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

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