Compounding and Repackaging 
of Radiopharmaceuticals by 
State-Licensed Nuclear 
Pharmacies, Federal Facilities, 
and Certain Other Entities 
 
Guidance for Industry  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
 
 
September 2018 
Compounding and Related Documents
   
Compounding and Repackaging 
of Radiopharmaceuticals by 
State-Licensed Nuclear 
Pharmacies, Federal Facilities, 
and Certain Other Entities 
 
Guidance for Industry  
 
 
Additional copies are available from: 
Office of Communications, Division of Drug Information 
Center for Drug Evaluation and Research 
Food and Drug Administration 
10001 New Hampshire Ave., Hillandale Bldg., 4th Floor 
Silver Spring, MD 20993-0002  
Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353 
Email: druginfo@fda.hhs.gov  
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm 
 
 
 
 
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
 
September 2018 
Compounding and Related Documents 
  Contains Nonbinding Recommendations 
TABLE OF CONTENTS 
 
 
 
I.  INTRODUCTION AND SCOPE .................................................................................... 1 
II.  BACKGROUND ............................................................................................................... 3 
A.  Radiopharmaceuticals, Generally ................................................................................................ 3 
B.  Compounding, Generally .............................................................................................................. 4 
III.  POLICY ............................................................................................................................. 5 
A.  Radiopharmaceutical Compounding That Involves Manipulation Other Than Minor 
Deviations................................................................................................................................................. 6 
B.  Radiopharmaceutical Compounding that Constitutes Minor Deviations, and Repackaging .. 9 
C.   Establishment Registration and Drug Listing ........................................................................... 10 
  Contains Nonbinding Recommendations 
Compounding and Repackaging of Radiopharmaceuticals by State-
Licensed Nuclear Pharmacies, Federal Facilities, and Certain Other 
Entities 
Guidance for Industry1 
 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on 
this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can 
use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To 
discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title 
page.  
 
 
 
 
I.  INTRODUCTION AND SCOPE  
 
This guidance sets forth the FDAs policy regarding the compounding and repackaging of 
radiopharmaceuticals for human use by state-licensed nuclear pharmacies, Federal facilities, and 
other entities that hold a radioactive materials (RAM) license2 for medical use issued by the 
Nuclear Regulatory Commission (NRC) or by an Agreement State.3,4  
 
Under current law, radiopharmaceuticals that are compounded by entities that are not registered 
with FDA as outsourcing facilities, and radiopharmaceuticals that are repackaged, are subject to 
all applicable provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) related to the 
production of drugs. Because Congress explicitly excluded radiopharmaceuticals from section 
503A of the FD&C Act,5 compounded radiopharmaceuticals are not eligible for the exemptions 
under section 503A from section 505 (concerning new drug approval requirements), section 
502(f)(1) (concerning labeling with adequate directions for use), and section 501(a)(2)(B) 
(concerning current good manufacturing practice (CGMP) requirements). In addition, the FD&C 
Act does not provide an exemption for repackaged radiopharmaceuticals.  
                                                 
1 This guidance has been prepared by multiple offices in the Center for Drug Evaluation and Research and in 
consultation with the Office of Regulatory Affairs at the Food and Drug Administration. 
2 See 10 CFR 35.2 
3 The NRC defines an Agreement State in part as one that has entered into an agreement with the NRC under section 
274 of the Atomic Energy Act of 1954 (42 U.S.C. 2021). 
4 This guidance only applies to entities that are not registered with FDA as outsourcing facilities. Outsourcing 
facility refers to a facility that meets the definition of an outsourcing facility under section 503B(d)(4) of the FD&C 
Act. 
5 Section 503A of the FD&C Act describes the conditions that must be met for drug products compounded by a 
licensed pharmacist in a State-licensed pharmacy or Federal facility, or by a licensed physician, to qualify for 
exemptions from sections 505, 502(f)(1), and 501(a)(2)(B) of the FD&C Act. Section 503A(d)(2) of the FD&C Act 
states that this section shall not apply to . . . radiopharmaceuticals. 
 
