Issue Date: 07/01/08 - 1 - 87127 

 NRC INSPECTION MANUAL DILR/RGB 

INSPECTION PROCEDURE 87127

RADIOPHARMACY PROGRAMS 

PROGRAM APPLICABILITY: 2800 

87127-01 INSPECTION OBJECTIVES 

01.01 To determine if licensed activities are being conducted in a manner that will 

protect the health and safety of workers and the general public. 

01.02 To determine if licensed programs are being conducted in accordance with U.S. 

Nuclear Regulatory Commission (NRC) requirements. 

Note: Radiopharmacies may possess and operate an accelerator that produces 

Positron Emission Tomography (PET) radionuclides used to manufacture PET 

radioactive drugs. Inspection Procedure (IP) 87125 provides guidance on inspecting 

radionuclide production activities within these radiopharmacy facilities. 

87127-02 INSPECTION REQUIREMENTS 

The review of the licensed activities will be commensurate with the scope of the 

licensee's program. The inspector’s evaluation of a licensee’s program will be based 

on direct observation of work activities, interviews with workers, demonstrations by 

workers performing tasks regulated by NRC, and independent measurements of 

radiation conditions at the facility, rather than exclusive reliance on a review of records. 

The structure and the emphasis of the inspection will be on the following Focus 

Elements (FE) that describes the outcomes of an effective radiopharmacy radiation 

safety program: 

02.01 The licensee should control access to and prevent loss of licensed material so 

as to limit radiation exposure to workers and members of the public to values below 10 

CFR Part 20 limits. 

02.02 The licensee should maintain shielding of licensed materials in a manner 

consistent with operating procedures and design and performance criteria for devices 

and equipment. 

02.03 The licensee should implement comprehensive safety measures to limit other 

hazards from compromising the safe use and storage of licensed material. 
Issue Date: 07/01/08 - 2 - 87127 

02.04 The licensee should implement a radiation dosimetry program to accurately 

measure and record radiation doses received by workers or members of the public as a 

result of licensed operations. 

02.05 The licensee should provide radiation instrumentation in sufficient number, 

condition, and location to accurately monitor radiation levels in areas where licensed 

material is used and stored. 

02.06 The licensee should ensure that workers are: 

a. knowledgeable of radiation uses and safety practices; 

b. skilled in radiation safety practices under normal and accident conditions; and, 

c. empowered to implement the radiation safety program. 

02.07 The licensee’s management system should be appropriate for the scope of use 

and should ensure: 

a. awareness of the radiation protection program; 

b. that audits for ALARA practices are performed; and, 

c. that assessments of past performance, present conditions and future needs are 

performed and that appropriate action is taken when needed. 

In reviewing the licensee's performance, the inspector should cover the period from the 

last to current inspections. However, older issues preceding the last inspection should 

be reviewed, if warranted by circumstances, such as incidents, noncompliance, or high 

radiation exposures. 

87127-03 INSPECTION GUIDANCE 

General Guidance.

The following inspection guidance is designed to assist the inspector in evaluating the 

performance of the licensee’s radiation safety program. The guidance is organized by 

the individual focus elements described above. The timing and sequence of inspection 

activities are left to the inspector’s discretion based on the circumstances and 

conditions at the time of the actual inspection. Furthermore, inspectors should not feel 

constrained by the guidance in this procedure. If an inspector obtains information that 

indicates that a problem may exist in an area within the NRC’s jurisdiction that is not 

specifically addressed in this procedure, the inspector should redirect, or otherwise 

expend, inspection effort to address that problem. 

Some of the requirement and guidance sections of this procedure instruct the inspector 

to "verify" the adequacy of certain aspects of the licensee's program. Whenever 
Issue Date: 07/01/08 - 3 - 87127 

possible, verification should be accomplished through discussions, observations, and 

demonstrations. 

An examination of the licensee's records should not be considered the primary part of 

the inspection program. Rather, observations of activities in progress, equipment, 

facilities and use areas, etc., will be a better indicator of the licensee's overall radiation 

safety program than a review of records, alone. 

In the records reviewed, look for trends such as increasing doses or effluent releases. 

Records such as surveys, waste disposal, effluent releases, receipt and transfer of 

licensed materials, training, utilization logs, and air sampling may be examined 

randomly until the inspector is satisfied that the records are being maintained and are 

complete. Other records that are more closely related to health and safety (such as 

personnel dose-monitoring records and incident reports) should be examined in detail. 

Common elements to all inspections include preparation, entrance and exit meetings 

with appropriate licensee management, including the radiation safety officer (RSO), 

observations of facilities and work in progress, independent and confirmatory surveys, 

and the evaluation of program scope and any special license conditions. Specific 

guidance regarding these common elements can be found in IMC 2800. 

Specific Guidance.

Each of the following areas should be reviewed during each inspection of a 

radiopharmacy. 

03.01 FE-1: The licensee should control access to and prevent loss of licensed 

material so as to limit radiation exposure to workers and members of the public to 

values below 10 CFR Part 20 limits.

Facilities. 

a. Through direct observation, verify that all entrances to licensee facilities are 

normally closed, locked or otherwise secured to prevent unauthorized entry. 

This should include main facility gates, main building entrances, doors to waste 

storage facilities, etc. 

