ML20214S731
| ML20214S731 | |
| Person / Time | |
|---|---|
| Issue date: | 02/28/1986 |
| From: | Mccann G NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| To: | Gunabalan R TROY RADIOPHARMACY, INC., TROY, MI |
| Shared Package | |
| ML20214S716 | List: |
| References | |
| NUDOCS 8609300081 | |
| Download: ML20214S731 (22) | |
Text
.
FEB 2 81986 Troy Radiopharmacy, Inc.
ATTN:
Ram Gunabalan, M.D.
Director 3270 W. Big. Beaver Road Suite 115 Troy, MI 48084
Dear Dr. Gunabalan:
We have reviewed your application dated October 22, 1985 for an NRC Nuclear Pharmacy License. After review of your application, we find that additional information is necessary. This information must be submitted within 30 days from the date of this letter with regard to the following:
1.
Location of Use It appears that it is your intent-to utilize facilities' presently covered by another NRC licensee, i.e. Biomedical Diagnostic Services.
It is -
undesirable for two different legal entities to use licensed materials in the sanie facility.
For regulatory purposes, if workers or visitors are overexposed, it may be difficult to pin point primary responsibility for the improper practices.
If two different licensee's hold licenses, is one responsible or are they both responsible? This failure to establish clear lines of responsibility may result in the omission of necessary safety procedures or the assertion of conflicting procedures either condition may generate avoidable radiological hazards.
Based upon the above, it appears that there may exist only two options:
a.
Find different facilities for your nuclear pharmacy; or b.
Delete the facility from Biomedical Diagnostic Services, Ltd. license.
j l
Please specify which option you will pursue.
2.
Radiation Safety Officer (RS0) and Authorized Users Paragraph 30.33(a)(3) of 10 CFR Part 30 requires that applicants be qualified by training and experience to use licensed material for the purpose requested in their application.
It does not appear that either Mr. Slugaj or Mr. Emond have had previous or sufficient experience in the operation and/or control of a commercial radiopharmacy. Only those t
individuals whose training and experience meet or exceed that described in Appendix A (attached) will be authorized as users or as RSO.
8609300081 860512 REG 3 LIC30 PDR
Troy Radiopharmacy, Inc.
2 Due to public health and safety considerations necessary for a commercial nuclear pharmacy, your request for a waiver to the training and experience for Mr. Emond can not be approved.
Based upon the above, it will be necessary to submit additional training and experience for Messrs Slugaj and Emond which document that they satisfy the standards listed in Appendix A or submit name(s) and credential (s) for employees who do.
3.
Radiation Instrumentation and Calibration a.
Confirm that the high-level survey meter (i.e., capable of reading roentgens per hour) is adequately calibrated on all scales.
Review of.your consultant's report infers that they may not be capable of calibrating instruments that must read roentgen per hour exposure rates.
b.
Assure all calibration records will be maintained for at least two years.
c.
Please provide the NRC license number under which your consultant performs instrument calibrations.
d.
Page 26 of your application indicates that your dose calibrator will be calibrated in accordance with the procedures described in Section 2 of Appendix 0.
Specify the reference for these procedures or submit a copy. Attached.is a copy of procedures which are considered acceptable by this office (Appendix E).
4.
Facilities and Notification of State and Local Authorities a.
Identify state and local licenses and/or permits which are required to operate a commercial nuclear pharmacy, and submit evidence that such permits have been obtained.
b.
State and local government agencies should be notified early of plans to operate a nuclear pharmacy, because they often must respond to inquires from local citizens and organizations.
Indicate that such notifications have been made by submitting copies of letters to state and local government agencies and their comments. As of January 6, 1986, officials with the Michigan Department of Licensing and Registration, indicate that they have not received an application for a pharmacy license from Troy Radiopharmacy, Inc.
Troy Radiopharmacy, Inc.
3 c.
Describe arrangements made with local fire and police departments to inform them of your operation and to instruct them in appropriate emergency procedures.
Submit copies of correspondence sent to the local departments informing them of the pharmacy location and scope of operation, and inviting them to visit the-facility. Also confirm that similar notification will be performed annually.
5.
Training for Individuals Working in or Frequenting Restricted Areas a.
Submit a copy of the personnel training program which will be established (include a copy of an example " Radiation Safety Manual" used as part of your training program). You may state that you will adopt the training program described in Appendix C (attached) in lieu of the above submission.
b.
Identify the individual (s) and their qualification (s) who will provide the above training. You should give an approximate time spent on each training topic by worker type and the means to determine comprehension (i.e. tests and minimum scores to past).
In addition confirm that records documenting initial and refresher training will be maintained and that as a minimum, these records identify the individuals who conducted the training, the individuals who were trained, the cate of training, and the topics covered.
6.
General Rules for Safe Use of Radioactive Material Describe assay, records and their retention, and distribution procedures for technetinm-99m obtained from a molybdenum-99/ technetium-99m generator which will be followed by your staff.
The following statements would be considered acceptable:
a.
For each elution of technetium-99m from a molybdenum-99/ technetium-99m generator:
(1) Assay the eluate for technetium-99m in a dose calibrator; record the results and retain the record for 3 years after the assay.
(2) Test for total molybdenum-99 activity or test for molybdenum-99 concentration; record the results and retain the record for 3 years after the test (see paragraph 35.14(b)(4)(iii) of 10 CFR Part 35).
b.
Do not distribute technetium-99m for human use if the techr,etium-99m contains more than 1 microcurie of molybdenum-99 per millicurie of technetium-99m or if it contains more than 5 microcuries of molybdenum-99 per dose of technetium-99m at the expiratfon time and date shown on the package label. The expiration date and time shown on the label must be such that the limits specified above are not exceeded for any single patient dose.
