Commission 
recognizes that physicians have the primary responsibility for the 
diagnosis and treatment of their patients or human research subjects 
and recognizes that nuclear pharmacists have the primary responsibility 
for the preparation of radioactive drugs. NRC regulations are 
predicated on the assumption that properly trained and adequately 
informed physicians and pharmacists will make decisions that are in the 
best interest of their patients or human research subjects. 
Furthermore, the pharmacological aspects of radioactive drugs, 
including drug safety and efficacy, are regulated by the FDA or the 
States.

II. The Proposed Rule, Public Comments, and NRC Responses

    The Commission published the proposed rule in the Federal Register 
on June 17, 1993 (58 FR 33396), and provided a 120-day public comment 
period. About 2,500 copies of the notice of the proposed rulemaking 
were mailed to all applicable NRC licensees, Agreement State and Non-
Agreement State agencies, and other interested groups.
    The NRC received 284 comment letters in response to the proposed 
rule. There were 280 letters in support of the proposed rule, 1 letter 
in opposition to the proposed rule, and 3 letters provided comments 
without specifically indicating support for or opposition to the 
proposed rule. There were 182 letters from individuals working in 
commercial pharmacies, 3 from pharmaceutical manufacturers, 6 from 
hospitals, 7 from professional associations, 6 from universities, 5 
from governmental agencies, and 75 who did not indicate their 
affiliations. In terms of commenters' professions or qualifications, 
the vast majority of letters were from pharmacists.
    Public comments and the NRC's responses are presented below. 
General comments are presented first, followed by specific comments 
associated with individual sections of the rule for which comments were 
received. The discussion of the changes in the proposed rule language 
is presented in section III entitled ``Discussion of Final Rule Text.'' 
Referring to section V, entitled ``Text of Final Regulations,'' may 
expedite the reader's understanding of the public comments and the 
NRC's responses.

General Comments

    (1) Comment. The NRC is ``straying very far'' from its mandate and 
competence in regulating the medical uses of byproduct material. The 
commenter appended a copy of section 104 of the Atomic Energy Act, 
entitled ``Medical Therapy and Research and Development,'' as rationale 
for the commenter's viewpoint.
    Response. The Commission's statutory mandate in the Atomic Energy 
Act of 1954, as amended, includes all uses of byproduct, source, and 
special nuclear material. Specifically, section 81 of the Act 
prohibits, without Commission authorization, the manufacture, 
production, transfer, receipt in interstate commerce, acquisition, 
ownership, possession, import, or export of byproduct material (42 
U.S.C. 2111). Also, section 161 of the Act states (in part):

    The Commission is authorized to establish by rule, regulation, 
or order, such standards and instructions to govern the possession 
and use of special nuclear material, source material, and byproduct 
material as the Commission may deem necessary or desirable to 
promote the common defense and security or to protect health or to 
minimize danger to life or property (emphasis added).

Therefore, the Commission has broad statutory responsibility to 
regulate all uses of byproduct material, including medical use.
    Section 104(a) of the Atomic Energy Act states:

    The Commission is authorized to issue licenses to persons 
applying therefor for utilization facilities for use in medical 
therapy. In issuing such licenses the Commission is directed to 
permit the widest amount of effective medical therapy possible with 
the amount of special nuclear material available for such purpose 
and to impose the minimum amount of regulation consistent with its 
obligations under this Act to promote the common defense and 
security and to protect the health and safety of the public (42 
U.S.C. 2134(a)) (emphasis added).

    Section 104(a) on its face applies only to medical therapy 
licensees for using ``utilization facilities'' (i.e., nuclear reactors) 
and ``special nuclear material.'' No ``minimum regulation'' directive 
governs the Commission's regulation of byproduct material. This section 
does not even apply to the medical use of byproduct material, which 
falls within the NRC's broad standard-setting authority in sections 81 
and 161 of the Act. Even if the commenter were correct that the NRC had 
a statutory obligation to minimize regulation, this rule eliminates 
certain restrictions in the regulation of the medical use of byproduct 
material, furthering that purpose. The Commission is, in fact, imposing 
the minimum amount of regulation commensurate with the need for 
protection of the public health and safety.
    Regarding the NRC's competence, ``[t]he substantive area in which 
an agency is deemed to be expert is determined by statute.'' 
Massachusetts v. United States, 856 F.2d 378, 382 (1st Cir. 1988). See 
also Commonwealth of Massachusetts v. NRC, 924 F.2d 311, 324 (D.C. 
Cir.), cert. denied, 112 S.Ct. 275 (1991). The Atomic Energy Act 
commits to the NRC the duty of regulating the use of byproduct 
materials, including radioactive drugs, to protect public health and 
safety and as a matter of law the NRC is deemed ``expert'' in making 
technical and policy judgements in this field.
    The NRC has long experience in regulating nuclear medicine and 
``[i]n recent years has increased its recruitment of personnel who have 
experience and knowledge either in nuclear medicine or in radiation 
therapy'' (56 FR 34104; July 25, 1991). Since the Commission's 
inception, it has been accountable for the regulation of medical uses 
of byproduct material. It has licensed, inspected, collected and 
analyzed data in this field for many years, and has issued and 
administered various forms of regulations.
    Furthermore, this rulemaking is not about what dosage of a 
radioactive drug should be prescribed to treat or diagnose a patient. 
It is about the qualifications of individuals performing NRC-licensed 
activities (e.g., authorized nuclear pharmacists) that are necessary to 
protect the health and safety of patients and workers from radiological 
hazards. This rule, in other words, does not intrude on medical 
judgment. Moreover, the NRC has highly qualified staff and extensive 
experience in determining radiation safety qualifications.
    In addition, the NRC has an advisory committee (the Advisory 
Committee on the Medical Uses of Isotopes or ``ACMUI''), which, since 
its establishment many years ago, has advised the NRC on rulemakings 
and other initiatives related to the medical uses of byproduct 
material. The membership of the ACMUI includes a broad spectrum of 
expertise, such as physicians (i.e., in nuclear medicine, cardiology, 
and radiation oncology), medical physicists, pharmacists, medical 
researchers, practicing technologists, hospital administrators, state 
medical regulators, Food and Drug Administration representatives, and a 
patient rights representative. The NRC also has a visiting medical 
fellows program that allows selected physicians or pharmacists to work 
for NRC for a period of 1 to 2 years. Both ACMUI and the visiting 
medical fellows provided advice to the NRC during the development of 
this rule.
    (2) Comment. The NRC is attempting to duplicate regulation by other 
federal, state, and national entities which already have appropriate 
responsibility in the areas of medicine and pharmacy.
    Response. This final rule is not duplicating regulation by other 
federal or state agencies. In fact, this rule is designed to avoid 
duplication of the regulations of other federal agencies (e.g., see 
response to comments on Sec. 35.6). In the area of medical use of 
byproduct material, the NRC and FDA signed a Memorandum of 
Understanding (58 FR 47300; September 8, 1993) to coordinate existing 
NRC and FDA regulatory programs. Generally speaking, FDA regulates the 
manufacture and distribution of radioactive drugs and medical devices 
for safety and efficacy, while the NRC regulates radiation safety 
associated with the actual use of these products.
    (3) Comment. The preamble to the proposed rule gives the impression 
that the NRC would allow nuclear physicians and nuclear pharmacists to 
use unregulated, dangerous radioactive drugs. In addition, a commenter 
stated that, under State Pharmacy law, a licensed pharmacist may 
delegate certain duties to non-pharmacist individuals if the pharmacist 
provides ``direct supervision.'' Is it the NRC's intent to permit the 
authorized nuclear pharmacist to delegate the full range of 
professional duties to non-pharmacist individuals?
    Response. The preamble to the proposed rule stated that a licensee 
must meet the Commission's regulations regarding radiation safety of 
the workers and the public, including patients, and that the licensee 
is not relieved from complying with applicable FDA, other Federal, and 
State requirements governing radioactive drugs. Because the FDA and 
States regulate the safety and efficacy of radioactive drugs, the 
licensee must also follow their regulations when using radioactive 
drugs. The Commission will allow an authorized nuclear pharmacist to 
delegate a full range of duties to a non-pharmacist individual provided 
that the individual is properly supervised (i.e., according to 
Sec. 35.25).
    (4) Comment. The final rule should be effective immediately upon 
publication in the Federal Register instead of being effective 6 months 
after publication.
    Response. The Commission agrees that licensees may not need 6 
months to implement this final rule. However, with limited exceptions, 
section 553(d) of the Administrative Procedure Act (APA) provides that 
``[t]he required publication or service of a substantive rule shall be 
made not less than 30 days before its effective date.'' The commenter 
has not persuaded the NRC that good cause exists for making immediately 
effective this final rule, which in part, imposes new substantive 
requirements. Therefore, the effective date will be 30 days after 
publication of this rule in the Federal Register.
    (5) Comment. The NRC should provide a mechanism for 
``grandfathering'' qualified nuclear pharmacists who are currently 
working in hospital-based nuclear pharmacies, similar to the mechanism 
proposed for ``grandfathering'' qualified individuals working in 
commercial nuclear pharmacies.
    Response. The Commission agrees with this comment because a 
qualified nuclear pharmacist should be ``grandfathered'' regardless of 
whether the individual is currently working in a commercial nuclear 
pharmacy or a hospital-based nuclear pharmacy. Therefore, Sec. 35.981 
entitled ``Training for experienced nuclear pharmacists,'' has been 
added to this final rule. This section is similar to Sec. 32.72 in the 
proposed rule for ``grandfathering'' qualified individuals working in 
commercial nuclear pharmacies. The Commission believes that this 
limited ``grandfathering'' is justified provided: (1) This individual 
is currently working in a nuclear pharmacy; (2) this individual has 
completed a structured educational program as specified in 
Sec. 35.980(b)(1); and (3) the qualifications of this individual would 
be reviewed and approved by NRC before a licensee may allow this 
individual to work as an authorized nuclear pharmacist.
    (6) Comment. Several commenters requested that the following items 
be addressed in this rulemaking: (a) Handling of brachytherapy 
radioactive sources for temporary implants related to I-125 eye 
plaques, wherein the patient goes home and returns several days later 
for removal of the sources; (b) Changing the person who signs the 
records of sealed source leak tests, sealed source inventories, and 
surveys of sealed source storage areas from the Radiation Safety 
Officer to the individual who performs these tasks; and (c) Permitting 
licensees to allow Radiation Safety Officers who meet certain 
requirements to work without first obtaining a license amendment 
(similar to the provisions proposed for authorized users and authorized 
nuclear pharmacists).
    Response. These items will not be addressed because they are beyond 
the scope of this rulemaking.