1. If any entrance or area is unsecured, determine, through questioning of 

licensee staff, the reason for the area or entrance being unsecured. 

Determine if the licensee failed to follow established procedures in 

securing the area or if additional training of staff is needed. Determine if 

the licensee’s facility is configured to separate working areas from 

unrestricted areas. 

2. If entrances or other areas are unsecured, examine areas where 

radioactive materials are used and stored. Storage areas must be locked 

and have limited and controlled access. Radioactive material use areas 

must be under constant surveillance or physically secured. 
87127 - 4 - Issue Date: 07/01/08 

b. Through observations, verify that use and storage areas, including radioactive 

waste storage facilities, are locked and have limited and controlled access. At a 

minimum, radioactive material use areas should be under constant surveillance 

during normal business hours when licensee personnel are present or physically 

secured against unauthorized access. Storage areas must be physically 

secured when unattended. 

Receipt and Transfer of Licensed Materials. 

a. Through observations and interviews of licensee personnel, verify that the 

licensee: 1) properly secures package receipt areas, such as loading docks or 

other shipping and receiving areas; 2) inspects packages for damage; 3) 

performs appropriate package receipt surveys; 4) opens packages in a safe 

manner; 5) assures that packages are properly prepared for transport; and 6) 

controls packages in a secure manner prior to pickup by courier personnel or 

transport by licensee personnel. If unable to observe the receipt of packages, 

request that personnel who normally receive packages for the licensee 

demonstrate package receipt processes and surveys. 

1. If packages are left unattended, assess the licensee’s receipt procedures, 

including instructions provided to couriers, to assure that packages are 

being delivered to the appropriate location(s). 

2. If surveys of packages (whether during receipt or preparation for 

shipment) are not adequate to verify that radiation and contamination 

levels are within regulatory limits, interview licensee staff and the RSO 

further to assess worker knowledge. Deficiencies regarding 

instrumentation should be reviewed in more depth in Focus Element 5 

(Section 03.05, below). 

b. Through interviews of licensee personnel and review of selected transfer 

documentation, verify that the licensee has an adequate method of determining 

that recipients of radioactive shipments are licensed to receive such materials. 

Inventory Control.

a. Through observation, physically examine the inventory of radioactive material 

on hand and review selected records of receipt and transfer to verify that 

quantities and forms are as authorized on the license. Compare the possession 

of selected sealed sources with inventory records. Verify that the licensee's use 

of byproduct material is limited to that which is authorized in the license. 

b. Through interviews of the RSO and selected licensee personnel, determine 

whether the licensee has experienced any events since the last inspection, 

involving lost, missing, or stolen licensed materials. 

1. Review and evaluate any such incident or unusual occurrence that took 

place since the last inspection. If such incidents were required to be 
Issue Date: 07/01/08 - 5 - 87127 

reported, verify, through interview of the RSO and review of event reports, 

that a complete and timely report was made to the NRC. 

2. For incidents or unusual occurrences that were not required to be 

reported, determine that the licensee performed sufficient investigation to 

identify the cause of the incident, and took appropriate corrections to 

prevent recurrence of the situation leading to the incident or unusual 

occurrence. 

03.02 FE-2: The licensee should maintain shielding of licensed materials in a manner 

consistent with operating procedures and design and performance criteria for devices 

and equipment.

Process and Engineering Controls.

Through observations, interviews of licensee personnel, and independent and 

confirmatory surveys, assess the adequacy of glove boxes, hot cells, mini-cells, remotehandling devices, transfer lines, shields and shielding devices, and other engineered 

safeguards to assure that they are adequate for the purposes for which they are 

intended. Specifically: 

a. For hot cells and mini cells, determine that the licensee controls: the access into 

hot cells or mini cells; the removal of material from process enclosures; and 

contamination originating within the hot cells or mini cells. 

1. If any weaknesses in hot cell and/or mini cell operations are identified, 

review the records of radiation surveys and/or air monitoring around the 

hot cell and/or mini cell area. 

2. If records indicate elevated radiation or airborne contamination levels, 

review the personnel monitoring records of individuals who worked in the 

area and verify that doses are within regulatory limits and ALARA. 

Continue follow up during evaluation of FE 03.04. 

b. For glove boxes, determine that the licensee: periodically checks the integrity of 

gloves and replaces gloves as necessary; controls the removal of material from 

process enclosures; and controls contamination originating within the glove 

boxes. 

 

1. If any weaknesses in glove box operations are identified, review the 

records of surveys around the glove box area and extremity monitoring 

records of individuals who work in the area. 

2. If records indicate elevated radiation or airborne contamination levels, 

review the personnel monitoring records of individuals who worked in the 

area and verify that doses are within regulatory limits and ALARA. 