1       Contains Nonbinding Recommendations 
 
FDA is issuing this guidance to describe the conditions under which the Agency generally does 
not intend to take action for violations of sections 505, 502(f)(1), and 501(a)(2)(B) of the FD&C 
Act when a state-licensed nuclear pharmacy, Federal facility, or other facility that is not an 
outsourcing facility and that holds a RAM license for medical use issued by the NRC or by an 
Agreement State compounds or repackages radiopharmaceuticals for human use.6  
 
This guidance does not address the following: 
  Mixing, reconstituting, combining, diluting, or repackaging of a radiopharmaceutical, or 
other such acts, performed in accordance with directions contained in the FDA-approved 
labeling.  
  Production of positron emission tomography (PET) drugs.  
  Drug products that are not radiopharmaceuticals.7  
  Radioactive biological products that are subject to licensure under section 351 of the 
Public Health Service (PHS) Act.  
  Radiopharmaceuticals for use in animals.  
  Compounding or repackaging of radiopharmaceuticals by entities that are not state-
licensed nuclear pharmacies, Federal facilities, or other facilities that are not outsourcing 
facilities and that hold a RAM license for medical use issued by the NRC or by an 
Agreement State. 
  Compounding or repackaging of radiopharmaceuticals by outsourcing facilities. See FDA 
guidance for industry Compounding and Repackaging of Radiopharmaceuticals by 
Outsourcing Facilities. 
 
In addition, this guidance does not alter FDAs current guidances addressing investigational new 
drugs. 
 
In May 1984, FDA issued guidance for industry on Nuclear Pharmacy Guideline Criteria for 
Determining When to Register as a Drug Establishment to describe activities of a nuclear 
pharmacy that would require the pharmacy to register as a drug establishment under section 510 
of the FD&C Act. This guidance supersedes the May 1984 guidance. 
 
In general, FDAs guidance documents do not establish legally enforceable responsibilities. 
Instead, guidances describe the Agencys current thinking on a topic and should be viewed only 
as recommendations, unless specific regulatory or statutory requirements are cited. The use of 
                                                 
6 In addition, the definition of product in section 581(13) of the FD&C Act excludes radioactive drugs from the 
drug supply chain security requirements of the FD&C Act, including section 582. 
7 FDA has issued guidance documents concerning its policies for compounding non-radiopharmaceutical drug 
products under section 503A of the Act. See, for example, FDA guidance flor industry Pharmacy Compounding of 
Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act. 
All FDA guidances are available on the FDA guidance web page. FDA updates guidances regularly. To make sure 
you have the most recent version of a guidance, always consult the guidance web page at 
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.  
 
2       Contains Nonbinding Recommendations 
the word should in Agency guidances means that something is suggested or recommended, but 
not required.  
 
II.  BACKGROUND 
 
A.  Radiopharmaceuticals, Generally 
 
Radiopharmaceuticals are radioactive8 sterile and non-sterile drugs that are used to diagnose, 
monitor, and treat diseases. Radiopharmaceuticals are used in diagnostic procedures and for 
therapeutic purposes. For example, during diagnostic procedures involving 
radiopharmaceuticals, the body is exposed to small amounts of radiation to observe organ 
function. Radiopharmaceuticals used for therapeutic purposes are generally administered in 
larger amounts to ensure that therapeutic doses of radiation are delivered to specific disease sites.  
 
Some radiopharmaceuticals are produced by a conventional manufacturer and shipped in hot 
(radioactive) multi-dose containers directly to an imaging center or hospital for patient 
administration. The imaging centers hot lab or hospitals nuclear pharmacy transfers the 
radiopharmaceuticals from the multi-dose containers into unit-dose, patient-ready containers, and 
sometimes manipulates the radiopharmaceuticals in other ways, such as by diluting or pooling 
them. Other radiopharmaceuticals are produced at the nuclear pharmacy by combining 
radioactive material eluted from a radionuclide generator with non-radioactive cold kits. The 
nuclear pharmacy prepares the radiopharmaceutical product using the components of the kit and 
by adding radioactive material eluted from a radionuclide generator for eventual administration 
to a patient.  
 