Specific Comments

Section 32.72  Manufacture, Preparation, or Transfer for Commercial 
Distribution of Radioactive Drugs Containing Byproduct Material for 
Medical Use Under 10 CFR Part 35
    Several commenters addressed the use of the term ``radioactive 
drug.'' These comments and the NRC's responses are summarized below.
    (1) Comment. One commenter stated that ``the FDA has a specific 
definition which it uses for radiopharmaceuticals, and I am not aware 
that it will similarly replace this word with that of radioactive 
drug.'' Also, the commenter questioned whether the term ``radioactive 
drug'' included radiolabeled biologics.
    Response. FDA regulations define the term ``radioactive drug'' (21 
CFR 310.3) but do not define the term ``radiopharmaceutical.'' As 
stated in the preamble to the proposed rule, the term ``radioactive 
drug'' includes a radiolabeled biologic, which is an accurate usage for 
both NRC and FDA regulations.
    (2) Comment. The medical use of byproduct material may be approved 
by the FDA as a radioactive drug or a device. If it is approved as a 
device, not a radioactive drug, would the proposed changes create 
regulatory barriers in such situations?
    Response. This rule does not impose any new regulatory requirements 
for the use of devices containing byproduct material. Therefore, this 
rule would not create regulatory barriers for the use of such devices.
Section 32.72(a)(2)
    Several commenters requested clarification concerning the proposed 
requirement that a nuclear pharmacy or a drug manufacturer must obtain 
a Part 32 license. These comments and the NRC's responses are 
summarized below.
    (1) Comment. The NRC should continue to permit Part 33 or 35 
medical use licensees to share a nuclear pharmacy without requiring a 
Part 32 license.
    Response. The Commission currently permits the nuclear pharmacy of 
a Part 33 or 35 medical use licensee to distribute radioactive drugs to 
a limited set of medical use licensees through a license amendment 
approval on a case-by-case basis. This is the context in which such 
licensees may ``share'' a nuclear pharmacy. The Commission believes 
that Part 33 or 35 licensees who have been granted this authority could 
continue to operate a nuclear pharmacy provided that the nuclear 
pharmacy:
    (i) Complies with the safety requirements specified in 10 CFR 
32.72(a)(3), (a)(4), and (c);
    (ii) Is operated by a medical use licensee; and
    (iii) Only engages in limited distribution to a specified set of 
medical use licensees but does not engage in commercial distribution.
    Other Part 33 or 35 medical use licensees seeking this authority 
must first apply for a license amendment and receive an authorization 
for limited distribution pursuant to Part 32. The fees specified in 
Category 3C of 10 CFR 170.31 and 10 CFR 171.16 are assessed for this 
type of authorization. As provided in footnote 1(d)(2) of 10 CFR 
170.31, there is an application fee (fee Category 3C) to add this type 
of authorization. Upon issuance of the license amendment adding this 
authorization, the licensee will be subject to the licensing and 
inspection fees in fee Category 3C of 10 CFR 170.31 and the annual fees 
in fee Category 3C of 10 CFR 171.16. These fees are in addition to any 
other fee categories covered by the existing license.
    However, in those cases where a small number of Part 35 licensees 
wish to transfer unsealed byproduct material among themselves, the NRC 
will consider granting an exemption pursuant to 10 CFR 35.19. 10 CFR 
170.31 (footnote 2) specifies the fees for such exemption requests. For 
existing Part 35 licensees, requests for an exemption under 10 CFR 
35.19 are subject to the amendment fees specified in 10 CFR 170.31, or 
fee Category 7B or 7C, as applicable.
    (2) Comment. The NRC should continue to permit Part 33 licensees 
who are authorized to produce radioactive drugs to be used only for 
research experiments to distribute these drugs to medical use 
licensees.
    Response. The Commission currently permits such a Part 33 licensee 
to distribute, on a limited basis, radioactive drugs to be used only 
for research experiments through a license amendment approval on a 
case-by-case basis. The Commission believes that Part 33 licensees who 
have been granted this authority could continue to distribute these 
drugs provided that the Part 33 licensee complies with safety 
requirements specified in 10 CFR 32.72(a)(3), (a)(4), and (c). Other 
Part 33 licensees seeking this authority must first apply for a license 
amendment and receive an authorization for limited distribution 
pursuant to Part 32. This type of authorization is subject to the fees 
specified in fee Category 3C of 10 CFR 170.31 and 171.16. As provided 
in footnote 1(d)(2) of 10 CFR 170.31, there is an application fee (fee 
Category 3C) to add this type of authorization. Upon issuance of the 
license amendment adding this authorization, the licensee will be 
assessed the licensing and inspection fees in fee Category 3C of 10 CFR 
170.31 and the annual fees in fee Category 3C of 10 CFR 171.16. These 
fees are in addition to any other fee categories covered by the 
existing license.
Section 32.72(a)(4).
    There were numerous comments addressing the labeling requirements. 
These comments and NRC's responses are summarized below.
    (1) Comment. Several commenters stated that the NRC has no legal 
jurisdiction over drug labeling and should not require drug labeling 
because it is regulated by the FDA. Another commenter supported the 
proposed labeling requirements and stated that its facility has already 
included all information specified in the proposed rule.
    Response. The Commission has broad authority under sections 81 and 
161 of the Atomic Energy Act, as amended, including authority to 
establish by rule, regulation, or order, such standards and 
instructions to govern the possession and use of byproduct material. 
Therefore, the Commission has jurisdiction to require labeling of 
radioactive drugs containing byproduct material and is currently 
requiring that specific information be included on labels.
    The Commission's labeling requirements are not intended to 
duplicate FDA requirements, but are intended to provide information 
related to radiation safety. These labels are needed for:
    (i) Hospital workers to ensure that the radioactive drug is the 
correct drug and the correct dosage; and
    (ii) Transport workers to identify the contents of a vial, 
container, or package, and to take appropriate actions in the event of 
any transportation accident.
    (2) Comment. It would be very costly to have inspectors check 12 
million drug labels. The commenter believes that this activity would be 
entirely cost-ineffective.
    Response. The modifications to current Sec. 32.72(a)(4) are 
intended to clarify the existing labeling requirements, except for the 
addition of ``time of assay.'' Thus, the Commission believes that 
licensees will not incur significant additional cost associated with 
these modifications. In terms of inspections, the NRC inspectors do not 
check the label of every container or package of a radioactive drug. 
They may conduct spot checks. Thus, there will not be a significant 
cost for NRC inspectors either.
    (3) Comment. The syringe label should not be limited to the 
clinical procedure. On the other hand, it is unnecessary to require 
that the label, or the leaflet or brochure that accompanies the 
radioactive drug, contain all of the statements specified in the 
proposed rule.
    Response. The regulatory text in this section states: ``In 
addition, the label for the syringe or syringe radiation shield must 
also contain the clinical procedure to be performed or the patient's or 
the human research subject's name.'' Thus, the clinical procedure is an 
additional item but not the only item on the label.
    Regarding the statements that must be included in the leaflet or 
brochure, the Commission believes these statements are necessary 
because they serve as warnings to individuals who are not authorized to 
use the byproduct material. However, the statement that ``other 
regulatory approvals may be required'' has been deleted because this 
concern is already covered by 10 CFR 35.7.
    (4) Comment. It is unclear as to the legal origin of the statement 
that ``NRC's labeling requirements are independent of requirements of 
the U.S. Food and Drug Administration (FDA).''
    Response. This comment quotes the last sentence of Sec. 32.72(a)(4) 
of the proposed rule, stating that: ``NRC's labeling requirements are 
independent of requirements of the U.S. Food and Drug Administration 
(FDA).'' This comment appears to question the NRC's statutory authority 
for the quoted statement. As previously stated in response to comment 1 
on Sec. 32.72(a)(4), the NRC's statutory authority to impose 
requirements with respect to the labeling of radioactive drugs 
containing byproduct material derives from its authority under the 
Atomic Energy Act (primarily sections 81 and 161b) to regulate 
byproduct material. The quoted sentence makes it clear that NRC's 
labeling requirements are separate from the labeling requirements of 
FDA.
Section 32.72(b)
    There were several comments concerning this paragraph. These 
comments and the NRC's responses are discussed below.
    (1) Comment. The phrase ``within 30 days of the date'' used in the 
proposed Sec. 32.72(b)(3) is confusing and should be replaced with ``no 
later than 30 days after the date.''
    Response. The Commission agrees with the comment. The final rule 
text has been modified accordingly.
    (2) Comment. In the preamble of the proposed rule discussing 
proposed Sec. 32.72(b)(3), the use of the phrase ``individual's 
character'' in determining whether the individual should be approved as 
an authorized nuclear pharmacist appears inappropriate.
    Response. The NRC disagrees with this comment. Under sections 182 
and 183 of the Atomic Energy Act, the Commission has broad authority 
over the scope of license applications and the terms of licenses. 
Section 182(a) includes the authority to require, by rule or 
regulation, such information as the Commission determines necessary to 
decide, among other things, the technical and other qualifications of 
the applicant as the Commission may deem appropriate, as well as the 
applicant's character. Therefore, in determining whether to grant a 
license or license amendment, or approve an individual to perform 
licensed activities, the NRC can consider the past performance and 
character (which may include activities involving improper or illegal 
practices) of the license applicant, the licensee, or the individual 
who is to perform licensed activities. An individual occupying the 
position of a physician authorized user or authorized nuclear 
pharmacist has the potential to affect the public health and safety. 
Accordingly, it would be appropriate for the NRC to consider 
information relating to that individual's ``character.''
    (3) Comment. If an authorized nuclear pharmacist decides not to 
seek recertification as a Board Certified Nuclear Pharmacist, would the 
individual lose the authorized nuclear pharmacist status?
    Response. No. If an individual gained authorized nuclear pharmacist 
status based on board certification and decided not to seek 
recertification, this individual may continue to work as an authorized 
nuclear pharmacist provided this individual continues to be identified 
as an authorized nuclear pharmacist on a Commission or Agreement State 
license or on a permit issued by a Commission or Agreement State 
licensee of broad scope.
    (4) Comment. Would the scope of ``grandfathering'' extend beyond 
the initial transition period?
    Response. The Commission believes it is not necessary to limit the 
``grandfathering'' provision to a definite period after the effective 
date of this final rule. Therefore, there is no time limit for the 
``grandfathering'' provision.
Section 32.72(c)
    There were several comments concerning instrumentation. These 
comments and the NRC's responses are discussed below.
    (1) Comment. The proposed requirements for linearity and geometry 
tests are not consistent with methods of assaying alpha or beta 
emitters, such as liquid scintillation counting.
    Response. The regulatory text includes the phrase ``as appropriate 
for the use of the instrument.'' Therefore, if linearity or geometry 
tests are not appropriate for an instrument, the tests are not 
required.
    (2) Comment. The regulation does not require medical use licensees 
to measure the activity of a unit dosage of an alpha- or a beta-
emitting radionuclide. This provision should also apply to commercial 
nuclear pharmacies.
    Response. Section 35.52(a) will exempt a medical use licensee from 
measuring the alpha- or beta-activity of a unit dosage, if the licensee 
obtains that unit dosage from a commercial nuclear pharmacy. This 
exemption is acceptable because Sec. 32.72(c) will require the 
commercial nuclear pharmacy to measure that activity before dispensing 
the radioactive drug. Commercial nuclear pharmacies would be required 
to measure the alpha- or beta-activity of a unit dosage because, 
otherwise, it might not be measured by anyone. Therefore, this 
provision cannot be applied to commercial nuclear pharmacies.

Authorized Nuclear Pharmacist

    There were several comments concerning this definition. These 
comments and the NRC's responses are summarized below.
    (1) Comment. This definition uses the phrase ``a permit issued by a 
Commission or Agreement State specific licensee of broad scope.'' Is 
there a standard format for this permit?
    Response. The Commission does not require licensees of broad scope 
to use a standard format for a permit. The format for this permit may 
vary from one licensee to another.
    (2) Comment. The word ``or'' should be inserted between the first 
and second paragraphs of this definition.
    Response. It is an acceptable regulatory drafting convention that 
for a sentence with multiple independent conditions, only one ``or'' is 
necessary between the last condition and the previous condition to 
indicate that satisfying any one of the conditions is acceptable. 
Because this definition has three independent conditions, an ``or'' 
between the first and the second condition is not necessary.

Authorized User

    Comment. There were several comments concerning the use of the 
phrase ``individual's character'' in the preamble of the proposed rule. 
The commenters stated that the use of the phrase ``individual's 
character'' appears inappropriate in considering whether the individual 
should be approved as an authorized user.
    Response. For the same reasons as set forth in response to comment 
(2) of Sec. 32.72(b), the Commission disagrees with the comment.