Continue follow up during evaluation of FE 03.04. 
87127 - 6 - Issue Date: 07/01/08 

c. For temporary or portable shielding, verify that the licensee adequately controls 

the movement of the shielding to prevent inadvertent or unauthorized removal. 

d. For all processes where shielding is used, assess the adequacy of shielding 

during maximum loading of hot cells, mini cells, and glove boxes. Determine, by 

surveying the areas near manufacturing processes to ensure the continued 

adequacy of shielding. If the licensee initiates new processes in existing hot 

cells, mini cells or glove boxes, or utilizes new or additional transfer lines, 

determine whether the licensee has evaluated the adequacy of existing 

shielding before beginning the new process. 

e. For transfer of material, verify that the system(s) used for the transfer of 

materials has adequate shielding to keep exposures ALARA. Radiopharmacies 

that manufacture and/or handle PET radiopharmaceuticals generally use 

transfer lines and/or shielded containers to transfer radioactive material from the 

accelerator (if applicable) to the chemistry synthesis/compounding area and 

then to the drug dispensing area. If unable to observe the transfer of material, 

request that personnel describe the material transfer process. Also, request 

personnel to describe the procedures that would be used if material in the 

transfer line became trapped and/or leaked during transfer. 

Product Shielding

Ambient radiation levels should be determined for areas normally occupied by workers. 

If higher than expected readings are found, the inspector should determine the source 

of the higher dose rates. 

a. Through direct observations, interviews of licensee personnel, and independent 

measurements, verify that large quantities of stock or bulk radioactive materials 

are adequately shielded. Verify that such shielding cannot be easily removed or 

opened. Determine whether the licensee maintains adequate lifting equipment 

for such shields and that the equipment includes adequate safeguards to 

prevent dropped loads. 

b. Through direct observations and interviews of licensee personnel, verify that the 

licensee maintains an adequate supply of shields for unit quantities of 

radioactive materials, such as unit dose vials and syringes, and that licensee 

personnel use the shields when handling the containers. Verify that unit shields 

are adequate for the quantities and types of radioactive materials typically 

contained in them. 

c. Randomly select a number of finished products that are ready for distribution 

and verify that the external radiation levels are consistent with expected values. 

1. If higher than expected levels are noted, verify that the shielding included 

in prepared, distributed products conforms to that described in the license 

documents, as appropriate. 
Issue Date: 07/01/08 - 7 - 87127 

2. Verify that the licensee has not made changes to the size, shape, or 

contents (i.e., lead versus stainless steel or tungsten) of the shielding 

materials without prior approval of the NRC or an Agreement State. 

Routine and Non-Routine Maintenance

By interviewing selected maintenance personnel, review the licensee’s maintenance 

practices for equipment and components that include shielding for radiological safety. 

Determine that maintenance personnel verify, either through their own or health physics 

staff surveys, that radiological conditions are within acceptable limits prior to the 

removal of shielding from process equipment, or entering rooms or areas (such as 

bunkers, hot cells or accelerator vaults) normally posted as high radiation or very high 

radiation areas, or entering tanks or vessels that normally contain or have contained 

radioactive materials. Verify that shielding removed for maintenance and opened 

manways are properly replaced prior to lifting of maintenance holds when equipment is 

returned to service. 

For maintenance activities that include potentially significant radiological conditions, 

such as high dose rates (>100 millirem per hour general area or > 1 rem per hour 

contact) or contamination levels (>100,000 disintegrations per minute per 100 square 

centimeters), determine whether the licensee has established more stringent 

requirements, such as more detailed pre-job briefing of personnel, additional protective 

clothing, and/or constant job coverage by a health physics technician. 

Area Radiation Surveys

Through interviews of selected licensee personnel, including the RSO, verify that the 

licensee has established schedules for periodic surveys of work and storage areas of 

the facility site; verify that surveys are conducted using approved procedures; review a 

random selection of survey records to verify that surveys are performed according to 

schedules; verify that the survey results are reviewed by appropriate supervision; and 

verify that corrective actions have been taken, as appropriate. Attempt to observe 

surveys in progress by licensee personnel. Determine the adequacy of the surveyor's 

knowledge in checking the survey instrument for proper operation with a dedicated 

check source and in the use of the instrument for conducting radiation surveys. Verify 

specifically that schedule and procedural requirements for surveys are adequate to 

demonstrate compliance with the regulations and with pertinent license requirements. 

Determine whether due consideration is given to energy(particularly high energy 

photons from PET radiopharmaceuticals), beta exposure, and extremity exposure. 

Request that licensee personnel spot-check radiation levels in selected areas using the 

licensee's instrumentation. Compare the results with those obtained using the NRC's 

instruments. 

03.03 FE-3: The licensee should implement comprehensive safety measures to limit 

other hazards from compromising the safe use and storage of licensed material.

The inspector should be attentive to potential industrial safety hazards, for referral to 

the U.S. Department of Labor's Occupational Safety and Health Administration (see 
87127 - 8 - Issue Date: 07/01/08 

Manual Chapter 1007). The focus should be on potential non-radiological hazards 

personally observed or brought to the inspector’s attention by licensee staff. 

a. Fire Protection. In many cases, the risk posed to radiological safety by fires is 

comparable to or exceeds the risk from other events involving licensed 

activities. During the course of inspection of the licensee’s facilities, be alert to 

potential fire hazards. An effective licensee fire protection program should (1) 

prevent fires from starting, (2) rapidly detect, control, and extinguish those fires 

that do occur, and (3) provide protection for structures, systems, and 

components important to safety so that a fire that is not promptly extinguished 

by fire suppression activities will not prevent the licensee from taking actions to 

safely control licensed material and prevent the spread of contamination and 

unnecessary exposures to workers or the public. 