Because radioactive drugs generally have short half-lives (e.g., hours, a few days), they must 
reach the patient for administration soon after they are produced. Therefore, hospitals and 
imaging centers often place orders with a nuclear pharmacy for delivery of radiopharmaceutical 
unit-doses for procedures scheduled for the following day or in anticipation of unscheduled 
nuclear medicine procedures that might take place during the evening or weekend when the 
nuclear pharmacy is closed. 
 
There are legal restrictions as to who is permitted to obtain, transport, manipulate, and use 
radioactive drugs. At the Federal level, the NRC has established rules to protect the general 
                                                 
8 As used in this guidance, radiopharmaceutical and radioactive drug have the same meaning and refer to a drug 
that meets the definition in 21 CFR 310.3(n): any substance defined as a drug in section 201(g)(1) of the Federal 
Food, Drug, and Cosmetic Act which exhibits spontaneous disintegration of unstable nuclei with the emission of 
nuclear particles or photons and includes any nonradioactive reagent kit or nuclide generator which is intended to be 
used in the preparation of any such substance but does not include drugs such as carbon-containing compounds or 
potassium-containing salts which contain trace quantities of naturally occurring radionuclides. The term radioactive 
drug includes a radioactive biological product as defined in 600.3(ee) of this chapter. Radioactive biological 
product is defined in 21 CFR 600.3(ee) as a biological product which is labeled with a radionuclide or intended 
solely to be labeled with a radionuclide. However, as stated previously, this guidance does not apply to radioactive 
biological products. 
 
3       Contains Nonbinding Recommendations 
public, patients, and radiation workers from unnecessary exposure to radiation.9 The NRC and 
those states that have entered into certain agreements with the NRC (Agreement States)10 issue 
RAM licenses to authorize possession of specific types of radioactive materials and who may use 
the material under the license.11 Transport of radioactive materials is regulated by the NRC or the 
Agreement State and the U.S. Department of Transportation.12 
 
Separate from the RAM licenses issued by the NRC or an Agreement State, state boards of 
pharmacy may issue pharmacy permits to holders that receive, prepare, repackage, and/or 
dispense radioactive drugs. Certain states specifically recognize a separate category of 
pharmacists who practice as nuclear pharmacists and issue credentials specific for this practice.  
 
B.  Compounding, Generally 
 
1.   Compounding 
 
In this guidance, FDA regards compounding as the combining, admixing, mixing, diluting, 
pooling, reconstituting, or otherwise altering of a drug or bulk drug substance to create a drug.  
 
In some cases, pharmacists or other authorized users compound a radiopharmaceutical from an 
FDA-approved drug product with one or more minor deviations (as described below) that are 
necessary to accommodate circumstances not contemplated in the FDA-approved labeling, such 
as the rate of radioactive decay or geographical distance from the patient.  
 
For purposes of this guidance, FDA regards a minor deviation as a change from the approved 
labeling in radioactivity, volume, and/or the step-by-step procedures that does not adversely 
affect the quality of the product made when compounding the radiopharmaceutical from an 
FDA-approved drug product in a patient-ready dose. If the deviation adversely impacts product 
quality, then such change would not be minor and Section III.A below would apply to the 
radiopharmaceutical compounding. Examples of minor deviations include: 
 
  The addition of a supplemental amount of Tc-99m sodium pertechnetate to an FDA-
approved kit, so that the radiopharmaceutical can be provided to a patient with a later 
use time. 
  The use of an additional quantity of normal saline to reduce the concentration of the 
radiopharmaceutical in cases in which a supplemental amount of Tc-99m sodium 
pertechnetate has been added, as described above. In such cases, the additional 
radioactivity may necessitate a corresponding increase in volume so that the quantity 
of the radiopharmaceutical to be drawn up into a unit-dose syringe can be more 
precisely measured.  
                                                 
9 See 10 CFR parts 19, 20, and 35.  
10 See footnote 3. 
11 See 10 CFR 35.2. 
 
12 See 10 CFR 71.5, 49 CFR parts 107, 171 through 180, and 390 through 397.  
4       Contains Nonbinding Recommendations 
  A minor deviation in the step-by-step procedures for preparation that may result in 
the same finished radiopharmaceutical, but incorporates improvements in technology 
or decreased radiation exposure to pharmacy personnel. 
  The use of enhanced quality control procedures that have been shown to be superior 
to the recommended procedures. 
 