Medical Use

    There were several comments concerning the addition of human 
research subjects in the definition of medical use. These comments and 
the NRC's responses are summarized below.
    (1) Comment. By including human research subjects under ``medical 
care,'' it is implied that a physician may be allowed to deliver any 
radiation dose to a human research subject if the physician can 
convince the local IRB that the dose is warranted. Also, the concept of 
implying that human research subjects can be considered as patients may 
cause difficulty because there are separate laws and considerations for 
each group.
    Response. The definition under discussion is ``medical use,'' not 
``medical care.'' The term ``medical use'' is specifically defined for 
the purpose of identifying a class of uses involving byproduct material 
that is regulated by the Commission. By using the term ``patients or 
human research subjects'' in connection with a requirement, the 
Commission states that the requirement applies to both patients and 
human research subjects. The Commission does not intend to imply that a 
human research subject can be considered as a patient, nor does the 
Commission intend to imply that a physician may deliver any radiation 
dose to a human research subject, without appropriate approval.
    The Commission recognizes that there are separate medical or 
pharmacy laws and considerations governing human research subjects and 
patients. However, the Commission has determined that the radiation 
safety requirements in its regulations that are designed to protect 
patients from radiological hazards are equally applicable to human 
research subjects.
    (2) Comment. There could be some difficulty when applying the 
quality management program to human research subjects. Also, annual 
review of human use studies is redundant of FDA regulations.
    Response. The quality management program (QMP) applies only to 
research procedures using quantities of byproduct material specified in 
Sec. 35.32(a)(1). However, because most research procedures use 
quantities of byproduct material that are less than those specified in 
Sec. 35.32, the QMP would not be required for these research 
procedures.
    The review specified in Sec. 35.32(b) applies only to human 
research procedures for which written directives are required. The 
review includes evaluation of a representative sample of 
administrations, recordable events, and misadministrations, to verify 
compliance with the QMP. These evaluations are specifically related to 
the requirements in the Commissions's regulations, which are not 
redundant of FDA regulations.
Section 35.6  Provisions for Research Involving Human Subjects
    In the preamble of the proposed rule, the Commission solicited 
public comment on the number and type of research activities which 
would not be funded by another Federal agency which has adopted the 
Federal Policy and which would require a license amendment under the 
proposed rule. No comments on the number and type of such research 
activities were received.
    Also, the Commission solicited public comment on whether it should 
broaden or narrow its focus to require compliance with all or none of 
the provisions of the Federal Policy or equivalent license conditions. 
The Commission stated that in making these comments, consideration 
should be given to the fact that all radiation safety provisions of 10 
CFR part 35 would be made applicable to research involving human 
subjects. Several comments were received related to this topic. These 
comments and the NRC's responses are summarized below.
    (1) Comment. Omit all regulation of human research with radioactive 
material because the FDA handles this very nicely.
    Response. The Commission cannot omit all such regulation because it 
has the responsibility for ensuring adequate protection of public 
health and safety related to the use of byproduct material, including 
uses involving human research subjects.
    In view of the fact that this final rule would specifically permit, 
in certain circumstances, NRC licensees to use radioactive drugs 
containing byproduct material for research involving human subjects, 
the Commission has the responsibility to address the protection of the 
rights of those human subjects. At a minimum, this final rule requires 
NRC licensees who conduct such research to obtain the informed consent 
of the human research subjects and the prior review and approval of an 
IRB, within the meaning of the Federal Policy for the Protection of 
Human Subjects. These requirements apply whether or not the research is 
conducted, funded, supported, or regulated by another federal agency 
which has implemented this Federal Policy or is approved by the 
amendment of an NRC license. However, NRC licensees whose human 
research is covered by the Federal Policy as adopted by another federal 
agency, may conduct such research without prior NRC approval. In this 
way, the provisions of this rule are designed to avoid duplication of 
the regulations of other federal agencies which have adopted the 
Federal Policy, including the FDA.
    (2) Comment. The NRC should take steps to ensure that all 
provisions of the Federal Policy for the Protection of Human Subjects 
are met.
    Response. The basic safety objectives and ethical principles of the 
Federal Policy will be met by requiring licensees to obtain the 
informed consent of the human research subjects and prior approval by 
an IRB. However, some provisions of the Federal Policy are not directly 
applicable to the Commission's oversight of its licensees, such as the 
``Use of Federal Funds,'' ``Evaluations of Proposals for Research to be 
Conducted or Supported by a Federal Department or Agency,'' and ``Early 
Termination of Research Support.'' Therefore, NRC does not need to take 
steps to ensure that all provisions are met.
    On the other hand, the proposed rule did not explicitly state that 
the required informed consent and IRB approval must be in accordance 
with the provisions of the Federal Policy for the Protection of Human 
Subjects. Therefore, a phrase ``in accordance with the meaning of these 
terms as defined and described in the Federal Policy for the Protection 
of Human Subjects'' has been added to the text of the final rule to 
clarify this point.
    There were comments concerning the addition of ``human research 
subjects'' in the definition of ``medical use'' and the broadening of 
the quality management program to include human research subjects. 
These comments and NRC's responses are summarized in the discussion of 
the definition of ``medical use'' under Sec. 35.2.
Section 35.14  Notification
    Comment. Several commenters stated that the phrase ``within 30 days 
of the date'' in the proposed Sec. 32.72(b)(3) may be misinterpreted 
and suggested that a new phrase ``no later than 30 days after the 
date'' should be used.
    Response. See response to comment (1) of section 32.72(b).
Section 35.22  Radiation Safety Committee
    Comment. There were two comments concerning this section. One 
commenter agreed with the proposed change. The other commenter stated 
that the proposed change was not warranted because the Radiation Safety 
Committees (RSC) are overburdened by other duties.
    Response. The Commission believes that it is important for the RSC 
to review the training and experience of authorized users and 
authorized nuclear pharmacists and to approve or disapprove any such 
individuals because this review and the approval or disapproval by RSC 
is a key factor in the program to ensure radiation safety. Furthermore, 
existing regulations already require the RSC to perform such review and 
approval or disapproval of authorized users, Radiation Safety Officers, 
and teletherapy physicists. By adding authorized nuclear pharmacists to 
the review and approval or disapproval process of the RSC, the 
Commission does not believe that a significant burden will be added to 
the RSC's responsibilities because it is expected that a relatively 
small number of authorized nuclear pharmacists will be included in Part 
35 licenses.
Section 35.25  Supervision
    Comment. Several commenters stated that this section should not be 
so restrictive and that instructions to workers can only be provided by 
the supervising individuals. These commenters suggested that the 
provision for instructing workers may be delegated to other qualified 
individuals. Similarly, they suggested that periodic review of the work 
of the supervised individuals may also be delegated to other qualified 
individuals.
    Response. The Commission agrees that the workers may be instructed 
by the licensee, the supervising individuals, or other qualified 
individuals as long as the instructors are knowledgeable about the 
subject areas. The regulatory text has been revised to indicate that 
although the licensee may delegate these tasks to other qualified 
individuals, the licensee retains the responsibility for instructing 
workers.
    However, the requirement for periodically reviewing the work of 
supervised individuals remains with the supervising authorized nuclear 
pharmacist or physician authorized user. The Commission believes that 
the supervising individual is in a better position to review the work 
than another individual.
Section 35.27  Visiting authorized user.
    Comment. One commenter suggested that this section should be 
retained. The commenter stated that the paperwork associated with the 
proposed notification (Sec. 35.14) would be unduly burdensome for 
temporary authorized users who provide coverage during another 
authorized user's vacation or sickness.
    Response. The Commission disagrees with the commenter. When 
allowing a temporary authorized user to work, the licensee does not 
need to notify the NRC each time that the individual provides coverage 
during another authorized user's vacation or sickness. Under the 
notification requirement (Sec. 35.14), the licensee needs to notify the 
NRC no later than 30 days after the date the licensee permits the 
individual to work as a temporary authorized user. The next 
notification is when that individual permanently discontinues as a 
temporary authorized user. A notification is not required during each 
period of coverage between the beginning and the termination of the 
service of the temporary authorized user. This notification procedure 
also applies to a temporary authorized nuclear pharmacist. Thus, this 
section has been removed.
Section 35.50  Possession, Use, Calibration, and Checks of Dose 
Calibrators.
    Several comments were received related to this section. These 
comments and NRC's responses are summarized below.
    (1) Comment. The proposed phrase ``over the range of its use 
between the highest dosage that will be administered to a patient or 
human research subject and 1.1 megabecquerels (30 microcuries)'' should 
be clarified. ``Over the range of its use'' could mean between the 
highest and lowest dosages that will be administered; the lowest dosage 
may not be 1.1 megabecquerels.
    Response. The Commission agrees with the comment. The final 
amendment will be modified to delete the phrase ``over the range of its 
use.''
    (2) Comment. Linearity tests for a dose calibrator should cover the 
range from the highest patient dosage to the lowest patient dosage that 
will be administered by a licensee. The lowest dosage could be in 
millicurie quantities for many licensees. Thus, it is not necessary to 
test linearity to 1.1 megabecquerels (30 microcuries).
    Response. The intent of changing the lower limit of the linearity 
tests from 10 microcuries to 30 microcuries is to conform with the 
requirements of the Quality Management Program (Sec. 35.32) and to 
relieve a minor burden for measuring activities between 10 and 30 
microcuries without reducing radiation safety. To go beyond this by 
changing this limit to the lowest patient dosage would have 
ramifications on the constancy checks, accuracy tests, and 
recordkeeping requirements (i.e., Secs. 35.50(b)(1), (b)(2), and 
(b)(3); and 35.53(a), (b), and (c)(3)). Therefore, deleting this 
specific lower limit is beyond the scope of this rulemaking.
    (3) Comment. In expressing the units in both English units and SI 
units, English units should be first, followed by SI units in 
parentheses. Also, is there any scientific rationale for the precision 
implied by 1.1 mBq, instead of using 1 mBq?
    Response. The Commission published a policy statement entitled 
``Conversion to the Metric System'' (57 FR 46202; October 7, 1992). 
This policy statement specifies that the first unit will be in the SI 
unit with the English unit shown in brackets. In terms of significant 
digits, the implied uncertainty for 30 microcuries is somewhere between 
29 and 31 microcuries and for 1.1 mBq is somewhere between 1.0 and 1.2 
mBq. If 1 mBq is used, the implied precision would be less. Therefore, 
1.1 mBq has been retained in the final rule.
Section 35.52  Possession, Use, Calibration, and Checks of 
instrumentation to measure dosages of alpha- or beta-emitting 
radionuclides.
    There were several comments concerning this section. These comments 
and the NRC's responses are discussed below.
    (1) Comment. The proposed requirements for linearity and geometry 
tests are not consistent with methods of assaying alpha or beta 
emitters, such as liquid scintillation counting.
    Response. The regulatory text includes the phrase ``as appropriate 
for the use of the instrument.'' Therefore, if linearity or geometry 
tests are not appropriate for an instrument, the tests are not 
required.
    (2) Comment. Does the term ``unit dosage'' include a vial that 
contains multiple dosages?
    Response. A unit dosage can be either a pre-filled syringe or a 
vial that contains a prescribed dosage for a patient or a human 
research subject. Thus, a vial containing multiple dosages is not a 
unit dosage.
    (3) Comment. In some cases, it may not be practical to order an 
exact unit dosage before the administration to a patient or human 
research subject. For example, the size of a brain cyst is determined 
during surgery and a precise dosage cannot be prescribed before the 
operation.
    Response. In this example, an estimated unit dosage must first be 
ordered from the nuclear pharmacy. After the physician authorized user 
determines the precise dosage needed for the individual, the licensee 
may use either volume or weight to draw the precise dosage from the 
vial. The use of volume or weight for drawing a smaller dosage from a 
vial containing an estimated dosage is acceptable because that vial 
contains only the estimated dosage for one individual. Thus, even if an 
error is made, the maximum error would be limited to the estimated 
dosage.
    (4) Comment. When drawing a dosage from a vial containing multiple 
dosages, a licensee should be allowed to determine the dosage by using 
volume and a measurement relative to some standard.
    Response. Relative measurement of the alpha- or beta-activity of a 
radioactive drug could be inaccurate for a variety of reasons, 
including inconsistent placement of the vial in the instrument's 
chamber. Without specific details of the procedure for this relative 
measurement, the accuracy of the measurement is unknown. Therefore, the 
proposed method of using volume and a measurement relative to some 
standard cannot be generically accepted.
    However, if a medical use licensee would like to propose a specific 
set of procedures for a relative measurement of a particular isotope 
that would provide acceptable accuracy, the licensee may apply for a 
license amendment on a case-by-case basis.
Section 35.53  Measurement of Dosages of Unsealed Byproduct Material 
for Medical Use
    There were some comments concerning measurements of dosages. These 
comments and NRC's responses have been discussed under Sec. 35.52.
Section 35.100  Use of Unsealed Byproduct Material for Uptake, 
Dilution, and Excretion
    There were several comments concerning this section. These comments 
and the NRC's responses are discussed below.
    (1) Comment. The NRC should continue to permit medical use 
licensees to share a nuclear pharmacy without requiring a Part 32 
license.
    Response. See response to comment  (1) of section 32.72(a)(2).
    (2) Comment. Section 35.100 should be modified to allow a medical 
use licensee to obtain a radioactive drug only for research purposes 
from those Part 33 licensees who are authorized to manufacture and 
distribute radioactive drugs to be used only for research experiments.
    Response. The Commission currently permits a Part 33 licensee to 
distribute, on a limited basis, radioactive drugs to be used only for 
research experiments through license amendment approvals on a case-by-
case basis. As discussed in the response to comments on 10 CFR 
32.72(a)(2), Part 33 licensees seeking this authority must first obtain 
a license amendment and receive an authorization for limited 
distribution pursuant to Part 32. Therefore, it is not necessary to 
modify Sec. 35.100 because it will allow medical use licensees to 
receive radioactive drugs from a Part 33 licensee authorized for 
limited distribution.
Section 35.910  Training for Uptake, Dilution, and Excretion Studies
    Comment. One commenter stated that the proposed amendment to this 
section would impose severe restrictions on basic human research. The 
commenter further stated that researchers who desire approval to 
administer radioisotopes for one or two basic studies in humans and who 
are not preparing to become nuclear medicine physicians, will not meet 
these strict criteria.
    Response. Under the NRC's existing regulatory framework, 
administering byproduct material to a patient or a human research 
subject must be done by a physician authorized user or by an individual 
under the supervision of a physician authorized user. The use of the 
term ``patient or human research subject'' in this section is to 
clarify that, if a researcher intends to conduct basic studies using 
human subjects involving byproduct material, it is necessary to have a 
physician authorized user provide supervision so that the researcher 
may administer byproduct material to human research subjects. This is 
an existing regulatory position and it has not been changed by this 
rulemaking.
Section 35.930  Training for Therapeutic Use of Unsealed Byproduct 
Material
    Comment. One commenter stated that the certification by the 
American Osteopathic Board of Radiology (AOBR) should be recognized in 
all applicable sections in 10 CFR Part 35. Under the existing 
regulations, the Commission has recognized AOBR in Secs. 35.910, 
35.920, 35.940, 35.950, and 35.960, but not in Sec. 35.300.
    Response. Following receipt of this comment, the Commission 
requested additional information from AOBR concerning training and 
certification criteria for therapeutic use of unsealed byproduct 
material. After reviewing supporting documents provided by the AOBR, 
the Commission has determined that the certification of AOBR is 
equivalent to the certification of American Board of Radiology (ABR). 
Therefore, recognition of certification by AOBR has been added in 
Sec. 35.930 of this final rule for certification granted after 1984 
because all candidates certified by AOBR since 1984 will meet the NRC's 
training requirements.
Section 35.972  Recentness of Training
    Comment. There were several comments concerning whether the 
recentness of training should be 5 years as in the existing 
regulations, or 7 years as in the proposed rule. Some commenters 
favored 5 years and stated that the clinical practice changes rapidly, 
thus, 5 years is more appropriate. Other commenters supported 7 years 
and stated that 5 years would be burdensome and would not ensure 
superior training.
    Response. The training required in Part 35 concerns radiation 
safety principles and practices for the protection of public health and 
safety. These radiation safety principles and practices are not 
expected to change rapidly with time. Therefore, the Commission is 
adopting 7 years because this will not reduce the level of radiation 
protection provided to workers and the public but will reduce the 
regulatory burden imposed on licensees.
Section 35.980  Training for Authorized Nuclear Pharmacist
    There were several comments pertaining to this section. These 
comments and the NRC's responses are summarized below.
    (1) Comment. The requirement for a preceptor statement is 
unnecessary and is irrelevant to the mission of the NRC. Many fully 
qualified nuclear pharmacists would be excluded from being an 
authorized nuclear pharmacist by this administrative requirement.
    Response. The written certification from a preceptor is a necessary 
part of the training and experience criteria. Even though an individual 
has completed the required 700 hours of the structured educational 
program, it is still uncertain as to whether this individual is capable 
of independently operating a nuclear pharmacy. The preceptor's 
statement is needed to ensure that this individual has achieved the 
competency to do so.
    With respect to a nuclear pharmacist who is currently qualified to 
be an authorized nuclear pharmacist, a new section (Sec. 35.981) has 
been added to address this issue.
    (2) Comment. It appears that the proposed rule is leaning towards 
board certification as the only available avenue open to a nuclear 
pharmacist desiring to be recognized as an authorized nuclear 
pharmacist in the near future.
    Response. There are other available avenues for a qualified 
individual to be recognized as an authorized nuclear pharmacist. Other 
avenues include: (i) Meeting the training criteria and obtaining a 
preceptor statement from an authorized nuclear pharmacist; or (ii) 
Meeting the ``grandfathering'' provisions as specified in Sec. 35.981 
of this final rule.
    (3) Comment. Whether an individual is qualified as an authorized 
nuclear pharmacist should be based on education and training, not just 
based on BPS certification.
    Response. The Commission agrees that qualification as an authorized 
nuclear pharmacist should be based on training and experience. This 
final rule provides several ways, including BPS certification, to 
achieve authorized nuclear pharmacist status, all of which include a 
minimum level of training and experience. The various ways to achieve 
this status are provided in Secs. 35.980 and 35.981.
    (4) Comment. It is imperative that training programs be monitored 
by appropriate independent oversight processes (e.g., American Council 
on Pharmaceutical Education in the case of pharmacy).
    Response. The Commission agrees that it could be useful for a 
training program to be monitored by an independent oversight group. In 
addition, the Commission encourages voluntary oversight by an 
independent group such as a professional association. However, given 
the oversight roles of the preceptor and the Radiation Safety 
Committee, the Commission does not see a need to incorporate such a 
requirement.
    (5) Comment. If an authorized nuclear pharmacist decides not to 
seek recertification as a Board Certified Nuclear Pharmacist, would the 
individual lose the authorized nuclear pharmacist status?
    Response. See response to comment (3) of Sec. 32.72(b).
    (6) Comment. It appears that the NRC desires to make ``authorized 
nuclear pharmacist'' status available only to those pharmacists who are 
engaged in active clinical practice settings. This status should be 
also available to qualified nuclear pharmacists working in facilities 
other than clinical practice settings, such as in the research 
laboratories or academic settings.
    Response. An authorized nuclear pharmacist who meets the training 
requirements as specified in Sec. 35.980 should be competent to 
independently operate a nuclear pharmacy regardless of the setting. 
When there is a need for an authorized nuclear pharmacist outside the 
clinical setting, qualified individuals in research laboratories or 
academic settings may also be designated as authorized nuclear 
pharmacists.
    (7) Comment. Authorized nuclear pharmacist status should be 
available to those individuals who have practiced radiopharmacy for a 
long time but who are not licensed pharmacists.
    Response. The Commission believes that an individual should not 
practice pharmacy unless this individual is licensed as a pharmacist by 
a State. Thus, an authorized nuclear pharmacist must be a licensed 
pharmacist as required by Secs. 35.980 and 35.981. However, an 
experienced individual (e.g., a nuclear chemist) may continue to work 
in a nuclear pharmacy under the supervision of an authorized nuclear 
pharmacist or a physician authorized user.
    (8) Comment. The Florida State Board of Pharmacy issues nuclear 
pharmacists a separate license based on a review of the individual's 
qualification by its Nuclear Pharmacy Committee. Additionally, it 
requires a mandatory 12-hours per annum of continuing education in a 
specific range of topic areas pertinent to nuclear pharmacy practice. 
With this type of licensing review process already in place, how would 
the NRC consider applying this towards its ``limited grandfathering'' 
process for granting ``authorized nuclear pharmacist'' status to 
Florida nuclear pharmacists? Would the Commission consider this 
established Florida process for pharmacists as carrying sufficient 
weight which might serve as a third alternative to its proposed 
language in 10 CFR 35.980?
    Response. Section 35.980 specifies that a pharmacist could be 
qualified as an authorized nuclear pharmacist in two ways: (i) Through 
BPS certification; or (ii) through a structured educational program and 
a preceptor's statement. Because qualification as an authorized nuclear 
pharmacist depends primarily on training and experience, if Florida 
licensed nuclear pharmacists currently meet either (i) or (ii), they 
could qualify as authorized nuclear pharmacists. If they do not meet 
either (i) or (ii), they would need either more training or experience, 
or a preceptor's statement to qualify. Therefore, there is no benefit 
to adding a third alternative to 10 CFR 35.980.
    For ``grandfathering'' an experienced nuclear pharmacist, a new 
section (Sec. 35.981) has been added to the final rule. This section 
specifies that an experienced pharmacist will be given authorized 
nuclear pharmacist status if the individual:
    (i) Is a licensed pharmacist,
    (ii) Is currently working in a nuclear pharmacy, and
    (iii) Has completed a structured educational program as specified 
in Sec. 35.980(b)(1).
    A Florida licensed nuclear pharmacist who is currently working in a 
nuclear pharmacy could satisfy the first two criteria. However, the 
comment letter did not provide any information regarding whether this 
individual meets the third criterion. Therefore, such a nuclear 
pharmacist could qualify as an authorized nuclear pharmacist if that 
individual has completed a structured educational program that equals 
or exceeds the requirements of Sec. 35.980(b)(1).
Section 35.981  Training for Experienced Nuclear Pharmacists
    Comment. This section was not included in the proposed rule, but 
has been added to the final rule in response to numerous comments. The 
comments suggested that the NRC should provide a mechanism for 
``grandfathering'' qualified nuclear pharmacists who are currently 
working in hospital-based nuclear pharmacies, similar to the mechanism 
proposed for ``grandfathering'' qualified individuals who are currently 
working in commercial nuclear pharmacies.
    Response. The Commission agrees with these comments because the 
``grandfathering'' provisions should apply regardless of whether a 
qualified nuclear pharmacist is currently working in a commercial 
nuclear pharmacy or a hospital-based nuclear pharmacy. Therefore, this 
section has been added to the final rule.