Troy Radiopharmacy, Inc.
4 7.
Emergency Procedures a.
Confirm that copies of your emergency procedures will be posted in each area where radioactive material is used or stored.
b.
Describe the equipment and material in the form of a " decontamination kit" which will be maintained for rapid response to ' spills or other radioactive contamination emergencies.
Confirm that a kit will-be maintained in each restricted area.
8.
Area Survey Procedures Confirm that areas of contamination which exceeds 220 dpm per 100 cm2 but less than 2,200 dpm per 100 cm2, will either be covered, cleaned, or identified to all employees who have access to the affected area.
9.
Procedures for Retrieving Radiative Waste From Customers a.
Submit a copy of instructions to customers that will package radioactive waste for return to your facility.
Confirm that each customer will be provided with a copy of the above instructions.
b.
Describe what instructions are provided to your clients with regard to compliance with transport requirements, i.e. proper DOT labels, shipping papers, surveys, etc.
- 10. Operations a.
Submit a copy of a license or permit issued by the State Board of Pharmacy.
If you are in the application process, submit documentation verifying your application.
b.
Describe the expected limits to the geographical area your pharmacy will service. Confirm also that deliveries of radiopharmaceutical will be prescription only to physicians within the above specified geographical area.
c.
Confirm that radiopharmaceuticals prepared by tagging IND/NDA reagent kits are done in acccrdance with the manufacturers procedures printed on the labels of the reagent kit or the generator or both.
l Troy Radiopharmacy, Inc.
5 d.
' Clarify and describe in greater detail your definition of " kit sleeve" for reagent kits.
Is " original reaction vial container" the same as the manufacturers cardboard enclosure holding the styrofoam centainer which contains the multiple reaction vial? Also confirm that in addition to the manufacturers package insert, all documents (leaflets, brochures, etc.) supplied with the kits by the manufacturer which describe the procedures to be followed will be given to each customer.
11.
Product Labels Your submission and statement pertaining to product labeling is not acceptable, therefore, it will be necessary to submit the following information:
a.
Submit actual color samples of all labels that will accompany your products and describe where each label is placed (e.g., on the unit-dose syringe, on the container shield). The submission of another licensee's label is not acceptable, but must come from actual stock which will be used for labeling.
Furthermore, assure that each component of the radiopharmaceutical package is labeled.
b.
Paragraph 32.72(a)(4) of 10 CFR Part 32 requires that a label be affixed to each package of radiopharmaceutical or that a leaflet or brochure which accompanies each package contain the following statement, This radiopharmaceutical is licensed by the U.S. Nuclear Regulatory Commission for distribution to persons licensed pursuant to Section 35.14 and Section 35.100 Group of 10 CFR Part 35.
with the appropriate group designation placed in the blank. Based upon the above, submit a copy of the actual label, leaflet or brochure which will be used.
The use of the indicated Radiopharmaceutical Product Lists attached to your application is not an acceptable means of satisfying the required licensing statement unless you intend to send it with each shipment.
If this is your intent it will be necessary to submit revised sheets which identify them to your pharmacy and delete inaccurate data, e.g. gallium-67, thallium-201, are not licensed by the NRC.
3
Troy Radiopharmacy, Inc.
6 c.
Confirm that your labels for containers of radiopharmaceutical tagged with technetium-99m will also specify the total activity or concentration of molybdenum-99 and an expiration date and time to assure that no single patient dose-at the time of administration will contain more than 1 microcurie of molybdenum-99 per millicurie of technetium-99m or more than 5 microcuries of molybdenum-99 per dose of technetium-99m.
12.
Product Shielding a.
Describe in greater detail the maximum radiation exposure levels at the surface of each final source shield. Your statement under Item 4.b. on page 44 of your application is not acceptable.
Typically products containing technetium-99m should not read more than 2-3 milliroentgens per hour, whereas iodine-131 shipments have been approved as high as 40 milliroentgens per hour (for 6 millicuries).
b.
Describe in greater detail the construction of each of your shields (i.e., are they solid lead, an alloy, or are they lead with plastic coatings; is there any absorbent materials included in each vial container,etc.).
If your shields are commercially available 1
inclusion of the manufacturers products specification sheets would be useful.
13.
Procedures for Packaging and Transporting Radiopharmaceuticals a.
Submit a copy of the assessment and certification for your shipping
)
package design, i.e. the complete certification including safety analysis demonstrating that the construction methods, package design, and materials of construction are in compliance with applicable U.S. Department of Transportation Regulat;ons as required by Section 71.5 of the Code of Federal Regulations Part 71.
b.
Submit an actual copy of the shipping paper which will accompany each shipment of radioactive material.
c.
Submit actual color samples of the warning labels which will be attached to each of your shipping containers.
(
d.
Present regulations use Al and A2 values as points of reference for quantity limitations for every radionuclide. This system replaces the former " Transport Group" system that was used for limitations when the radioactive materials were in normal form.
Your " Transport Policies"' reference the outdated Group System.
Please submit revised policies which include consideration for A1/A2 values.
s
Troy Radiopharmacy, Inc.
7 e.
Submit an actual copy of the written instructions you will keep conspicuously available in your delivery vehicles for drivers, police or civil authorities in case of traffic accidents, etc. These instructions should describe in general terms the contents of the vehicle, provide telephone numbers of responsible nuclear pharmacy employees who can assist at the scene, and give general " common sense" instructions for the interim until an employee can reach the scene.
Your response to the above should be in duplicate and refer to Mail Control Number 80085.
Should you have any questions, you may contact us at (312) 790-5625.
Sincerely, Original Signed By George M. McCann Materials Licensing Section Attachments:
1.
Appendix A 2.
Appendix C.
3.
Appendix E i
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McCann/cm 6I*'
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