 Through observation and discussion with the licensee, while touring the 

facilities, assess firesafe conditions and equipment, i.e., that: (1) work areas 

are generally uncluttered and free of combustible debris, (2) incompatible 

materials (i.e., materials labeled as “corrosive”, “flammable”, or “oxidizer”) are 

isolated from each other and enclosed by fire resistant barriers, (3) fire detection 

systems are operable, (4) fire suppression systems are operable, (5) portable 

fire extinguishers are unexpired (check maintenance tags), (6) electric switches 

and electric motors are explosion-proof and open flames are administratively 

controlled in work areas that also contain flammable or combustible liquids or 

gases or highly reactive chemicals, and that (7) the local fire department is 

involved with the licensee’s fire protection program. 

 Any problems/deficiencies noted should be promptly brought to the licensee’s 

attention and discussed with Regional management. 

b. Industrial/Chemical Hazards. Through observations and interviews of licensee 

personnel, determine that the licensee controls the use/storage of hazardous 

(corrosive or combustible) chemicals near process equipment which could 

degrade their performance or render safety features inoperable. If the licensee 

is required to implement an emergency plan, verify that the plan includes these 

hazards, as appropriate, as initiating events. 

c. Transportation. Verify that licensed material is packaged and transported (or 

offered for transport) in accordance with 10 CFR Part 71 and U. S. Department 

of Transportation (DOT) regulations for transportation of radioactive materials. 

1. Observe the preparation of radioactive materials for shipment. Verify that 

the proper packaging is used for the type of materials/devices shipped. 

Verify that the licensee properly marks and labels packages in 

accordance with DOT requirements. Verify that the licensee performs 

appropriate examinations to confirm that package radiation and 

contamination levels are within applicable DOT limits prior to offering them 

for transport. Verify that proper shipping papers are prepared for each 

package/shipment and that, if necessary, the licensee maintains and 

offers appropriate placards to common carriers. 
Issue Date: 07/01/08 - 9 - 87127 

2. If the licensee tests and certifies its own DOT Type A packaging 

materials, review test procedures and required certification documentation 

for selected packages. Verify that the packaging materials are used in the 

same or similar configurations as in their certification testing. 

3. Verify that any DOT Type B containers are used in accordance with their 

Certificates of Compliance (COCs) issued by the NRC. The licensee 

must maintain copies of the COCs for the packages that it has used and 

ensure that it follows the instructions and limitations of the COCs when 

preparing the packages for shipment. 

4. If the licensee reported any transportation incidents, review the licensee’s 

actions in response to the incidents. 

03.04 FE-4: The licensee should implement a radiation dosimetry program to 

accurately measure and record radiation doses received by workers or members of the 

public as a result of licensed operations.

A radiation dosimetry program includes all of the licensee’s activities that measure the 

radiation dose to workers and members of the public as the result of licensed activities. 

These activities would include for example, the measurement of quantities of licensed 

materials present, radiation and contamination levels, and the concentration of licensed 

materials in effluent streams. 

a. Through interviews of the RSO, determine whether the licensee had made a 

prospective analysis of anticipated annual doses (internal and external) to 

workers. If the licensee’s analysis indicated that monitoring was not required, 

verify the assumptions and outcomes. 

b. If the licensee monitors worker exposures (internal and external), 

notwithstanding a prospective analysis indicating that monitoring was not 

required, review selected reports of monitoring results. Verify, based on the 

review of reports of monitoring results, that worker doses adequately reflect the 

nature and scope of the licensee’s activities. 

1. If monitoring results do not reflect the nature and scope of the licensee’s 

activities, or if there is wide variability in the range of doses for specific job 

categories (i.e., one pharmacist consistently receives significantly more 

exposure than all other pharmacists each month), discuss this variability 

with the RSO to determine that he/she is aware of the disparity. 

2. Through interviews of workers and observations of activities in progress, 

determine the basis for the disparity in doses or verify the RSO’s 

assessment of the disparity. 

c. Through interviews of workers and observations of activities in progress, verify 

that radiation monitors are worn appropriately and are recording the highest 

dose for which they are intended. 
87127 - 10 - Issue Date: 07/01/08 

1. If monitors are not (or cannot be) worn in the most appropriate location to 

record the highest dose received by the individual(s), through interviews of 

the RSO, verify that the licensee has performed assessments (through 

surveys, calculation, or both) of occupational exposures received and 

adjusted the dose of record for the worker(s). 

2. Review the results of the licensee’s assessment and verify the 

assumptions and outcomes. Verify that the dose of record for the 

affected worker(s) has been adjusted and that the adjusted dose is within 

the applicable regulatory limit and ALARA. 

 Note: For radiopharmacies that handle and/or produce PET 

radiopharmaceuticals, direct and indirect reading pocket-type dosimeters 

(i.e. electronic or filament-type) may be used by the licensee to estimate 

real-time dose. However, the inspector should verify that such pocket 

dosimeters are not used as the primary radiation monitoring device for 

determining the dose of record. 

d. Through interviews of the RSO and review of records of external monitoring 

results, determine whether processing (collection, process, and assessment) of 

monitoring devices is being performed in a timely manner. 

e. Through interviews of the RSO and workers who handle volatile radionuclides 

(i.e., radioiodine), verify that the licensee has established an appropriate 

monitoring frequency for the identification of intakes of radioactive materials. 