III. Discussion of Final Rule Text

    This section discusses those provisions of the final rule in which 
the proposed rule language has been modified. These modifications are 
either based on public comments or the Commission's identified need to 
modify or clarify the rule language. Provisions in which the final rule 
language remains the same as the proposed rule language will not be 
discussed in this section. Referring to section V entitled ``Text of 
Final Regulations'' may expedite the reader's understanding of this 
discussion.

Section 32.72  Manufacture, Preparation, or Transfer for Commercial 
Distribution of Radioactive Drugs Containing Byproduct Material for 
Medical Use Under 10 CFR Part 35

Section 32.72(a)(4)
    This paragraph contains one modification of the proposed rule 
language. The phrase ``one label is acceptable to NRC provided that it 
contains all of the information which NRC requires'' has been added at 
the end of the last sentence of this paragraph. This phrase has been 
added to clarify that this rule allows licensees to use one label if 
that label contains all the information specified in this section.
Section 32.72(b)
    The proposed rule language has been modified to clarify the intent 
of this section. These modifications are discussed below.
    (1) The phrase ``a licensee described by paragraph (a)(2)(iii) or 
(iv) of this section'' has been moved from proposed Sec. 32.72(b)(1) to 
the introductory phrase of Sec. 32.72(b) to clarify that this phrase 
applies throughout paragraph (b).
    (2) The final rule text of Sec. 32.72(b)(1) is essentially the same 
as the proposed (b)(1) except that the reference to the definition of 
``authorized nuclear pharmacist'' in Part 35 has been moved to 
paragraph (b)(2).
    (3) A new Sec. 35.72(b)(2) has been added to the final rule to make 
clear that there are three different ways that an individual may 
qualify as an authorized nuclear pharmacist.
    (4) A new Sec. 35.72(b)(3) has been added to the final rule to make 
clear that the actions authorized in Sec. 32.72(b)(1) and (2) are 
permitted in spite of more restrictive language in existing license 
conditions and to avoid the need for many license amendments in order 
to implement the Commission's intentions.
    (5) The proposed Sec. 32.72(b)(2), which provided criteria for 
``grandfathering'' qualified Part 32 ``authorized users,'' has been 
redesignated as Sec. 32.72(b)(4). Also, the proposed rule specified 
that a pharmacist may be ``grandfathered'' if the individual is 
identified on a Commission license as an ``authorized user'' on or 
before the ``effective date'' of the rule; this cutoff date has been 
changed to the publication date of the final rule. This change is 
needed because the Commission believes that ``grandfathering'' is only 
appropriate for those qualified nuclear pharmacists who are 
``authorized users'' on or before the publication date of this final 
rule.
    (6) The proposed Sec. 32.72(b)(3), which requires licensees to 
provide certain documents, has been redesignated as Sec. 32.72(b)(5). 
The final rule text in this paragraph has been modified to include 
several editorial changes, including:
    (i) Replacing the phrase ``the individual's board certification, 
the license, or the permit'' by the phrase ``each individual's 
certification by the Board of Pharmaceutical Specialties, the 
Commission or Agreement State license, or the permit issued by a 
licensee of broad scope'';
    (ii) Replacing the phrase ``within 30 days of the date'' by the 
phrase ``no later than 30 days after the date''; and
    (iii) Adding ``pursuant to paragraphs (b)(2)(i) or (b)(2)(iii)'' to 
indicate that a notification is not required by paragraph (b)(2)(ii) 
because a license amendment is required.

Section 35.2  Definitions

    Authorized nuclear pharmacist. During the public comment period, 
the Commission became aware that the word ``currently'' is unnecessary 
in the proposed phrase ``Authorized nuclear pharmacist means a 
pharmacist who is: (1) Currently board certified as a nuclear 
pharmacist by ______.'' Therefore, the word, ``currently,'' has been 
removed in the final rule.
    Misadministration. During the public comment period, the Commission 
became aware of the need to clarify paragraph (4)(iii) of this 
definition. The existing rule language, ``When the calculated weekly 
administered dose is 30 percent greater than the weekly prescribed 
dose,'' if interpreted literally, means that a misadministration has 
occurred only when the calculated weekly administered dose is exactly 
30 percent greater than the weekly prescribed dose. The Commission 
intended for this definition to cover incidents in which there is a 
difference of 30 percent or more between the calculated weekly 
administered dose and the weekly prescribed dose. To ensure that there 
is no ambiguity as to the meaning of this provision, it has been 
reworded and the key phrase in the rule language has been changed from 
``30 percent greater than'' to ``30 percent or more.'' Because this 
better expresses the intent of the existing rule and is a minor 
administrative correction, the Commission believes that it can be 
incorporated in this final rule without having first been included in 
the proposed rule.
    Recordable event. The existing regulatory text of paragraph (5) of 
this definition of ``recordable event'' contains the same word 
structure as paragraph (4)(iii) of the definition of misadministration 
(discussed above). To ensure that there is no ambiguity as to the 
meaning of this provision, it has been reworded and the key phrase in 
the rule language has been changed from ``15 percent greater than'' to 
``15 percent or more.'' Because this better expresses the intent of the 
existing rule and is a minor administrative correction, the Commission 
believes that it can be incorporated in this final rule without having 
first been included in the proposed rule.
    Visiting authorized user. During the public comment period, the 
Commission became aware of the need to delete this definition. This 
definition is no longer necessary because Sec. 35.27, ``Visiting 
authorized user,'' in which this definition is applicable is being 
deleted. Therefore, this definition is being removed from the final 
rule.

Section 35.6  Provisions for Research Involving Human Subjects

    This section contains one modification of the proposed rule 
language. The phrase ``in accordance with the meaning of these terms as 
defined and described in the Federal Policy for the Protection of Human 
Subjects'' has been added at the end of the last sentence of this 
section. This phrase has been added to explicitly state that the terms 
``informed consent'' and ``IRB approval'' have the same meaning 
ascribed to those terms in the Federal Policy for the Protection of 
Human Subjects.

Section 35.11  License Required

    There is no change between the final rule language and the proposed 
rule language. However, licensees are reminded that if a licensee 
intends to increase its possession limit for any byproduct material 
isotope or add any new byproduct material isotopes, the licensee must 
first obtain a license amendment.

Section 35.13  License Amendments

    There is no change between the final rule language and the proposed 
rule language in this section. However, the purpose of this discussion 
is to remind medical use licensees who are not medical institutions 
that, pursuant to paragraphs (b)(1) through (b)(4) of this section, 
they must review the necessary credentials and approve or disapprove 
any individual who is to work as an authorized user or authorized 
nuclear pharmacist. In a medical institution, this review and approval 
must be performed by its Radiation Safety Committee (see 
Sec. 35.22(b)(2)(ii)).

Section 35.14  Notification

    This section contains two editorial changes: (1) the phrase 
``within 30 days of the date'' has been replaced by the phrase ``no 
later than 30 days after the date,'' and (2) the phrase ``the license, 
or the permit'' has been replaced by ``the Commission or Agreement 
state license, or the permit issued by a licensee of broad scope.''

Section 35.25  Supervision

    There is a modification to the proposed rule in this section. The 
proposed rule stated that the supervising authorized nuclear pharmacist 
or physician authorized user must instruct the workers. The final rule 
allows the instruction to be delegated to other qualified individuals. 
This change is based on public comments requesting that the instruction 
of workers be done by the supervising individuals as well as by other 
qualified individuals. However, the requirement for periodically 
reviewing the work of supervised individuals remains with the 
supervising authorized nuclear pharmacist or physician authorized user.

Section 35.50  Possession, Use, Calibration, and Checks of Dose 
Calibrators

    There is an editorial change in this section. The phrase in the 
proposed rule ``over the range of its use between ______ and ______'' 
has been replaced by ``over a range from ______ to ______.''

Section 35.900  Radiation Safety Officer

    Two additional board certifications have been recognized in this 
section of the final rule.
    During the public comment period, the Commission became aware of 
the need to recognize certifications by the American Osteopathic Board 
of Nuclear Medicine (AOBNM) and the American Osteopathic Board of 
Radiology (AOBR). A letter dated August 16, 1990, from Richard E. 
Cunningham (Director, Division of Industrial and Medical Nuclear 
Safety, NRC), to Paul J. Chase (Chairman, AOBR and Vice President, 
AOBNM), stated that the NRC intended to include certifications of (1) 
AOBR in Sec. 35.900, and (2) AOBNM in Secs. 35.900, 35.910, and 35.920 
in the next amendment to 10 CFR Part 35. Therefore, the certifications 
by AOBR and AOBNM have been added to this section of the final rule.

Section 35.910  Training for Uptake, Dilution, and Excretion Studies

Section 35.920  Training for Imaging and Localization Studies

    One additional board certification has been recognized in both 
sections of the final rule.
    As discussed in the previous section, the Commission became aware 
of the need to recognize certification by AOBNM. Therefore, the 
certification by AOBNM has been added to both sections of the final 
rule.

Section 35.930  Training for Therapeutic Use of Unsealed Byproduct 
Material

    Two additional board certifications have been recognized in this 
section of the final rule.
    A comment stated that certification by the American Osteopathic 
Board of Radiology (AOBR) should be recognized in all applicable 
sections of 10 CFR Part 35. Under the existing regulations, the 
Commission has recognized AOBR certification in Secs. 35.910, 35,920, 
35.940, 35.950, and 35.960.
    Following receipt of this comment, the Commission requested 
additional information from AOBR concerning training and certification 
criteria for therapeutic use of unsealed byproduct material. After 
reviewing supporting documents provided by the American Osteopathic 
College of Radiology (AOCR), the Commission has determined that AOBR 
certification is equivalent to certification by the American Board of 
Radiology (ABR). Therefore, recognition of certification by AOBR has 
been added in Sec. 35.930 of this final rule for certification granted 
after 1984 because all candidates certified by AOBR since 1984 will 
meet the NRC's training requirements.
    During the public comment period, the Commission also became aware 
of the need to recognize in Sec. 35.930 certification by the Royal 
College of Physicians and Surgeons of Canada. This is in addition to 
the recognition reflected in Secs. 35.900, 35.910, and 35.920 of the 
proposed rule. A letter dated June 3, 1992, from John E. Glenn (Chief, 
Medical, Academic and Commercial Use Safety Branch, Division of 
Industrial and Medical Nuclear Safety, NRC), to Gilles D. Hurteau of 
the Royal College of Physicians and Surgeons of Canada, stated that 
certification by the latter is acceptable for approval, among other 
things, as an authorized user in Sec. 35.300. Therefore, certification 
by the Royal College of Physicians and Surgeons of Canada has been 
added to this section of the final rule.

Section 35.981  Training for Experienced Nuclear Pharmacists

    This section was not included in the proposed rule, but has been 
added to the final rule in response to numerous comments. This section 
has been patterned after the provisions in 10 CFR Part 32 for 
``grandfathering'' an ``authorized user.''
    To ``grandfather'' an experienced nuclear pharmacist, the licensee 
needs to apply for a license amendment identifying that individual as 
an authorized nuclear pharmacist. The licensee must receive the license 
amendment before allowing that individual to work as an authorized 
nuclear pharmacist.
    A licensee seeking to ``grandfather'' a nuclear pharmacist must 
ensure that the individual has completed a structured educational 
program as specified in Sec. 35.980(b)(1) on or before (the date of 
publication in the Federal Register) and is currently working as a 
nuclear pharmacist. However, the individual does not need a preceptor 
statement (Sec. 35.980(b)(2)) and the individual's training, specified 
above, does not need to be within 7 years preceding the date of 
application (Sec. 35.972).