In other circumstances, manipulations of a radiopharmaceutical involve more significant 
deviations from the directions in FDA-approved labeling, or a radiopharmaceutical might be 
produced from a bulk drug substance. For example, to meet the needs of an identified individual 
patient, such as a patient with an allergy to a particular ingredient, a nuclear pharmacist or 
physician might compound a radiopharmaceutical that differs from an FDA-approved 
radiopharmaceutical in its inactive ingredients, dosage form, or mass dose, provided that product 
quality and safety are not compromised.  
 
There are also circumstances in which nuclear pharmacists and physicians compound 
radiopharmaceuticals from bulk drug substances when the FDA-approved radiopharmaceutical is 
discontinued or appears on the FDA drug shortage list.  
 
2.  Repackaging 
 
FDA regards repackaging of radiopharmaceuticals as the act of removing an FDA-approved 
radiopharmaceutical from the container in which it was distributed by the original manufacturer 
and placing it into a different container without further manipulation of the product. Repackaging 
also includes the act of placing the contents of multiple containers (e.g., vials) of the same 
finished drug product into one container, as long as the container does not include other 
ingredients. If a radiopharmaceutical is manipulated in any other way, including if it is 
reconstituted, diluted, mixed, or combined with another ingredient, that act is not considered 
repackaging. 
 
III.  POLICY 
 
As stated above, radiopharmaceuticals are generally not exempt from provisions of the FD&C 
Act related to the production of drugs.13 For example, radiopharmaceuticals are subject to the 
premarket approval, misbranding and adulteration provisions of the FD&C Act, including 
section 505, section 502(f)(1), and section 501(a)(2)(B).  
 
FDA recognizes that, although radiopharmaceuticals are not eligible for the exemptions in 
section 503A of the FD&C Act, there are circumstances in which state-licensed nuclear 
pharmacies, Federal facilities, and other facilities that are not outsourcing facilities and that hold 
a RAM license for medical use issued by the NRC or by an Agreement State compound or 
repackage radiopharmaceuticals to meet patient needs. FDA has developed this guidance to 
explain the conditions under which it generally does not intend to take action regarding 
                                                 
13 But see section 503B of the FD&C Act. FDA has addressed compounding of radiopharmaceuticals by outsourcing 
facilities under section 503B of the FD&C Act in the guidance document, Compounding and Repackaging of 
Radiopharmaceuticals by Outsourcing Facilities. 
5       Contains Nonbinding Recommendations 
violations of certain requirements of the FD&C Act when radiopharmaceuticals are compounded 
or repackaged by these entities. However, the Agency may take other factors into consideration 
when determining whether enforcement is appropriate in a particular case. 
 
Although radiopharmaceuticals addressed by this guidance are subject to the adulteration, 
misbranding, and new drug approval provisions of the FD&C Act, FDA generally does not 
intend to take action for violations of sections 505, 502(f)(1), and 501(a)(2)(B) of the FD&C Act, 
if a facility within the scope of this guidance compounds or repackages radiopharmaceuticals in 
accordance with the conditions described in Section A or B below, whichever is applicable, and 
any applicable requirements other than sections 505, 502(f)(1), and 501(a)(2)(B) of the FD&C 
Act.14  
 
A.  Radiopharmaceutical Compounding That Involves Manipulation Other 
Than Minor Deviations 
 
The conditions referred to immediately above for compounding of a radiopharmaceutical other 
than minor deviations are as follows: 
 
1.  The radiopharmaceutical is compounded by or under the supervision of an authorized 
nuclear pharmacist or authorized user15 in a state-licensed nuclear pharmacy, Federal 
facility, or other facility that holds a RAM license for medical use issued by the NRC 
or by an Agreement State. 
 