Verify that the licensee has established administrative action levels for 

investigating intakes. Through a review of bioassay records, verify that, when 

those levels are exceeded, the licensee appropriately investigates the intakes. 

Verify that the licensee’s process for converting intake measurements to dose 

uses appropriate calculations and methodologies. 

f. Through observations of facilities and activities in progress, interviews of the 

RSO and workers, independent and confirmatory measurements, and reviews 

of records of licensee evaluations, verify that the licensee effectively uses 

procedures and engineering controls to maintain doses to members of the 

public and radiation levels in unrestricted areas within regulatory limits and 

ALARA. 

g. Through observations of facilities and activities in progress, interviews of the 

RSO and workers, and reviews of records of air monitoring results and licensee 

evaluations, verify that licensee releases of gaseous radioactive effluents to 

unrestricted areas are within the constraint value. Verify that air 

sampling/monitoring equipment is calibrated and operational, and that sampling 

lines (if applicable) are intact and draw from their intended collection points. 

h. Through observations, and interviews of licensee personnel, including the RSO, 

determine whether the licensee periodically monitors in-line ventilation filtration 

systems for saturation. Determine whether filter systems are monitored for 
Issue Date: 07/01/08 - 11 - 87127 

differential pressure to ensure that there is no bypass of the filters, including 

perforations/channels and worn or degraded seals. 

i. Through observations, independent measurements, and interviews of licensee 

personnel, including the RSO, determine whether the licensee periodically 

monitors the flow rates of hot cells, mini cells, fume hoods and/or laminar flow 

hoods used to process licensed materials. Verify that licensee staff use 

calibrated instruments to measure flow rates. Verify that flow rates are 

adequate to prevent outflow of volatile, gaseous, and particulate materials into 

work areas, including the prevention of high eddy currents originating from 

excessive flow rates. 

j. Through observations, verify that respiratory protection equipment is certified by 

NIOSH/MSHA or otherwise approved by NRC. Determine that the licensee has 

selected the proper equipment for its licensed operations. Through interviews 

of the RSO, determine that the licensee has established a maintenance and 

training program for the use of respiratory protection equipment. Through 

interviews of selected workers who have used, or are designated/approved to 

use, respiratory protection equipment, determine that they are individually fitted 

for the type of respirators that they are expected to use and that respiratory 

equipment is operationally tested immediately prior to each use. 

k. Through reviews of dosimetry reports and annual licensee evaluations of public 

dose, and interviews of the RSO and selected licensee personnel, verify that 

the licensee has not experienced any events, since the last inspection, involving 

exposures to occupational workers or members of the public that were in excess 

of any regulatory limit. 

1. Review and evaluate any such incident or unusual occurrence that took 

place since the last inspection. If such incidents were required to be 

reported, verify, through interview of the RSO and review of event reports, 

that a complete and timely report was made to the NRC. 

2. For incidents or unusual occurrences that were not required to be 

reported, verify that the licensee performed sufficient investigation to 

identify the cause of the incident, and took appropriate corrections to 

prevent recurrence of the situation leading to the incident or unusual 

occurrence. 

03.05 FE-5: The licensee should provide radiation instrumentation in sufficient 

number, condition, and location to accurately monitor radiation levels in areas where 

licensed material is used and stored.

a. Through observations of portable radiation detection and measurement 

equipment in use and available for use, determine whether the quantity and 

type are adequate for the licensee’s radiation detection and measurement 

needs. Verify that instruments used to meet regulatory requirements (area and 

transportation surveys) have been calibrated. 
87127 - 12 - Issue Date: 07/01/08 

b. If the licensee uses a vendor to calibrate instruments, verify through interviews 

of the RSO that the vendor is authorized by the NRC or an Agreement State to 

perform that service. 

c. Through interviews and demonstrations, determine that licensee personnel who 

perform in-house instrument calibrations are knowledgeable of the calibration 

procedures for each type of instrument used by the licensee. Verify that 

calibrations include a determination of “as found” condition before adjustments 

are made. Verify that personnel understand how to maintain their doses (deep 

dose and extremity) ALARA during calibration procedures, especially if large 

activity sealed sources are used. 

d. If the licensee performs maintenance/repair on survey instruments, through 

interviews of appropriate licensee personnel and the RSO, determine whether 

the licensee possesses instrument manufacturer manuals and that any 

replacement parts used are “like-for-like.” 

e. Through observations and demonstrations, determine whether selected 

licensee survey instruments in use and available for use are operational (battery 

check) and respond appropriately to radiation (instrument source check). 