Agreement State Compatibility

    There were numerous public comments concerning compatibility. The 
commenters offered a wide range of opinions, from those recommending no 
compatibility to those favoring identical requirements between 
Agreement States and the NRC. These comments and NRC's responses will 
be discussed at the end of this section.
    After considering the comments, the Commission has determined that 
the compatibility levels for the final rule should remain the same as 
the proposed rule. All definitions contained in Secs. 30.4 and 35.2 
that are established or modified by this rulemaking are Division 1 
levels of compatibility. These definitions must be the same for all NRC 
and Agreement State licensees so that national consistency can be 
maintained.
    Additionally, Secs. 32.72, 35.6, 35.22(b)(2), 35.25, 35.50, 35.52, 
35.53, 35.920, 35.972, 35.980, and 35.981 are Division 2 levels of 
compatibility because requirements at least this stringent are 
necessary to ensure adequate protection of the public health and 
safety. The Agreement States will be allowed to establish requirements 
that are more stringent than the NRC's requirements, but not less 
stringent.
    It would be appropriate for Agreement States to adopt the remaining 
sections of these revisions to Part 35 in this rulemaking, but it is 
not necessary to require any degree of compatibility between NRC and 
the States. Therefore, a Division 3 level of compatibility is 
appropriate for these sections.
    The Commission is currently developing a new policy on Agreement 
State compatibility. This development will include involvement of the 
Agreement States and the general public. At the conclusion of this 
effort, the Commission will implement guidance on the application of 
adequacy and compatibility and in light of the new guidance will 
reassess the existing compatibility levels.
    The Commission expects Agreement States to adopt rules required to 
maintain compatibility within 3 years after NRC's rules become 
effective. However, the States may elect to implement on a temporary 
basis the requirements contained in this final rule through license 
conditions prior to promulgation of the rule necessary for 
compatibility. In the preamble of the notice of the proposed rule, the 
Commission stated that some Agreement States, faced with administrative 
and resource constraints, may find the 3-year time period difficult to 
attain and may prefer that NRC extend flexibility in such cases to 
allow the States to implement the requirements through license 
conditions. In the same notice, the Commission requested public comment 
on permitting Agreement States flexibility in this regard, and if 
permitted, under what conditions.
    The NRC did not receive any comments on implementing requirements 
through license conditions. Under current policy, the Agreement States 
have the flexibility to implement the requirements contained in this 
final rule on a temporary basis through license conditions, until they 
adopt compatible rules. In addition, this issue will be addressed in 
the development of a new policy statement on adequacy and 
compatibility.
    There were numerous comments related to Agreement State 
compatibility. These comments and the NRC's responses are summarized 
below.
    (1) Comment. It is inappropriate for the NRC to use the existing 
policy for compatibility determinations regarding this rulemaking 
because the NRC is currently considering a new policy.
    Response. The Commission must use the existing policy for 
compatibility determinations regarding all rulemakings until the new 
policy becomes effective. At that time, the Commission expects that the 
existing compatibility determinations will be reviewed in light of the 
new policy.
    (2) Comment. There is an increasing tendency of NRC to use the term 
``safety significance'' in justifying the NRC's position on 
compatibility determination. But the question is, ``How much 
significance?''
     Response. Under the existing policy the Commission considers the 
safety significance of a particular requirement, i.e., whether it is 
necessary to ensure adequate protection of the public health and 
safety, in determining whether it should be an item of Agreement State 
compatibility. If it is necessary to ensure adequate protection, the 
requirement will, at a minimum, be Division 2 level of compatibility. 
In addition, if the requirement is both necessary for adequate 
protection and clear communication, it will be a Division 1 level of 
compatibility. Using these criteria, the Commission has made the 
findings on compatibility described above. The basic objective of these 
findings is to ensure that the public receives adequate radiation 
protection during medical procedures without undue interference in the 
practices of pharmacy and medicine. The relationship between 
compatibility and health and safety will be clarified in the new policy 
on Agreement State compatibility.
    (3) Comment. Some commenters suggested that Agreement States' 
requirements should be identical to NRC's requirements. Other 
commenters suggested that a high degree of consistency between 
Agreement States and the NRC on medical rules is not necessary.
    Response. The Commission believes in some cases, that it is 
necessary for Agreement States' regulations to be essentially verbatim, 
i.e., identical, to NRC regulations. In other cases, it is necessary 
for the Agreement States to adopt the provisions in a consistent 
although not identical form. As discussed above in the response to 
comment (2), the Commission has determined which provisions of this 
rule are a Division 1 level of compatibility. Except for definitions 
which are a Division 1 level of compatibility, all other provisions of 
this final rule are either Division 2 or 3 levels of compatibility. 
Thus, for this final rule, uniformity is not required between Agreement 
States and the NRC for all provisions.
    (4) Comment. Medical facilities are essentially fixed facilities 
with little or no implications for interstate commerce. Where is the 
justification for the NRC's position?
    Response. In the proposed rule, the NRC did not state that the 
reason for the proposed compatibility levels was due to interstate 
commerce implications. As stated earlier, the justifications for 
compatibility are as follows. All definitions contained in Secs. 30.4 
and 35.2 that are established or modified by this rulemaking are 
Division 1 levels of compatibility. These definitions must be the same 
for all NRC and Agreement State licensees so that national consistency 
can be maintained. Also, certain specific sections are Division 2 
levels of compatibility because requirements at least this stringent 
are necessary to ensure adequate protection of the public health and 
safety.
    (5) Comment. The proposed rule stated that all definitions in 
Secs. 30.4 and 35.2 would be Division 1 levels of compatibility. This 
would include definitions in Sec. 30.4 that do not relate to medical 
uses and should not be affected by this rulemaking.
    Response. The language in the preamble for the proposed rule 
intended to indicate that all definitions in Secs. 30.4 and 35.2 that 
are established or modified by this rulemaking would be Division 1 
levels of compatibility. Levels of compatibility for other definitions 
in existing Secs. 30.4 and 35.2 that are not modified in this 
rulemaking will remain unchanged. The language in this preamble has 
been modified to clarify this point.
    (6) Comment. Based on the State Agreements Program Procedure B.7, 
all Part 35 items categorized in that procedure are Division 3.
    Response. Before the quality management program and 
misadministration rulemaking became effective, all sections in Part 35 
were Division 3 levels of compatibility. However, following that 
amendment (56 FR 34104; July 25, 1991), the levels of compatibility for 
Part 35 were modified as follows: The definitions associated with the 
quality management rule and misadministrations in Sec. 35.2 became 
Division 1 levels of compatibility; Secs. 35.32 and 35.33 became 
Division 2 levels of compatibility; Sec. 35.8 became a Division 4 level 
of compatibility; and all other sections of Part 35 remained Division 3 
levels of compatibility.
    (7) Comment. The proposed rule stated that Agreement States are 
expected to adopt rules required to maintain compatibility within 3 
years. Agreement States should be able to adopt this rulemaking in a 
shorter time.
    Response. Some Agreement States may need less time to adopt certain 
parts of this rulemaking. Other Agreement States may need the full 3 
years to adopt the rule because of constraints on resources. Therefore, 
the Commission retains the 3-year period for adopting this rule. In 
reevaluating its compatibility policy, the Commission is considering 
whether the time can be shortened when demonstrable health and safety 
considerations require it.
    (8) Comment. What would happen if an Agreement State fails to adopt 
requirements that are items of compatibility?
    Response. During the periodic review of the Agreement State's 
program, the NRC would determine whether the State meets the 
compatibility requirements. If not, the State would be notified that 
its program must be compatible with the NRC's requirements, and using 
current procedures a finding of compatibility for the Agreement State 
program would be withheld. Such a failure, if uncorrected or 
unjustified, could lead to the loss of the State's status as an 
Agreement State.
    (9) Comment. Creating a Division 1 or Division 2 level of 
compatibility for parts of this rule may cause conflict with State 
boards of pharmacy and medicine.
    Response. The provisions contained in this rulemaking that require 
a Division 1 or Division 2 level of compatibility are necessary to 
provide an adequate level of protection of public health and safety 
from radiological hazards. In addition, the Commission is not aware of 
any conflicts between these provisions and the requirements of State 
boards of pharmacy and medicine.

IV. Administrative Statements

Finding of No Significant Environmental Impact: Availability

    The Commission has determined under the National Environmental 
Policy Act of 1969, as amended, and the Commission's regulations in 
Subpart A of 10 CFR Part 51, that this final amendment is not a major 
Federal action significantly affecting the quality of the human 
environment, and therefore an environmental impact statement is not 
required. The final amendment provides greater flexibility for 
physician authorized users to use byproduct material in the practice of 
medicine. The final amendment will also incorporate into the 
regulations the concept of authorized nuclear pharmacists to permit 
properly qualified pharmacists to prepare radioactive drugs containing 
byproduct material in the practice of pharmacy.
    The final rule will allow physician authorized users greater 
discretion to prepare and use radioactive drugs containing byproduct 
material. The final rule will also allow authorized nuclear pharmacists 
greater discretion to prepare radioactive drugs containing byproduct 
material. It is expected that there will be no increase in radiation 
exposure to the public or to the environment beyond the exposures 
currently resulting from delivering the byproduct material or radiation 
from byproduct material to patients or human research subjects. The 
environmental assessment and finding of no significant impact on which 
this determination is based is available for inspection at the NRC 
Public Document Room, 2120 L Street NW. (Lower Level), Washington, DC. 
Single copies of the environmental assessment and the finding of no 
significant impact are available from Anthony N. Tse (see FOR FURTHER 
INFORMATION CONTACT heading).

Paperwork Reduction Act Statement

    This final rule amends information collection requirements that are 
subject to the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq). 
These requirements were approved by the Office of Management and 
Budget, approval numbers 3150-0001 and 3150-0010 for amendments to 10 
CFR Parts 32 and 35, respectively.
    The reduction in public burden for this collection of information 
is estimated to be a savings of 408 hours per year for 300 NRC 
licensees, or an average 1.4 hours per year per licensee, including the 
time for reviewing instructions, searching existing data sources, 
gathering and maintaining the data needed, and completing and reviewing 
the collection of information. Send comments regarding this burden 
estimate or any other aspect of this collection of information, 
including suggestions for reducing this burden, to the Information and 
Records Management Branch (T-6 F33), U.S. Nuclear Regulatory 
Commission, Washington, DC 20555, and to the Desk Officer, Office of 
Information and Regulatory Affairs, NEOB-10202, (3150-0001, -0010, and 
-0120), Office of Management and Budget, Washington, DC 20503.

Regulatory Analysis

    The Commission has prepared a final regulatory analysis on this 
regulation. The analysis examines the benefits and impacts considered 
by the Commission. No public comments were received on the draft 
regulatory analysis associated with the proposed rule. The final 
regulatory analysis is available for inspection at the NRC Public 
Document Room at 2120 L Street NW. (Lower Level), Washington, DC. 
Single copies of the draft analysis are available from Anthony N. Tse 
(see FOR FURTHER INFORMATION CONTACT heading).

Regulatory Flexibility Certification

    As required by the Regulatory Flexibility Act of 1980, 5 U.S.C. 
605(b), the Commission certifies that this rule will not have a 
significant economic impact on a substantial number of small entities. 
This rule affects medical use licensees including some private practice 
physicians. Some of these licensees would be considered small entities 
under the NRC's size standards (56 FR 56671; November 6, 1991). The 
amendments provide greater discretion for physician authorized users to 
use byproduct material in the practice of medicine. The amendments will 
also incorporate into the regulations the concept of authorized nuclear 
pharmacists to allow properly qualified pharmacists greater discretion 
to prepare (including compound) radioactive drugs containing byproduct 
material for medical use. This rule is expected to reduce regulatory 
burdens on medical use licensees, including small entities. No public 
comments were received related to the regulatory flexibility 
certification associated with the proposed rule.

Backfit Analysis

    The Commission has determined that the backfit rule, 10 CFR 50.109, 
does not apply to this amendment because this amendment does not 
involve any provisions which would impose backfits as defined in 10 CFR 
50.109(a)(1). Therefore, a backfit analysis is not required for this 
amendment.

List of Subjects

10 CFR Part 30

    Byproduct material, Criminal penalties, Government contracts, 
Intergovernmental relations, Isotopes, Nuclear materials, Radiation 
protection, Reporting and recordkeeping requirements.

10 CFR Part 32

    Byproduct material, Criminal Penalties, Labeling, Nuclear 
materials, Radiation protection, Reporting and recordkeeping 
requirements.

10 CFR Part 35

    Byproduct material, Criminal penalties, Drugs, Health facilities, 
Health professions, Medical devices, Nuclear materials, Occupational 
safety and health, Radiation protection, Reporting and recordkeeping 
requirements.

    For the reasons set out in the preamble and under the authority of 
the Atomic Energy Act of 1954, as amended, the Energy Reorganization 
Act of 1974, as amended, and 5 U.S.C. 552 and 553, the Commission is 
adopting the following amendments to 10 CFR Parts 30, 32, and 35.

V. Text of Final Regulations

PART 30--RULES OF GENERAL APPLICABILITY TO DOMESTIC LICENSING OF 
BYPRODUCT MATERIAL

    1. The authority citation for Part 30 continues to read as follows:

    Authority: Secs. 81, 82, 161, 182, 183, 186, 68 Stat. 935, 948, 
953, 954, 955, as amended, sec. 234, 83 Stat. 444, as amended (42 
U.S.C. 2111, 2112, 2201, 2232, 2233, 2236, 2282); secs. 201, as 
amended, 202, 206, 88 Stat. 1242, as amended, 1244, 1246 (42 U.S.C. 
5841, 5842, 5846).
    Section 30.7 also issued under Pub. L. 95-601, sec. 10, 92 Stat. 
2951 as amended by Pub. L. 102-486, Sec. 2902, 106 Stat. 3123, (42 
U.S.C. 5851). Section 30.34(b) also issued under sec. 184, 68 Stat. 
954, as amended (42 U.S.C. 2234). Section 30.61 also issued under 
sec. 187, 68 Stat. 955 (42 U.S.C. 2237).

    2. In Sec. 30.4, the definition of medical use is revised to read 
as follows:


Sec. 30.4  Definitions.