2.  The radiopharmaceutical is distributed16 after the receipt of a valid prescription order 
for an identified individual patient (which includes an order or a notation in the 
patients health record (e.g., chart) in a health care setting).  
 
3.  The radiopharmaceutical is stored and shipped in a way that does not conflict with 
approved drug product labeling. 
  
4.  If the radiopharmaceutical is compounded in advance of receipt of a valid patient-
specific prescription, it is compounded in a quantity that does not exceed the expected 
demand for the radiopharmaceutical within the beyond use date (BUD) of the 
product, based on a history of receipt of prescriptions for the radiopharmaceutical for 
that time period. The radiopharmaceutical is not distributed before the receipt of a 
valid prescription for an identified individual patient. 
 
                                                 
14 Applicable requirements include, for example, the requirement that manufacturers not adulterate a 
radiopharmaceutical by preparing, packing, or holding the drug product under insanitary conditions. See section 
501(a)(2)(A) of the FD&C Act. 
15 See definition of authorized nuclear pharmacist and authorized user at 10 CFR 35.2. 
16 Distributed means that the compounded or repackaged radiopharmaceutical has left the facility in which it was 
compounded or repackaged.  
 
6       Contains Nonbinding Recommendations 
5.  If the radiopharmaceutical is compounded using bulk drug substance(s), the bulk drug 
substance(s) comply with the standards of an applicable United States Pharmacopoeia 
(USP) or National Formulary (NF) monograph, if a monograph exists. If a 
monograph does not exist, the bulk drug substance(s) are components of a drug 
product approved under section 505 of the FD&C Act.17  
 
6.  If the radiopharmaceutical is compounded using bulk drug substance(s), the original 
manufacturer of the bulk drug substance(s) and any subsequent manufacturers, 
including repackagers, are establishments that are registered under section 510 of the 
FD&C Act (including a foreign establishment that is registered under section 510(i) 
of the FD&C Act), and each bulk drug substance is accompanied by a valid certificate 
of analysis. For purposes of this condition, original manufacturer means the entity 
that originally produced the bulk drug substance and not a subsequent packer, 
repackager, labeler, or distributor.  
  
7.  Radiopharmaceuticals may also contain other inactive ingredients such as a buffer, a 
stabilizer, or a preservative. If the radiopharmaceutical is compounded using 
ingredient(s) other than bulk drug substances, the ingredients comply with the 
standards of an applicable USP or NF monograph, if a monograph exists. 
 
8.  If it is a sterile radiopharmaceutical, it is compounded in compliance with USP 
Chapter <797>.18  
 
9.  The compounded drug product is assigned a BUD as described in <797> unless 
literature or other scientific information suggests that a shorter BUD would be 
appropriate, in which case a shorter BUD is assigned consistent with such scientific 
information. If the radiopharmaceutical is compounded using an FDA-approved drug, 
the BUD timeframe begins from the time in which the container of the original drug 
product is punctured or otherwise opened. 
 
10. The compounded radiopharmaceutical does not appear on a list of drug products that 
have been withdrawn or removed from the market because they have been found to 
be unsafe or not effective. For purposes of this condition, refer to the withdrawn or 
removed list at 21 CFR 216.24.  
 
11. The compounded radiopharmaceutical is not essentially a copy of a marketed FDA-
approved radiopharmaceutical.  
 
                                                 
17 FDA considers cold kits to be finished drug products. Therefore, preparation of a radiopharmaceutical from the 
components of a cold kit according to FDA approved labeling is not compounding. However, if an ingredient is 
added, or if the cold kit is otherwise manipulated in a manner not considered a minor deviation, it would be 
considered compounding for purposes of this guidance. 
18 USP is developing a new general chapter for sterile radiopharmaceutical compounding (<825> Compounding
Radiopharmaceuticals; see http://www.uspnf.com/notices/825-compounding-radiopharmaceuticals ). When this 
chapter is final, FDA intends to consider whether to revise condition 8. 
7       Contains Nonbinding Recommendations 
FDA intends to consider a compounded radiopharmaceutical to be essentially a copy 
of a marketed FDA-approved radiopharmaceutical if: 
 