Compare licensee instrument readings to NRC instrument. Verify that 

licensee’s instrument response is comparable to NRC instrument (±20%). 

f. Through interviews of the RSO and workers, and by observation, determine 

whether the licensee has a system for tagging out inoperable and out-of-service 

survey instruments. 

g. Through observations and interviews of the RSO and workers, verify that the 

licensee’s instrumentation for performing in vivo bioassay measurements is 

adequate for those measurements. Determine that bioassay probes and 

scalers are compatible. Determine that licensee staff perform a response check 

using appropriate sources (such as a barium-133 source to simulate iodine-131) 

and a suitable background measurement before taking bioassay 

measurements. 

h. Through interviews of pharmacy staff and review of selected records, verify that 

the licensee performs appropriate checks and tests on each dose calibrator 

used to dispense dosages for distribution. Such checks and tests include 

constancy (to verify reproducible instrument response), linearity (to verify 

instrument response over the range of activities dispensed), accuracy (to verify 

appropriate energy response), and geometry dependence (to verify instrument 

response over the range of volumes and containers used to dispense 

radioactive materials). Verify that the licensee has established acceptance 

levels for each dose calibrator check and test, and that personnel performing 

the checks and tests are aware of them and understand the appropriate 

response if acceptance levels are not met. Determine whether any dose 

calibrators have been identified that failed a check or test and verify that 
Issue Date: 07/01/08 - 13 - 87127 

licensee’s response was appropriate. The inspector should request that 

licensee personnel demonstrate a dose calibrator constancy check. 

i. For each dose calibrator used to measure and dispense beta-emitters, verify 

through observations, interviews, and reviews of selected records, that the 

licensee has performed geometry dependence testing for each source/container 

configuration used and that the licensee has established appropriate calibration 

factors for each configuration used. 

03.06 FE-6: The licensee should ensure that workers are knowledgeable of radiation 

uses and safety practices; skilled in radiation safety practices under normal and 

accident conditions; and empowered to implement the radiation safety program.

a. Authorized Users. Authorized users may either be named in the license 

application or be appointed by the licensee, depending on the type of license 

issued and/or the wording in the license. For those appointed by the licensee, 

verify through interviews that the authorized user has knowledge commensurate 

with operational duties. In cases where users are specified by license condition, 

determine that the licensed materials they use conform to the license condition. 

 Determine that the authorized users are personally performing or, if permitted in 

the license, supervising, the authorized work, rather than someone else not 

named in the license. The level of supervision will depend on the wording in the 

license conditions or regulations. Some licenses have conditions such as "... 

used by or under the supervision of ...." For other types of licensees, 

supervision is defined in the regulations. For some licenses that have the 

condition "... under the direct supervision of ..," the authorized user must be 

physically present at the facility, for easy contact or to observe the individual(s) 

working. Another phrase used is "... may only be used by ...." Finally, "... under 

the direct supervision and physical presence of ..." means the authorized user 

must directly supervise and be present at the work station. CAUTION: 

Considering the many license condition phrases and regulations, exercise 

judgment when assessing the role of the authorized users. 

 When the wording of the license condition is "... used by or under the 

supervision of ...," an authorized user named on the license is considered to be 

supervising the use of licensed materials when he/she directs personnel in the 

conduct of operations involving the licensed material. This does not mean that 

the authorized user must be present at all times during the use of such 

materials. The authorized user/supervisor is responsible for assuring that 

personnel under his/her supervision have been properly trained and instructed, 

and is responsible for the supervision of operations involving the use of licensed 

materials whether he/she is present or absent. 

b. Authorized Nuclear Pharmacists (ANPs). ANPs may either be named on the 

license or appointed by the licensee. For those appointed by the licensee, 

verify that these individuals are qualified as ANPs in accordance with 10 CFR 

32.72 (b) and have knowledge commensurate with their operational duties. 
87127 - 14 - Issue Date: 07/01/08 

 The regulations in 10 CFR 32.72(b)(1) permit the nuclear pharmacy licensee to 

have an individual "under the supervision of" an authorized nuclear pharmacist 

prepare radioactive drugs for medical use. These regulations do not specifically 

require that the authorized user be present at all times during the use of such 

materials. However, the authorized user/supervisor is responsible for assuring 

that personnel under his/her supervision have been properly trained and 

instructed, pursuant to 10 CFR 35.27(b), and is responsible for the supervision 

of operations involving the use of radioactive materials whether he/she is 

present or absent. 

c. General Training. Certain kinds of training and instruction are found in the 

regulations; how they are implemented will be found in the license. Discuss with 

the licensee how, and by whom, training is conducted and the content of the 

training provided to workers (generally found in the license application). 

1. 10 CFR Part 19-Required Training. Verify, through interviews of selected 

licensee personnel, that initial instructions have been given to individuals 

who, in the course of employment, are likely to receive in a year an 

occupational dose in excess of 1 mSv (100 mrem). Under the basic 

instructions, it is management's responsibility to inform the workers of 

precautions to take when entering a restricted area, kinds and uses of 

radioactive materials in that area, exposure levels, and the types of 

protective equipment to be used. The workers should also be informed of 

the pertinent provisions of NRC regulations and the license, and the 

requirement to notify management of conditions observed that may, if not 

corrected, result in a violation of NRC requirements. Also verify that 

authorized users and workers understand the mechanism for raising 

safety concerns. 

2. Training Required by License Commitments. Of the training program 

elements in the license application, training given to authorized nuclear 

pharmacists, authorized users, and those individuals under the 

supervision of authorized users, is of primary importance. Through 

interviews of one or more users of radioactive materials, assess their 

understanding of the training that they have received, both in the basic 

instructions and that specified in the license application. For some 

licensees, this includes specific training needed to perform infrequent 

procedures and prepare and use radioactive material in research studies 

or in production. Note that the training should be (and in most cases is 

required to be) provided to workers before the individual's performance of 

licensed activities. 