* * * * *
    Medical use means the intentional internal or external 
administration of byproduct material or the radiation therefrom to 
patients or human research subjects under the supervision of an 
authorized user as defined in 10 CFR Part 35.
* * * * *
    3. In Sec. 30.8, paragraphs (b) and (c) are revised to read as 
follows:


Sec. 30.8  Information collection requirements: OMB approval.

* * * * *
    (b) The approved information collection requirements contained in 
this part appear in Secs. 30.9, 30.11, 30.15, 30.19, 30.20, 30.32, 
30.34, 30.35, 30.36, 30.37, 30.38, 30.41, 30.50, 30.51, 30.55, and 
Appendix A.
    (c) This part contains information collection requirements in 
addition to those approved under the control number specified in 
paragraph (a) of this section. These information collection 
requirements and the control numbers under which they are approved are 
as follows:
    (1) In Secs. 30.32, 30.37, and 30.38, NRC Form 313 is approved 
under control number 3150-0120.
    (2) In Sec. 30.36, NRC Form 314 is approved under control number 
3150-0028.


Sec. 30.34  [Amended]

    4. Section 30.34 is amended by removing paragraph (i) in its 
entirety.

PART 32--SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER 
CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL

    5. The authority citation for Part 32 continues to read as follows:

    Authority: Secs. 81, 161, 182, 183, 68 Stat. 935, 948, 953, 954, 
as amended (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201, 88 Stat. 
1242, as amended (42 U.S.C. 5841).

    6. In Sec. 32.8, paragraphs (b) and (c) are revised to read as 
follows:


Sec. 32.8  Information collection requirements: OMB approval.

* * * * *
    (b) The approved information collection requirements contained in 
this part appear in Secs. 32.12, 32.14, 32.15, 32.16, 32.17, 32.18, 
32.19, 32.20, 32.22, 32.23, 32.25, 32.26, 32.27, 32.29, 32.51, 32.51a, 
32.52, 32.53, 32.54, 32.55, 32.56, 32.57, 32.58, 32.61, 32.62, 32.70, 
32.71, 32.72, and 32.74.
    (c) This part contains information collection requirements in 
addition to those approved under the control number specified in 
paragraph (a) of this section. These information collection 
requirements and the control numbers under which they are approved are 
as follows:
    (1) In Sec. 32.11, NRC Form 313 is approved under control number 
3150-0120.
    7. Section 32.72 is revised to read as follows:


Sec. 32.72  Manufacture, preparation, or transfer for commercial 
distribution of radioactive drugs containing byproduct material for 
medical use under Part 35.

    (a) An application for a specific license to manufacture, prepare, 
or transfer for commercial distribution radioactive drugs containing 
byproduct material for use by persons authorized pursuant to Part 35 of 
this chapter will be approved if:
    (1) The applicant satisfies the general requirements specified in 
10 CFR 30.33;
    (2) The applicant submits evidence that the applicant is at least 
one of the following:
    (i) Registered or licensed with the U.S. Food and Drug 
Administration (FDA) as a drug manufacturer;
    (ii) Registered or licensed with a state agency as a drug 
manufacturer;
    (iii) Licensed as a pharmacy by a State Board of Pharmacy; or
    (iv) Operating as a nuclear pharmacy within a Federal medical 
institution.
    (3) The applicant submits information on the radionuclide; the 
chemical and physical form; the maximum activity per vial, syringe, 
generator, or other container of the radioactive drug; and the 
shielding provided by the packaging to show it is appropriate for the 
safe handling and storage of the radioactive drugs by medical use 
licensees; and
    (4) A label is affixed to each container of a radioactive drug to 
be transferred for commercial distribution. The label must include the 
name of the radioactive drug or its abbreviation, quantity of 
radioactivity, and date and time of assay. For radioactive drugs with a 
half life greater than 100 days the time of assay may be omitted. In 
addition, the label for the syringe or syringe radiation shield must 
also contain the clinical procedure to be performed or the patient's or 
the human research subject's name. Furthermore, the label, or the 
leaflet or brochure that accompanies the radioactive drug, must contain 
a statement that the U.S. Nuclear Regulatory Commission has approved 
distribution of the byproduct material to persons licensed to use 
byproduct material pursuant to 10 CFR 35.100, 35.200, or 35.300, as 
appropriate, and to persons who hold an equivalent license issued by an 
Agreement State. The Commission's labeling requirements are independent 
of requirements of the U.S. Food and Drug Administration (FDA); one 
label is acceptable to NRC provided that it contains all of the 
information which NRC requires.
    (b) A licensee described by paragraph (a)(2)(iii) or (iv) of this 
section:
    (1) May prepare radioactive drugs for medical use, as defined in 10 
CFR 35.2, provided that the radioactive drug is prepared by either an 
authorized nuclear pharmacist, as specified in paragraph (b)(2) and 
(b)(3) of this section, or an individual under the supervision of an 
authorized nuclear pharmacist as specified in 10 CFR 35.25.
    (2) May allow a pharmacist to work as an authorized nuclear 
pharmacist if:
    (i) This individual qualifies as an authorized nuclear pharmacist 
as defined in 10 CFR 35.2,
    (ii) This individual meets the requirements specified in 10 CFR 
35.980(b) and 35.972 and the licensee has received an approved license 
amendment identifying this individual as an authorized nuclear 
pharmacist, or
    (iii) This individual is designated as an authorized nuclear 
pharmacist in accordance with paragraph (b)(3) of this section.
    (3) The actions authorized in paragraphs (b)(1) and (b)(2) of this 
section are permitted in spite of more restrictive language in license 
conditions.
    (4) May designate a pharmacist (as defined in 10 CFR 35.2) as an 
authorized nuclear pharmacist if the individual is identified as of 
(the date of publication in the Federal Register) as an ``authorized 
user'' on a nuclear pharmacy license issued by the Commission under 
this part.
    (5) Shall provide to the Commission a copy of each individual's 
certification by the Board of Pharmaceutical Specialties, the 
Commission or Agreement State license, or the permit issued by a 
licensee of broad scope, and a copy of the state pharmacy licensure or 
registration, no later than 30 days after the date that the licensee 
allows, pursuant to paragraphs (b)(2)(i) and (b)(2)(iii) of this 
section, the individual to work as an authorized nuclear pharmacist.
    (c) A licensee shall possess and use instrumentation to measure the 
radioactivity of radioactive drugs. The licensee shall have procedures 
for use of the instrumentation. The licensee shall 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. In 
addition, the licensee shall:
    (1) Perform tests before initial use, periodically, and following 
repair, on each instrument for accuracy, linearity, and geometry 
dependence, as appropriate for the use of the instrument; and make 
adjustments when necessary; and
    (2) Check each instrument for constancy and proper operation at the 
beginning of each day of use.
    (d) Nothing in this section relieves the licensee from complying 
with applicable FDA, other Federal, and State requirements governing 
radioactive drugs.


Sec. 32.73   [Removed]

    8. Section 32.73 is removed.
    9. In Sec. 32.303, paragraph (b) is revised to read as follows:


Sec. 32.303   Criminal penalties.

* * * * *
    (b) The regulations in Part 32 that are not issued under 
subsections 161b, 161i, or 161o for the purposes of section 223 are as 
follows: Secs. 32.1, 32.2, 32.8, 32.11, 32.14, 32.17, 32.18, 32.22, 
32.23, 32.24, 32.26, 32.27, 32.28, 32.51, 32.53, 32.57, 32.61, 32.71, 
32.74, 32.301, and 32.303.

PART 35--MEDICAL USE OF BYPRODUCT MATERIAL

    10. The authority citation for Part 35 continues to read as 
follows:

    Authority: Secs. 81, 161, 182, 183, 68 Stat. 935, 948, 953, 954, 
as amended (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201, 88 Stat. 
1242, as amended (42 U.S.C. 5841).

    11. In Sec. 35.2, the definition of visiting authorized user is 
removed; the definitions of authorized nuclear pharmacist and 
pharmacist are added; and the definitions of authorized user, medical 
use, misadministration--paragraphs (1)(i), (2)(i), (3)(i), (4)(i), 
(4)(iii), (5)(i), (6)(i), and (6)(ii), recordable event--paragraph (5), 
and written directive--the introductory text, are revised to read as 
follows:


Sec. 35.2   Definitions.

* * * * *
    Authorized nuclear pharmacist means a pharmacist who is:
    (1) Board certified as a nuclear pharmacist by the Board of 
Pharmaceutical Specialties;
    (2) Identified as an authorized nuclear pharmacist on a Commission 
or Agreement State license that authorizes the use of byproduct 
material in the practice of nuclear pharmacy; or
    (3) Identified as an authorized nuclear pharmacist on a permit 
issued by a Commission or Agreement State specific licensee of broad 
scope that is authorized to permit the use of byproduct material in the 
practice of nuclear pharmacy.
    Authorized user means a physician, dentist, or podiatrist who is:
    (1) Board certified by at least one of the boards listed in 
Paragraph (a) of Secs. 35.910, 35.920, 35.930, 35.940, 35.950, or 
35.960;
    (2) Identified as an authorized user on a Commission or Agreement 
State license that authorizes the medical use of byproduct material; or
    (3) Identified as an authorized user on a permit issued by a 
Commission or Agreement State specific licensee of broad scope that is 
authorized to permit the medical use of byproduct material.
* * * * *
    Medical use means the intentional internal or external 
administration of byproduct material or the radiation therefrom to 
patients or human research subjects under the supervision of an 
authorized user.
* * * * *
    Misadministration means the administration of:
    (1) * * *
    (i) Involving the wrong patient or human research subject, or wrong 
radiopharmaceutical; or
* * * * *
    (2) * * *
    (i) Involving the wrong patient or human research subject, wrong 
radiopharmaceutical, or wrong route of administration; or
* * * * *
    (3) * * *
    (i) Involving the wrong patient or human research subject, or wrong 
treatment site; or
* * * * *
    (4) * * *
    (i) Involving the wrong patient or human research subject, wrong 
mode of treatment, or wrong treatment site;
* * * * *
    (iii) When the calculated weekly administered dose exceeds the 
weekly prescribed dose by 30 percent or more of the weekly prescribed 
dose; or
* * * * *
    (5) * * *
    (i) Involving the wrong patient or human research subject, wrong 
radioisotope, or wrong treatment site (excluding, for permanent 
implants, seeds that were implanted in the correct site but migrated 
outside the treatment site);
* * * * *
    (6) * * *
    (i) Involving the wrong patient or human research subject, wrong 
radiopharmaceutical, wrong route of administration, or when the 
administered dosage differs from the prescribed dosage; and
    (ii) When the dose to the patient or human research subject exceeds 
5 rems effective dose equivalent or 50 rems dose equivalent to any 
individual organ.
* * * * *
    Pharmacist means an individual licensed by a State or Territory of 
the United States, the District of Columbia, or the Commonwealth of 
Puerto Rico to practice pharmacy.
* * * * *
    Recordable event means the administration of:
* * * * *
    (5) A teletherapy radiation dose when the calculated weekly 
administered dose exceeds the weekly prescribed dose by 15 percent or 
more of the weekly prescribed dose; or
* * * * *
    Written directive means an order in writing for a specific patient 
or human research subject, dated and signed by an authorized user prior 
to the administration of a radiopharmaceutical or radiation, except as 
specified in paragraph (6) of this definition, containing the following 
information:
* * * * *
    12. Section 35.6 is added to read as follows:


Sec. 35.6  Provisions for research involving human subjects.

    A licensee may conduct research involving human subjects using 
byproduct material provided that the research is conducted, funded, 
supported, or regulated by another Federal Agency which has implemented 
the Federal Policy for the Protection of Human Subjects. Otherwise, a 
licensee shall apply for and receive approval of a specific amendment 
to its NRC license before conducting such research. Both types of 
licensees shall, at a minimum, obtain informed consent from the human 
subjects and obtain prior review and approval of the research 
activities by an ``Institutional Review Board'' in accordance with the 
meaning of these terms as defined and described in the Federal Policy 
for the Protection of Human Subjects.
    13. Section 35.7 is added to read as follows:


Sec. 35.7  FDA, other Federal, and State requirements.

    Nothing in this part relieves the licensee from complying with 
applicable FDA, other Federal, and State requirements governing 
radioactive drugs or devices.
    14. In Sec. 35.8, paragraph (b) is revised to read as follows:


Sec. 35.8  Information collection requirements: OMB approval.

* * * * *
    (b) The approved information collection requirements contained in 
this part appear in Secs. 35.6, 35.12, 35.13, 35.14, 35.21, 35.22, 
35.23, 35.29, 35.31, 35.50, 35.51, 35.52, 35.53, 35.59, 35.60, 35.61, 
35.70, 35.80, 35.92, 35.204, 35.205, 35.310, 35.315, 35.404, 35.406, 
35.410, 35.415, 35.606, 35.610, 35.615, 35.630, 35.632, 35.634, 35.636, 
35.641, 35.643, 35.645, 35.647, 35.980, and 35.981.
* * * * *
    15. In Sec. 35.11, paragraph (a) is revised and paragraph (c) is 
added to read as follows:


Sec. 35.11  License required.

    (a) A person shall not manufacture, produce, acquire, receive, 
possess, use, or transfer byproduct material for medical use except 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.
* * * * *
    (c) An individual may prepare 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 Sec. 35.25, unless prohibited by license condition.
    16. In Sec. 35.12, paragraph (e) is added to read as follows:


Sec. 35.12  Application for license, amendment, or renewal.

* * * * *
    (e) An applicant that satisfies the requirements specified in 10 
CFR 33.13 may apply for a Type A specific license of broad scope.
    17. In Sec. 35.13, paragraph (b) is revised to read as follows:


Sec. 35.13  License amendments.

* * * * *
    (b) Before it permits anyone to work as an authorized user or 
authorized nuclear pharmacist under the license, except an individual 
who is:
    (1) An authorized user certified by the organizations specified in 
paragraph (a) of Sec. 35.910, 35.920, 35.930, 35.940, 35.950, or 
35.960;
    (2) An authorized nuclear pharmacist certified by the organization 
specified in paragraph (a) of Sec. 35.980;
    (3) Identified as an authorized user or an authorized nuclear 
pharmacist on a Commission or Agreement State license that authorizes 
the use of byproduct material in medical use or in the practice of 
nuclear pharmacy, respectively; or
    (4) Identified as an authorized user or an authorized nuclear 
pharmacist on a permit issued by a Commission or Agreement State 
specific licensee of broad scope that is authorized to permit the use 
of byproduct material in medical use or in the practice of nuclear 
pharmacy, respectively.
* * * * *
    18. Section 35.14 is revised to read as follows:


Sec. 35.14  Notifications.

