Recordkeeping - Radiopharmaceutical Compounding and Repackaging GFI, Biological Products GFI

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: [email protected]
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.
A.

POLICY ............................................................................................................................. 5
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 StateLicensed 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 FDA’s 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.”

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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 statelicensed 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 FDA’s 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, FDA’s guidance documents do not establish legally enforceable responsibilities.
Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only
as recommendations, unless specific regulatory or statutory requirements are cited. The use of

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.
6

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.

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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 center’s “hot lab” or hospital’s 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.

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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:
•
•

9

The addition of a supplemental amount of Tc-99m sodium pertechnetate to an FDAapproved 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.

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.

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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.

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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
patient’s 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 patientspecific 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.

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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 FDAapproved 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.

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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 FDA’s 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
prescriber’s 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 FDA’s 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.

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Contains Nonbinding Recommendations
regarding the status of the drug on FDA’s 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.

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4. The radiopharmaceutical is compounded or repackaged by or under the
supervision of an authorized nuclear pharmacist or authorized user22 in a statelicensed 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.

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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 patientspecific 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.

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