 Through observation of related activities and discussions with selected 

licensee personnel, verify that they actually received radiation safety 

training. Authorized users and supervised individuals should understand 

the radiation protection requirements associated with their assigned 

activities. The licensee's radiation safety training may include, but is not 

limited to, demonstrations by cognizant facility personnel, formal lectures, 

testing, films, and "dry runs" for more complex or hazardous operations. 
Issue Date: 07/01/08 - 15 - 87127 

 Determine if ancillary workers (such as janitorial or clerical staff), contract 

workers, and visitors are informed about basic radiation safety practices 

for the type of material used by the licensee. 

 Determine, by observing and interviewing workers, if training and 

experience are adequate to enable users to safely undertake activities 

authorized by the license and whether they are aware of the risks 

involved. Examine the licensee's program for on-the-job training of new 

workers. Determine if there is adequate retraining for workers to cover 

regulation changes and/or radiation safety program changes that affect 

the workers. Review workers’ knowledge of the risks associated with the 

licensed activities. 

d. Operating and Emergency Procedures. Operating and emergency procedures 

will be found in license applications and may vary from step-by-step procedures 

to more generalized procedures for licensees with lower inspection priority. The 

emergency procedures may be approved by NRC and reviewed and updated by 

the licensee. However, licensees who follow the guidance in the appropriate 

NUREG 1556 series will likely develop procedures, including emergency 

procedures that have not received specific NRC review and approval. 

 Review and evaluate the licensee’s process for controlling documents 

(procedures) and making revisions to procedures. Revisions to operating 

procedures should be reviewed by licensee health physics staff to ensure that 

the revisions do not adversely affect radiological safety. Select a sample of 

operating or process areas and verify that pertinent procedures are available to 

personnel, are current, and are in use in those selected areas. If no operations 

are being performed, ask workers to describe their work and the procedures that 

govern their work activities. Determine whether process activities use 

procedures for reference or are required to be used “in-hand.” 

 During interviews of selected licensee personnel, assess the worker’s 

knowledge and understanding of the licensee’s emergency procedures, through 

proposed hypothetical emergency scenarios (i.e., “what if” questions). The 

scenarios should include those types of accidents appropriate to the licensee’s 

program (i.e., contaminated packages identified during receipt surveys, fires, 

contamination events involving large quantities (e.g., 100 millicuries of iodine131 or 1 curie of technetium-99m)). 

 If the licensee is required to have and implement an emergency plan, assess 

procedures for handling accidents including evacuation, prevention of spread of 

contamination, securing sources, handling accident victims, and any other major 

portions of the emergency plan. Verify, by discussions with workers, and review 

of procedures, that the emergency plan has been implemented and is being 

maintained. Verify that lines of communication with outside organizations that 

may be called on to assist in an emergency are current and tested. Ensure that 

biennial emergency plan drills and/or exercises include observation by NRC 

staff. 
87127 - 16 - Issue Date: 07/01/08 

 Some licensees may have agreements with other agencies (e.g., fire, law 

enforcement, and medical organizations) regarding response to emergencies. 

Discuss with the licensee's representatives what has been done to ensure that 

agencies (involved in such agreements) understand their roles in emergency 

responses. 

 

e. Posting and Labeling. Determine through observation whether proper caution 

signs are being used at access points to areas containing radioactive materials, 

radiation areas, and those areas containing airborne radioactive materials. 

Section 20.1903 provides exceptions to posting caution signs. When 

applicable, randomly examine signals and alarms to determine proper 

operation. Observe labeling on randomly selected packages or other containers 

to determine that proper information (e.g., isotope, quantity, and date of 

measurement) is recorded. 

 

 Areas with radiation hazards should be conspicuously posted, as required by 10 

CFR 20.1902. Depending on the associated hazard, controls may include tape, 

rope, or structural barriers to prevent access. If volatile radioactive materials 

are used in an area, such an area should be controlled for airborne 

contamination. High radiation areas should be strictly controlled to prevent 

unauthorized or inadvertent access. Such controls may include, but are not 

limited to, direct surveillance, locking the high-radiation area, warning lights, and 

audible alarms. Areas occupied by radiation workers for long periods of time 

and common-use areas should be controlled in accordance with licensee 

procedures and be consistent with the licensee's ALARA program. 

 Examine locations where notices to workers are posted. Applicable documents, 

notices, or forms must be posted in a sufficient number of places to permit 

individuals engaged in licensed activities to observe them on the way to or from 

any particular licensed activity location to which the postings would apply. 

03.07 FE-7: The licensee’s management system should be appropriate for the scope 

of use and should ensure awareness of the radiation protection program; that audits for 

ALARA practices are performed; and that assessments of past performance, present 

conditions, and future needs are performed, and that appropriate action is taken when 

needed. 