    (a) A licensee shall provide to the Commission a copy of the board 
certification, the Commission or Agreement State license, or the permit 
issued by a licensee of broad scope for each individual no later than 
30 days after the date that the licensee permits the individual to work 
as an authorized user or an authorized nuclear pharmacist pursuant to 
Sec. 35.13 (b)(1) through (b)(4).
    (b) A licensee shall notify the Commission by letter no later than 
30 days after:
    (1) An authorized user, an authorized nuclear pharmacist, Radiation 
Safety Officer, or teletherapy physicist permanently discontinues 
performance of duties under the license or has a name change; or
    (2) The licensee's mailing address changes.
    (c) The licensee shall mail the documents required in this section 
to the appropriate address identified in Sec. 30.6 of this chapter.
    19. Section 35.15 is added to read as follows:


Sec. 35.15  Exemptions regarding Type A specific licenses of broad 
scope.

    A licensee possessing a Type A specific license of broad scope for 
medical use is exempt from the following:
    (a) The provisions of Sec. 35.13(b);
    (b) The provisions of Sec. 35.13(e) regarding additions to or 
changes in the areas of use only at the addresses specified in the 
license;
    (c) The provisions of Sec. 35.14(a); and
    (d) The provisions of Sec. 35.14(b)(1) for an authorized user or an 
authorized nuclear pharmacist.
    20. In Sec. 35.22, paragraph (b)(2) is revised to read as follows:


Sec. 35.22  Radiation Safety Committee.

* * * * *
    (b) * * *
    (2)(i) Review, on the basis of safety and with regard to the 
training and experience standards in Subpart J of this part, and 
approve or disapprove any individual who is to be listed as an 
authorized user, an authorized nuclear pharmacist, the Radiation Safety 
Officer, or a teletherapy physicist before submitting a license 
application or request for amendment or renewal; or
    (ii) Review, pursuant to Sec. 35.13 (b)(1) through (b)(4), on the 
basis of the board certification, the license, or the permit 
identifying an individual, and approve or disapprove any individual 
prior to allowing that individual to work as an authorized user or 
authorized nuclear pharmacist;
* * * * *
    21. In Sec. 35.25, paragraph (b) is redesignated as paragraph (c) 
and a new paragraph (b) is added to read as follows.


Sec. 35.25  Supervision.

* * * * *
    (b) A licensee that permits the preparation of byproduct material 
for medical use by an individual under the supervision of an authorized 
nuclear pharmacist or physician who is an authorized user, as allowed 
by Sec. 35.11(c), shall:
    (1) Instruct the supervised individual in the preparation of 
byproduct material for medical use and the principles of and procedures 
for radiation safety and in the licensee's written quality management 
program, as appropriate to that individual's use of byproduct material;
    (2) Require the supervised individual to follow the instructions 
given pursuant to paragraph (b)(1) of this section and to comply with 
the regulations of this chapter and license conditions; and
    (3) Require the supervising authorized nuclear pharmacist or 
physician who is an authorized user to periodically review the work of 
the supervised individual as it pertains to preparing byproduct 
material for medical use and the records kept to reflect that work.
* * * * *


Sec. 35.27  [Removed]

    22. Section 35.27 is removed.
    23. In Sec. 35.32, paragraphs (a)(2) and (b)(1)(i) are revised to 
read as follows:


Sec. 35.32  Quality management program.

    (a) * * *
    (2) That, prior to each administration, the patient's or human 
research subject's identity is verified by more than one method as the 
individual named in the written directive;
* * * * *
    (b) * * *
    (1) * * *
    (i) A representative sample of patient and human research subject 
administrations,
* * * * *
    24. In Sec. 35.33, paragraphs (a)(2), (a)(3), (a)(4), (b), and (c) 
are revised to read as follows:


Sec. 35.33  Notifications, reports, and records of misadministrations.

    (a) * * *
    (2) The licensee shall submit a written report to the appropriate 
NRC Regional Office listed in 10 CFR 30.6 within 15 days after 
discovery of the misadministration. The written report must include the 
licensee's name; the prescribing physician's name; a brief description 
of the event; why the event occurred; the effect on the patient or the 
human research subject; what improvements are needed to prevent 
recurrence; actions taken to prevent recurrence; whether the licensee 
notified the patient or the human research subject or the patient's or 
the human research subject's responsible relative or guardian (this 
individual will subsequently be referred to as ``the patient or human 
research subject''), and if not, why not, and if the patient or the 
human research subject was notified, what information was provided to 
that individual. The report must not include the patient's or the human 
research subject's name or other information that could lead to 
identification of the patient or the human research subject.
    (3) The licensee shall notify the referring physician and also 
notify the patient or the human research subject of the 
misadministration no later than 24 hours after its discovery, unless 
the referring physician personally informs the licensee either that he 
will inform the patient or the human research subject or that, based on 
medical judgment, telling the patient or the human research subject 
would be harmful to the patient or the human research subject. The 
licensee is not required to notify the patient or the human research 
subject without first consulting the referring physician. If the 
referring physician or the patient or the human research subject cannot 
be reached within 24 hours, the licensee shall notify the patient or 
the human research subject as soon as possible thereafter. The licensee 
may not delay any appropriate medical care for the patient or the human 
research subject, including any necessary remedial care as a result of 
the misadministration, because of any delay in notification.
    (4) If the patient or the human research subject was notified, the 
licensee shall also furnish, within 15 days after discovery of the 
misadministration, a written report to the patient or the human 
research subject by sending either:
    (i) A copy of the report that was submitted to the NRC; or
    (ii) A brief description of both the event and the consequences as 
they may affect the patient or the human research subject, provided a 
statement is included that the report submitted to the NRC can be 
obtained from the licensee.
    (b) Each licensee shall retain a record of each misadministration 
for five years. The record must contain the names of all individuals 
involved (including the prescribing physician, allied health personnel, 
the patient or the human research subject, and the patient's or human 
research subject's referring physician), the patient's or the human 
research subject's social security number or identification number if 
one has been assigned, a brief description of the misadministration, 
why it occurred, the effect on the patient or the human research 
subject, what improvements are needed to prevent recurrence, and the 
actions taken to prevent recurrence.
    (c) Aside from the notification requirement, nothing in this 
section affects any rights or duties of licensees and physicians in 
relation to each other, patients, or human research subjects (or the 
patient's or the human research subject's responsible relative or 
guardian).
    25. Section 35.49 is revised to read as follows:


Sec. 35.49  Suppliers for sealed sources or devices for medical use.

    A licensee may use for medical use only:
    (a) Sealed sources or devices manufactured, labeled, packaged, and 
distributed in accordance with a license issued pursuant to 10 CFR Part 
30 and 10 CFR 32.74 or the equivalent requirements of an Agreement 
State; or
    (b) Teletherapy sources manufactured and distributed in accordance 
with a license issued pursuant to 10 CFR Part 30 or the equivalent 
requirements of an Agreement State.
    26. In Sec. 35.50, paragraphs (a), (b)(3), and (e)(2) through 
(e)(4) are revised to read as follows:


Sec. 35.50  Possession, use, calibration, and check of dose 
calibrators.

    (a) A licensee shall possess and use a dose calibrator to measure 
the activity of dosages of photon-emitting radionuclides prior to 
administration to each patient or human research subject.
    (b) * * *
    (3) Test each dose calibrator for linearity upon installation and 
at least quarterly thereafter over a range from the highest dosage that 
will be administered to a patient or human research subject to 1.1 
megabecquerels (30 microcuries); and
* * * * *
    (e) * * *
    (2) For paragraph (b)(2) of this section, the model and serial 
number of the dose calibrator, the model and serial number of each 
source used, the identity of the radionuclide contained in the source 
and its activity, the date of the test, the results of the test, and 
the identity of the individual performing the test.
    (3) For paragraph (b)(3) of this section, the model and serial 
number of the dose calibrator, the calculated activities, the measured 
activities, the date of the test, and the identity of the individual 
performing the test.
    (4) For paragraph (b)(4) of this section, the model and serial 
number of the dose calibrator, the configuration of the source 
measured, the activity measured for each volume measured, the date of 
the test, and the identity of the individual performing the test.
    27. Section 35.52 is added to read as follows:


Sec. 35.52  Possession, use, calibration, and check of instruments to 
measure dosages of alpha- or beta-emitting radionuclides.

    (a) This section does not apply to unit dosages of alpha- or beta- 
emitting radionuclides that are obtained from a manufacturer or 
preparer licensed pursuant to 10 CFR 32.72 or equivalent Agreement 
State requirements.
    (b) For other than unit dosages obtained pursuant to paragraph (a) 
of this section, a licensee shall possess and use instrumentation to 
measure the radioactivity of alpha- or beta-emitting radionuclides. The 
licensee shall have procedures for use of the instrumentation. The 
licensee shall measure, by direct measurement or by combination of 
measurements and calculations, the amount of radioactivity in dosages 
of alpha- or beta-emitting radionuclides prior to administration to 
each patient or human research subject. In addition, the licensee 
shall:
    (1) Perform tests before initial use, periodically, and following 
repair, on each instrument for accuracy, linearity, and geometry 
dependence, as appropriate for the use of the instrument; and make 
adjustments when necessary; and
    (2) Check each instrument for constancy and proper operation at the 
beginning of each day of use.
    28. In Sec. 35.53, the section heading and paragraphs (a), (b), 
(c)(2), and (c)(3) are revised as follows:


Sec. 35.53  Measurement of dosages of unsealed byproduct material for 
medical use.

* * * * *
    (a) Measure the activity of each dosage of a photon-emitting 
radionuclide prior to medical use.
    (b) Measure, by direct measurement or by combination of 
measurements and calculations, the activity of each dosage of an alpha- 
or a beta-emitting radionuclide prior to medical use, except for unit 
dosages obtained from a manufacturer or preparer licensed pursuant to 
10 CFR 32.72 or equivalent Agreement State requirements;
    (c) * * *
    (2) Patient's or human research subject's name, and identification 
number if one has been assigned;
    (3) Prescribed dosage and activity of the dosage at the time of 
measurement, or a notation that the total activity is less than 1.1 
megabecquerels (30 microcuries);
* * * * *
    29. In Sec. 35.60, paragraphs (b) and (c) are revised to read as 
follows:


Sec. 35.60  Syringe shields and labels.

* * * * *
    (b) To identify its contents, a licensee shall conspicuously label 
each syringe or syringe radiation shield that contains a syringe with a 
radiopharmaceutical. The label must show the radiopharmaceutical name 
or its abbreviation, the clinical procedure to be performed, or the 
patient's or the human research subject's name.
    (c) A licensee shall require each individual who prepares a 
radiopharmaceutical kit to use a syringe radiation shield when 
preparing the kit and shall require each individual to use a syringe 
radiation shield when administering a radiopharmaceutical by injection 
unless the use of the shield is contraindicated for that patient or 
human research subject.
    30. Section 35.75 is revised to read as follows:


Sec. 35.75  Release of patients or human research subjects containing 
radiopharmaceuticals or permanent implants.

    (a) A licensee may not authorize release from confinement for 
medical care any patient or human research subject administered a 
radiopharmaceutical until either:
    (1) The measured dose rate from the patient or the human research 
subject is less than 5 millirems per hour at a distance of 1 meter; or
    (2) The activity in the patient or the human research subject is 
less than 30 millicuries.
    (b) A licensee may not authorize release from confinement for 
medical care of any patient or human research subject administered a 
permanent implant until the measured dose rate from the patient or the 
human research subject is less than 5 millirems per hour at a distance 
of 1 meter.
    31. Section 35.100 is revised to read as follows:


Sec. 35.100  Use of unsealed byproduct material for uptake, dilution, 
and excretion studies.

    A licensee may use for uptake, dilution, or excretion studies any 
unsealed byproduct material prepared for medical use that is either:
    (a) Obtained from a manufacturer or preparer licensed pursuant to 
10 CFR 32.72 or equivalent Agreement State requirements; or
    (b) Prepared by an authorized nuclear pharmacist, a physician who 
is an authorized user and who meets the requirements specified in 
Sec. 35.920, or an individual under the supervision of either as 
specified in Sec. 35.25.
    32. Section 35.200 is revised to read as follows:


Sec. 35.200  Use of unsealed byproduct material for imaging and 
localization studies.

    A licensee may use for imaging and localization studies any 
unsealed byproduct material prepared for medical use that is either:
    (a) Obtained from a manufacturer or preparer licensed pursuant to 
10 CFR 32.72 or equivalent Agreement State requirements; or
    (b) Prepared by an authorized nuclear pharmacist, a physician who 
is an authorized user and who meets the requirements specified in 
Sec. 35.920, or an individual under the supervision of either as 
specified in Sec. 35.25.
    33. Section 35.300 is revised to read as follows:


Sec. 35.300  Use of unsealed byproduct material for therapeutic 
administration.

    A licensee may use for therapeutic administration any unsealed 
byproduct material prepared for medical use that is either:
    (a) Obtained from a manufacturer or preparer licensed pursuant to 
10 CFR 32.72 or equivalent Agreement State requirements; or
    (b) Prepared by an authorized nuclear pharmacist, a physician who 
is an authorized user and who meets the requirements specified in 
Sec. 35.920, or an individual under the supervision of either as 
specified in Sec. 35.25.
    34. In Sec. 35.310, the introductory text of paragraph (a), and 
paragraphs (a)(1) and (a)(5) are revised to read as follows:


Sec. 35.310  Safety instruction.

    (a) A licensee shall provide radiation safety instruction for all 
personnel caring for the patient or the human research subject 
receiving radiopharmaceutical therapy and hospitalized for compliance 
with Sec. 35.75 of this chapter. To satisfy this requirement, the 
instruction must describe the licensee's procedures for:
    (1) Patient or human research subject control;
* * * * *
    (5) Notification of the Radiation Safety Officer in case of the 
patient's or the human research subject's death or medical emergency.
* * * * *
    35. In Sec. 35.315, the introductory text of paragraph (a), and 
paragraphs (a)(2), (a)(3), (a)(5), (a)(6), (a)(7), and (b) are revised 
to read as follows:


Sec. 35.315  Safety precautions.