  the compounded radiopharmaceutical has the same active ingredient(s) as the 
approved radiopharmaceutical;  
  the approved radiopharmaceutical can be used by the same route of 
administration as prescribed for the compounded radiopharmaceutical;  
  the approved radiopharmaceutical is not on FDAs drug shortage list (see 
section 506E of the FD&C Act) at the time of compounding and distribution; 
and 
  the approved product has not been discontinued and is currently marketed, 
 
unless there is a change that produces for an identified individual patient a clinical 
difference, as determined by the prescribing practitioner, between the compounded 
radiopharmaceutical and the comparable FDA-approved radiopharmaceutical, and the 
prescribers determination is documented in writing on the prescription or order by 
either (1) the prescribing practitioner, or (2) the compounder, reflecting a 
conversation with the prescribing practitioner.19 
 
If a compounder intends to rely on such a determination, the determination is 
documented on the prescription. This condition will be satisfied provided that the 
prescription makes clear that the prescriber identified the relevant change and the 
clinical difference produced for the patient, regardless of format. For example, the 
following would be sufficient for this condition:  
 
  No excipient X, patient allergic (if the comparable approved drug contains 
the excipient)  
 
However, if a prescription identifies only a patient name and radiopharmaceutical 
formulation, this would not be sufficient to establish that the prescriber made the 
determination described in this condition. Note also that to satisfy this condition, the 
clinical difference that the prescriber identifies must be produced by the change the 
compounder will make to a radiopharmaceutical (i.e., a change in drug product 
formulation). Other factors, such as a lower price, are not sufficient to establish that 
the compounded radiopharmaceutical is not essentially a copy of the approved 
radiopharmaceutical. If the compounder contacts the prescriber or health care facility 
to obtain the information described above, a notation should be added to the 
prescription or order. The notations should be as specific as those described above, 
and should include the date of the conversation with the health care facility contact or 
prescriber and the name of the individual who provided the determination. 
 
In addition, if the facility compounded a drug that is identical or nearly identical to an 
approved drug product that appeared on FDAs drug shortage list, the facility should 
maintain documentation (e.g., a notation on the order for the compounded drug) 
                                                 
19 See section IV of this guidance. 
8       Contains Nonbinding Recommendations 
regarding the status of the drug on FDAs drug shortage list at the time of 
compounding, distribution, and dispensing. 
 
12. The radiopharmaceutical that is being compounded is not identified (directly or as 
part of a category of drugs) on a list of drugs or categories of drugs that present 
demonstrable difficulties for compounding that are reasonably likely to lead to an 
adverse effect on the safety or effectiveness of the drug or category of drugs, 
taking into account the risks and benefits to patients. For purposes of this 
condition, refer to the list in FDA regulations at 21 CFR part 216.20 
 
13. The compounded radiopharmaceutical is not sold or transferred by an entity other 
than the entity that compounded such radiopharmaceutical. For purposes of this 
condition, a sale or transfer does not include administration of a compounded 
radiopharmaceutical in a health care setting.  
 
14. The compounded radiopharmaceutical is distributed only in states in which the 
compounding of the radiopharmaceutical meets all applicable state requirements.  
 
15. The radiopharmaceutical is compounded in accordance with all applicable 
requirements of the NRC or Agreement State (e.g., labeling requirements21) in a 
facility that meets all applicable requirements of the NRC or Agreement State, 
and the authorized nuclear pharmacist or authorized user who compounds or 
supervises the compounding of the radiopharmaceutical meets all applicable NRC 
or Agreement State requirements.  
 
B.  Radiopharmaceutical Compounding that Constitutes Minor Deviations, and 
Repackaging 
 
The conditions referred to above for compounding of a radiopharmaceutical that is limited to 
minor deviations as defined in Section II.B.1, or to the repackaging of a radiopharmaceutical, as 
defined in Section II.B.2, are as follows: 
 
1.  The radiopharmaceutical is compounded or repackaged from a drug product 
approved under section 505 of the FD&C Act. 
 
2.  No substances are added to the radiopharmaceutical unless they are specified in 
the FDA-approved labeling for the radiopharmaceutical being compounded. 
 