The NRC holds the licensee responsible for the radiation protection program; therefore, 

it is essential that strong management controls and oversight exist to ensure that 

licensed activities are conducted properly. Management responsibility and liability are 

sometimes under emphasized or not addressed in applications and are often poorly 

understood by licensee employees and managers. Senior management should 

delegate to the RSO sufficient authority, organizational freedom, and management 

prerogative to communicate with and direct personnel regarding NRC regulations and 

license provisions and to terminate unsafe activities involving byproduct material. 
Issue Date: 07/01/08 - 17 - 87127 

Through observations, interviews and the review of selected records, determine that 

senior licensee management is fulfilling its responsibility of ensuring the effective 

operation of the radiation safety program. Specific areas of management focus should 

include: 

• Maintaining awareness of significant events such as the loss or theft of licensed 

materials. 

• Maintaining radiation safety, security and control of radioactive materials, and 

compliance with regulations. 

• Committing adequate resources (including space, equipment, personnel, time, 

and, if needed, contractors) to the radiation protection program to ensure that 

members of the public and workers are adequately protected from radiation 

hazards and that compliance with regulations is maintained. 

• Obtaining the NRC's prior written consent before transferring control of the 

license; 

• Notifying the appropriate NRC regional administrator in writing, immediately 

following filing of petition for voluntary or involuntary bankruptcy (10 CFR 

30.34(h)). 

• Assuring the appropriate response, when applicable, to generic communications 

from the NRC. 

• Assuring that adequate provisions have been made to fund the safe and 

effective decommissioning of licensee facilities. (10 CFR 30.35) 

• Notifying the NRC of the decision to discontinue licensed activities or to 

decommission a facility in which licensed activities took place. (10 CFR 30.36) 

• Notifying the NRC of defects or other radiation safety equipment malfunctions in 

accordance with the requirements of 10 CFR, Part 21. 

• Maintaining awareness of issues and measures to ensure worker performance 

and safety are not being compromised due to safety significant human 

performance issues. 

a. RSC (where required or used). Through the review of records, and interviews of 

the RSO and RSC members, determine that the committee is made up of a 

representative from each type of program area, the RSO, and a representative 

from management. If practical, attend and observe the conduct of an RSC 

meeting. Review meeting minutes (and interview selected committee members 

when practical) to determine the committee's effectiveness. Determine that the 

RSC meets at the required frequency as specified in the license application, 

other commitment documents, or in a specific license condition. Topics of 

discussion during committee meetings should include ALARA reviews, 
87127 - 18 - Issue Date: 07/01/08 

incidents, generic communications, authorized users and uses, waste issues, 

audits, etc. 

 Determine if the committee has been assertive in seeking out areas needing 

improvement, rather than just responding to events and information from 

outside sources. Determine whether the RSC has recommended any specific 

actions and assess the implementation of those recommendations. The 

inspector's review should be of sufficient depth and detail to provide an overall 

assessment of the committee's ability to identify, assess, and resolve issues. 

Also consider the effectiveness of the RSC to communicate the results of audits 

and trend analyses to appropriate personnel performing licensed activities. 

b. RSO. Through the review of records, and interviews of the RSO and authorized 

users, verify that the RSO has been appointed by licensee management, 

identified on the license, and is responsible for implementing the radiation safety 

program. Determine, through interviews, that this individual is knowledgeable 

about the program, and ensures that activities are being performed in 

accordance with approved procedures and the regulations. Determine that, 

when deficiencies are identified, the RSO has sufficient authority, without prior 

approval of the RSC or licensee management, to implement corrective actions, 

including termination of operations that pose a threat to health and safety. 

 Determine that the knowledge and training of any radiation safety staff are 

commensurate with their assigned duties. Verify that the radiation safety staff 

levels, including numbers and types of positions, are as described in the license 

application. 

1. If the inspector identifies high staff turnover or prolonged shortfalls in 

staffing levels, through interviews and observation determine if these 

shortfalls have had a negative impact on licensee performance. 

2. If so, discuss these findings with the RSO and senior licensee 

management to determine the source of the staffing issues and the 

licensee’s plans to address the deficiency. The issue should also be 

brought to the attention of regional management. 

c. Audits. Through reviews of audit records and interviews, verify that the radiation 

safety program content and implementation is reviewed at least annually. The 

results of all audits must be documented in accordance with 10 CFR 

20.2102(a)(2). Examine these records with particular attention to deficiencies 

identified by the licensee’s auditors, and note any corrective actions taken as a 

result of deficiencies found. 

1. If no corrective actions were taken, determine why the licensee 

disregarded deficiencies identified during audits. 

2. Determine if the lack of corrective actions caused the licensee to be in 

non-compliance with regulatory requirements. 
Issue Date: 07/01/08 - 19 - 87127 

87127-04 REFERENCES 

A listing of IMCs and IPs applicable to the inspection program for materials licensees 

can be found in IMC 2800. Inspectors are to use these documents as guidelines in 

determining the inspection requirements for operational and radiological safety aspects 

of various types of licensee activities. 

END 

Issue Date: 07/01/08 Att1-1 

Attachment 1 

IP 87127 Revision History Page 

Commitment Tracking Number 

Issue Date Description of Change Training Needed Training 

Completion 

N/A 07/01/08 

CN-08-018 

This document has been revised to incorporate NRC’s new definition of byproduct material and regulatory authority over naturally occurring and accelerator produced radioactive material (NARM) 

Yes  (H-401 NARM Course)

8/29/2007