    (a) For each patient or human research subject receiving 
radiopharmaceutical therapy and hospitalized for compliance with 
Sec. 35.75 of this chapter, a licensee shall:
* * * * *
    (2) Post the patient's or the human research subject's door with a 
``Radioactive Materials'' sign and note on the door or in the patient's 
or human research subject's chart where and how long visitors may stay 
in the patient's or the human research subject's room;
    (3) Authorize visits by individuals under age 18 only on a case-by-
case basis with the approval of the authorized user after consultation 
with the Radiation Safety Officer;
* * * * *
    (5) Either monitor material and items removed from the patient's or 
the human research subject's room to determine that their radioactivity 
cannot be distinguished from the natural background radiation level 
with a radiation detection survey instrument set on its most sensitive 
scale and with no interposed shielding, or handle them as radioactive 
waste.
    (6) Provide the patient or the human research subject with 
radiation safety guidance that will help to keep radiation dose to 
household members and the public as low as reasonably achievable before 
authorizing release of the patient or the human research subject.
    (7) Survey the patient's or the human research subject's room and 
private sanitary facility for removable contamination with a radiation 
detection survey instrument before assigning another patient or human 
research subject to the room. The room must not be reassigned until 
removable contamination is less than 200 disintegrations per minute per 
100 square centimeters; and
* * * * *
    (b) A licensee shall notify the Radiation Safety Officer 
immediately if the patient or the human research subject dies or has a 
medical emergency.
    36. Section 35.404 is revised to read as follows:


Sec. 35.404  Release of patients or human research subjects treated 
with temporary implants.

    (a) Immediately after removing the last temporary implant source 
from a patient or a human research subject, the licensee shall make a 
radiation survey of the patient or the human research subject with a 
radiation detection survey instrument to confirm that all sources have 
been removed. The licensee may not release from confinement for medical 
care a patient or a human research subject treated by temporary implant 
until all sources have been removed.
    (b) A licensee shall retain a record of patient or human research 
subject surveys for three years. Each record must include the date of 
the survey, the name of the patient or the human research subject, the 
dose rate from the patient or the human research subject expressed as 
millirem per hour and measured at 1 meter from the patient or the human 
research subject, the survey instrument used, and the initials of the 
individual who made the survey.
    37. In Sec. 35.406, paragraphs (a), (b), and (c) are revised to 
read as follows:


Sec. 35.406  Brachytherapy sources inventory.

    (a) Promptly after removing them from a patient or a human research 
subject, a licensee shall return brachytherapy sources to the storage 
area, and count the number returned to ensure that all sources taken 
from the storage area have been returned.
    (b) A licensee shall make a record of brachytherapy source use 
which must include:
    (1) The names of the individuals permitted to handle the sources;
    (2) The number and activity of sources removed from storage, the 
patient's or the human research subject's name and room number, the 
time and date they were removed from storage, the number and activity 
of the sources in storage after the removal, and the initials of the 
individual who removed the sources from storage;
    (3) The number and activity of sources returned to storage, the 
patient's or the human research subject's name and room number, the 
time and date they were returned to storage, the number and activity of 
sources in storage after the return, and the initials of the individual 
who returned the sources to storage.
    (c) Immediately after implanting sources in a patient or a human 
research subject the licensee shall make a radiation survey of the 
patient or the human research subject and the area of use to confirm 
that no sources have been misplaced. The licensee shall make a record 
of each survey.
* * * * *
    38. In Sec. 35.410, the introductory text of paragraph (a), and 
paragraphs (a)(3) and (a)(5) are revised to read as follows:


Sec. 35.410  Safety instruction.

    (a) The licensee shall provide radiation safety instruction to all 
personnel caring for the patient or the human research subject 
undergoing implant therapy. To satisfy this requirement, the 
instruction must describe:
* * * * *
    (3) Procedures for patient or human research subject control;
* * * * *
    (5) Procedures for notification of the Radiation Safety Officer if 
the patient or the human research subject dies or has a medical 
emergency.
* * * * *
    39. In Sec. 35.415, the introductory text of paragraph (a), and 
paragraphs (a)(1), (a)(2), (a)(3), (a)(5) and (b) are revised to read 
as follows:


Sec. 35.415  Safety precautions.

    (a) For each patient or human research subject receiving implant 
therapy, a licensee shall:
    (1) Not quarter the patient or the human research subject in the 
same room with an individual who is not receiving radiation therapy 
unless the licensee can demonstrate compliance with the requirements of 
Sec. 20.105(b) or, for licensees implementing the provisions of 
Secs. 20.1001-20.2401, through Sec. 20.1301(a) of this chapter at a 
distance of 1 meter from the implant;
    (2) Post the patient's or human research subject's door with a 
``Radioactive Materials'' sign and note on the door or in the patient's 
or human research subject's chart where and how long visitors may stay 
in the patient's or human research subject's room;
    (3) Authorize visits by individuals under age 18 only on a case-by-
case basis with the approval of the authorized user after consultation 
with the Radiation Safety Officer; and
* * * * *
    (5) Provide the patient or the human research subject with 
radiation safety guidance that will help to keep radiation dose to 
household members and the public as low as reasonably achievable before 
releasing the individual if the individual was administered a permanent 
implant.
    (b) A licensee shall notify the Radiation Safety Officer 
immediately if the patient or the human research subject dies or has a 
medical emergency.
    40. In Sec. 35.610, paragraph (a)(1) is revised to read as follows:


Sec. 35.610  Safety instruction.

    (a) * * *
    (1) The procedure to be followed to ensure that only the patient or 
the human research subject is in the treatment room before turning the 
primary beam of radiation on to begin a treatment or after a door 
interlock interruption;
* * * * *
    41. In Sec. 35.615, paragraphs (d)(3) and (e) are revised to read 
as follows:


Sec. 35.615  Safety precautions.

* * * * *
    (d) * * *
    (3) A radiation monitor must be checked with a dedicated check 
source for proper operation each day before the teletherapy unit is 
used for treatment of patients or human research subjects.
* * * * *
    (e) A licensee shall construct or equip each teletherapy room to 
permit continuous observation of the patient or the human research 
subject from the teletherapy unit console during irradiation.
    42. In Sec. 35.900, paragraphs (a)(4) and (a)(5) are revised and 
paragraphs (a)(6) through (a)(9) are added to read as follows:


Sec. 35.900  Radiation Safety Officer.

* * * * *
    (a) * * *
    (4) American Board of Science in Nuclear Medicine;
    (5) Board of Pharmaceutical Specialties in Nuclear Pharmacy;
    (6) American Board of Medical Physics in radiation oncology 
physics;
    (7) Royal College of Physicians and Surgeons of Canada in nuclear 
medicine;
    (8) American Osteopathic Board of Radiology; or
    (9) American Osteopathic Board of Nuclear Medicine; or
* * * * *
    43. In Sec. 35.910, paragraph (a)(3) is revised, paragraphs (a)(4) 
and (a)(5) are added, and paragraphs (b)(2)(i), (b)(2)(iii), and 
(b)(2)(v) are revised to read as follows:


Sec. 35.910  Training for uptake, dilution, and excretion studies.

* * * * *
    (a) * * *
    (3) Diagnostic radiology or radiology by the American Osteopathic 
Board of Radiology;
    (4) Nuclear medicine by the Royal College of Physicians and 
Surgeons of Canada; or
    (5) American Osteopathic Board of Nuclear Medicine in nuclear 
medicine; or
    (b) * * *
    (2) * * *
    (i) Examining patients or human research subjects and reviewing 
their case histories to determine their suitability for radioisotope 
diagnosis, limitations, or contraindications;
* * * * *
    (iii) Administering dosages to patients or human research subjects 
and using syringe radiation shields;
* * * * *
    (v) Patient or human research subject followup; or
* * * * *
    44. In Sec. 35.920, paragraphs (a)(2) and (a)(3) are revised, 
paragraphs (a)(4) and (a)(5) are added, and paragraphs (b)(2)(iii), 
(b)(3)(i), (b)(3)(iii), and (b)(3)(v) are revised to read as follows:


Sec. 35.920  Training for imaging and localization studies.

* * * * *
    (a) * * *
    (2) Diagnostic radiology by the American Board of Radiology;
    (3) Diagnostic radiology or radiology by the American Osteopathic 
Board of Radiology;
    (4) Nuclear medicine by the Royal College of Physicians and 
Surgeons of Canada; or
    (5) American Osteopathic Board of Nuclear Medicine in nuclear 
medicine; or
    (b) * * *
    (2) * * *
    (iii) Calculating and safely preparing patient or human research 
subject dosages;
* * * * *
    (3) * * *
    (i) Examining patients or human research subjects and reviewing 
their case histories to determine their suitability for radioisotope 
diagnosis, limitations, or contraindications;
* * * * *
    (iii) Administering dosages to patients or human research subjects 
and using syringe radiation shields;
* * * * *
    (v) Patient or human research subject followup; or
* * * * *
    45. In Sec. 35.930, the section heading and paragraphs (a)(1) and 
(a)(2) are revised and paragraphs (a)(3) and (a)(4) are added to read 
as follows:


Sec. 35.930  Training for therapeutic use of unsealed byproduct 
material.

* * * * *
    (a) * * *
    (1) The American Board of Nuclear Medicine;
    (2) The American Board of Radiology in radiology, therapeutic 
radiology, or radiation oncology;
    (3) Nuclear medicine by the Royal College of Physicians and 
Surgeons of Canada; or
    (4) The American Osteopathic Board of Radiology after 1984; or
* * * * *
    46. In Sec. 35.940, paragraph (a)(1) is revised to read as follows:


Sec. 35.940  Training for use of brachytherapy sources.

* * * * *
    (a) * * *
    (1) Radiology, therapeutic radiology, or radiation oncology by the 
American Board of Radiology;
* * * * *
    47. In Sec. 35.950, paragraphs (a)(1) and (a)(2) are revised and 
paragraph (a)(4) is added to read as follows:


Sec. 35.950  Training for use of sealed sources for diagnosis.

* * * * *
    (a) * * *
    (1) Radiology, diagnostic radiology, therapeutic radiology, or 
radiation oncology by the American Board of Radiology;
    (2) Nuclear medicine by the American Board of Nuclear Medicine;
* * * * *
    (4) Nuclear medicine by the Royal College of Physicians and 
Surgeons of Canada; or
* * * * *
    48. In Sec. 35.960, paragraphs (a)(1) and (b)(3)(iii) are revised 
to read as follows:


Sec. 35.960  Training for teletherapy.

* * * * *
    (a) * * *
    (1) Radiology, therapeutic radiology, or radiation oncology by the 
American Board of Radiology;
* * * * *
    (b) * * *
    (3) * * *
    (iii) Calculating the teletherapy doses and collaborating with the 
authorized user in the review of patients' or human research subjects' 
progress and consideration of the need to modify originally prescribed 
doses as warranted by patients' or human research subjects' reaction to 
radiation; and
* * * * *
    49. In Sec. 35.961, paragraph (b) is redesignated as paragraph (c) 
and a new paragraph (b) is added to read as follows:


Sec. 35.961  Training for teletherapy physicist.

* * * * *
    (b) Is certified by the American Board of Medical Physics in 
radiation oncology physics; or
* * * * *
    50. Section 35.972 is revised to read as follows:


Sec. 35.972  Recentness of training.

    The training and experience specified in this subpart must have 
been obtained within the 7 years preceding the date of application or 
the individual must have had related continuing education and 
experience since the required training and experience was completed.
    51. Section 35.980 is added to read as follows:


Sec. 35.980  Training for an authorized nuclear pharmacist.

    The licensee shall require the authorized nuclear pharmacist to be 
a pharmacist who:
    (a) Has current board certification as a nuclear pharmacist by the 
Board of Pharmaceutical Specialties, or
    (b)(1) Has completed 700 hours in a structured educational program 
consisting of both:
    (i) Didactic training in the following areas:
    (A) Radiation physics and instrumentation;
    (B) Radiation protection;
    (C) Mathematics pertaining to the use and measurement of 
radioactivity;
    (D) Chemistry of byproduct material for medical use; and
    (E) Radiation biology; and
    (ii) Supervised experience in a nuclear pharmacy involving the 
following:
    (A) Shipping, receiving, and performing related radiation surveys;
    (B) Using and performing checks for proper operation of dose 
calibrators, survey meters, and, if appropriate, instruments used to 
measure alpha- or beta-emitting radionuclides;
    (C) Calculating, assaying, and safely preparing dosages for 
patients or human research subjects;
    (D) Using administrative controls to avoid mistakes in the 
administration of byproduct material;
    (E) Using procedures to prevent or minimize contamination and using 
proper decontamination procedures; and
    (2) Has obtained written certification, signed by a preceptor 
authorized nuclear pharmacist, that the above training has been 
satisfactorily completed and that the individual has achieved a level 
of competency sufficient to independently operate a nuclear pharmacy.
    52. Section 35.981 is added to read as follows:


Sec. 35.981  Training for experienced nuclear pharmacists.

    A licensee may apply for and must receive a license amendment 
identifying an experienced nuclear pharmacist as an authorized nuclear 
pharmacist before it allows this individual to work as an authorized 
nuclear pharmacist. A pharmacist who has completed a structured 
educational program as specified in Sec. 35.980(b)(1) before (the date 
of publication in the Federal Register) and who is working in a nuclear 
pharmacy would qualify as an experienced nuclear pharmacist. An 
experienced nuclear pharmacist need not comply with the requirements on 
preceptor statement (Sec. 35.980(b)(2)) and recentness of training 
(Sec. 35.972) to qualify as an authorized nuclear pharmacist.
    53. In Sec. 35.991, paragraph (b) is revised to read as follows:


Sec. 35.991  Criminal penalties.

* * * * *
    (b) The regulations in Part 35 that are not issued under 
subsections 161b, 161i, or 161o for the purposes of section 223 are as 
follows: Secs. 35.1, 35.2, 35.7, 35.8, 35.12, 35.15, 35.18, 35.19, 
35.57, 35.100, 35.600, 35.901, 35.970, 35.971, 35.990, 35.991, and 
35.999.

    Dated at Rockville, Maryland, this 25th day of November, 1994.

    For the Nuclear Regulatory Commission.
John C. Hoyle
Acting Secretary of the Commission.
[FR Doc. 94-29525 Filed 12-1-94; 8:45 am]
BILLING CODE 7590-01-P