3.  If the radiopharmaceutical is compounded (and not repackaged), the 
compounding constitutes a minor deviation(s), as that term is defined above.  
 
                                                 
20 This list is under development. 
21 See 10 CFR 32.72(a)(4) or equivalent Agreement State requirements. 
 
 
9       Contains Nonbinding Recommendations 
4.  The radiopharmaceutical is compounded or repackaged by or under the 
supervision of an authorized nuclear pharmacist or authorized user22 in a state-
licensed nuclear pharmacy, Federal facility, or other facility that holds a RAM 
license for medical use issued by the NRC or by an Agreement State. 
 
5.  If it is a sterile radiopharmaceutical, it is compounded or repackaged in 
compliance with USP Chapter <797>.23 
 
6.  The repackaged drug product is assigned a BUD as described in <797> unless 
literature or other scientific information suggests that a shorter BUD would be 
appropriate, in which case a shorter BUD would be appropriate, in which case a 
shorter BUD is assigned consistent with such scientific information. The BUD 
timeframes in this condition begin from the time in which the container of the 
original drug product to be repackaged is punctured or otherwise opened. 
 
7.  The radiopharmaceutical is compounded or repackaged in accordance with all 
applicable requirements of the NRC or Agreement State (e.g., labeling 
requirements24) in a facility that meets all applicable requirements of the NRC or 
Agreement State, and the authorized nuclear pharmacist or authorized user who 
compounds or repackages, or who supervises the compounding or repackaging of 
the radiopharmaceutical, meets all applicable NRC or Agreement State 
requirements.  
  
8.  The compounded or repackaged radiopharmaceutical is distributed only in states 
in which the compounding or repackaging of the radiopharmaceutical meets all 
applicable state requirements.  
 
9.  The compounded or repackaged radiopharmaceutical is not sold or transferred by 
an entity other than the entity that compounded or repackaged such 
radiopharmaceutical. For purposes of this condition, a sale or transfer does not 
include administration of a compounded or repackaged radiopharmaceutical in a 
health care setting.  
 
C.  Establishment Registration and Drug Listing 
 
Under section 510(b)(1) of the FD&C Act, between October 1 and December 31 of each year, 
every person who owns or operates any establishment in any state engaged in the manufacture, 
preparation, propagation, compounding, or processing of a drug or drugs is required to register 
with FDA, and under section 510(j) of the FD&C Act, every person who registers with FDA 
under section 510(b) must list its drugs with the Agency. Pharmacies that compound or 
                                                 
22 See footnote 15. 
 
23 See footnote 18. 
 
24 See 10 CFR 32(a)(4) or equivalent Agreement State requirements. 
10       Contains Nonbinding Recommendations 
repackage radiopharmaceuticals may qualify for an exemption from registration and thus not be 
required to list. Specifically, under section 510(g)(1), the registration and listing requirements do 
not apply to: 
 
pharmacies which maintain establishments in conformance with any applicable local laws 
regulating the practice of pharmacy and medicine and which are regularly engaged in 
dispensing prescription drugs or devices, upon prescriptions of practitioners licensed to 
administer such drugs or devices to patients under the care of such practitioners in the 
course of their professional practice, and which do not manufacture, prepare, propagate, 
compound, or process drugs or devices for sale other than in the regular course of their 
business of dispensing or selling drugs or devices at retail.  
 
With respect to entities that do not qualify for the exemptions from registration under section 510 
of the FD&C Act25 (e.g., because they perform minor deviations without receiving patient-
specific prescriptions), FDA does not intend to take action under section 502(o) of the FD&C 
Act for failure to register and list radiopharmaceuticals that are compounded or repackaged in 
accordance with this guidance.  
 
 
                                                 
25 See also, 21 CFR 207.10. 
11