Repackaging of Certain Human 

 
Drug Products by Pharmacies 

 
and Outsourcing Facilities 
 
Guidance for Industry  

 
 
 
 
    
 
 
 
 
 
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services
  
Food and Drug Administration 
 
Center for Drug Evaluation and Research (CDER)
  
 
 
January 2017 

Compounding and Related Documents 
 
   


Repackaging of Certain Human 

 
Drug Products by Pharmacies 

 
and Outsourcing Facilities 
 
Guidance for Industry  

 
 
 
Additional  copies  are  available  from:  

Office  of Communications 
 
Division  of  Drug  Information,  WO51,  Room 2201 
 
Center  for  Drug Evaluation and  Research
  
Food and  Drug  Administration  

10903 New  Hampshire  Ave.,  Silver  Spring,  MD 20993  

Phone:  301-796-3400;  Fax:  301-847-8714  

druginfo@fda.hhs.gov 
  
http://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)
  
 
January 2017 

Compounding and Related Documents 
  Contains Nonbinding Recommendations  
 
TABLE OF CONTENTS  
 
 
 
I.   INTRODUCTION AND SCOPE ..................................................................................... 1 
 
II.   BACKGROUND  ............................................................................................................... 2 
 
A.   Repackaging, Generally  ................................................................................................................  2
  
B.   Regulatory Framework for Repackaging .................................................................................... 3
  
III.   POLICY ............................................................................................................................. 4 
 
A.   General Policy  ................................................................................................................................  4
  
B.   Establishment Registration and Drug Listing ........................................................................... 10 
 
   Contains Nonbinding Recommendations  
 
 	  Repackaging by entities that are not  State-licensed pharmacies, Federal facilities, or  
outsourcing facilities  (e.g., repackers registered with FDA under section 510 of the  
FD&C Act).  
	   Removing a drug product from the original container at  the point of care  (e.g., patients  
bedside)  for immediate administration to a single  patient after receipt of a  valid patient-
specific prescription or order for that patient (e.g., drawing up  a syringe  to  administer 
directly  to the patient).  FDA does not consider  this to be repackaging, for purposes of  
this guidance document. 
	   Upon receipt of a valid patient-specific prescription, a licensed  pharmacy removing from 
one container the quantity of non-sterile drug products5  (e.g., oral  dosage forms)  
necessary to fill the prescription and  placing  it in  a different container to dispense directly  
to the patient.  
 	  Investigational new drugs being studied under  an investigational new drug application. 
This guidance does not  alter  FDAs  existing approach to regulating investigational new  
drugs.  
 
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  
the word should in Agency guidances means that something is suggested or recommended, but  
not required.   
 
II.   BACKGROUND  
 
A.   Repackaging, Generally 
 
FDA regards repackaging as the act  of taking a finished drug product from the container in 
which it was distributed by the original manufacturer and placing it into a different container  
without further manipulation of  the drug.6  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 drug is manipulated in any other  
way, including if the drug is reconstituted, diluted, mixed, or combined with another  ingredient, 
that act is not considered  repackaging.7    
 
Repackaging is performed by a range of entities, including pharmacies and other  facilities that  
specialize in repackaging drug products.  FDA is aware that  repackaging is done for  a variety of  
                                                 
5  For  purposes  of  this  guidance,  a  sterile  drug is  a  drug that  is  intended for  parenteral  administration,  an ophthalmic  
or  oral inhalation drug in  aqueous  format,  or  a drug  that  is  required  to  be sterile under  Federal  or  State law.  
 
6  For  example,  if  tablets  are  removed from  a  blister  pack  and placed into  a  different  container,  that  would  be  
repackaging.  However,  if  the  blister  packs  containing  tablets  are placed  into  a  different  container  for  later  use  
(without  opening  the  individual  blister  packs),  that  would not  be  repackaging.  
 
7  This  guidance  does  not  apply  to the  compounding  of  drug products.   Compounding  is  addressed  in other  guidance  
documents.   See,  for  example, the  guidances  Pharmacy  Compounding of  Human  Drug Products  Under  Section 
503A  of  the  Federal  Food,  Drug,  and Cosmetic  Act  and For  Entities  Considering  Whether  to  Register  as  
Outsourcing Facilities  Under  Section 503B  of  the  Federal  Food,  Drug,  and Cosmetic  Act.    
  2  
    Contains Nonbinding Recommendations  
 
reasons including:  to meet the needs  of specific groups of patients (e.g., pediatric patients or  
patients receiving drugs for ophthalmic use)  who  require smaller doses of approved sterile  drug 
products  that may not be available commercially;  to reduce  medication errors associated with 
drawing up a dose from  a vial  at the  point of patient care; to reduce the  availability of drug  
products that could be  abused when controlled substances are left  over  in a vial  after  a dose is 
drawn out; to provide  a particular  sized container to fit into a particular device  to administer the  
drug (such as a particular pain medication pump); for convenience for the  practitioner  
administering an injection to a patient; to reduce  waste and conserve drug supplies; and in some  
cases to reduce cost.  Some repackagers repackage both sterile and non-sterile drug products.  
Examples of repackaging include  tablets  and capsules that are repackaged from large containers 
into smaller containers or blister packs, and creams and lotions  are sometimes purchased in bulk 
and repackaged into smaller tubes or  containers.    
 
As part of the drug application review  and approval  process, FDA  evaluates the container closure  
system and the packaging into which the drug will be placed, as well as  the conditions  under  
which the drug will be packaged.  The container closure  system and packaging can affect the  
quality of the drug product when it  is  on the market.  In particular, during the approval process, 
FDA reviews whether  the container closure system and the packaging are appropriate  for  
maintaining the stability of the drug product  through its expiration date, as long as the container-
closure  and package  are not  breached, and the drug is stored according to the conditions  
specified in the application.  For drug products  required to be sterile, FDA  also considers 
whether the container closure system  and packaging are  adequate to ensure that the  drug product  
will remain sterile until its expiration date, as long as the container  closure is not breached and  
the drug product is stored appropriately.   
  
When a drug product  is repackaged, its characteristics may  change in ways that have  not been 
evaluated during the  FDA approval  process and  that could affect the safety and efficacy of the 
drug product.  Improper repackaging of drug products  can  cause serious adverse events.  Of 
particular concern  is repackaging of  sterile drug products, which are susceptible to contamination 
and degradation.  For example, failure to properly  manipulate  sterile drug  products under  
appropriate aseptic  conditions  could introduce contaminants that could cause serious patient  
injury or death.  Repackaging practices that conflict with approved product labeling could result 
in drug product degradation and adverse events associated with impurities  in the product or lack  
of efficacy because the active ingredient has deteriorated.    
 
B.   Regulatory Framework  for Repackaging 
 
Repackaged drug products are  generally not  exempt from any of the provisions  of the FD&C Act  
related to the production of drugs.  For example, repackaged drug products are generally subject  
to the premarket approval, misbranding, adulteration, and drug supply chain security provisions  
of the FD&C Act, including section 505 (concerning new drug applications),8 section 502(f)(1)  
                                                 
8  But  see  U.S.  v.  Kaybel,  430 F.2d 1346  (3d Cir.  1970)  (holding  that  repackaging of  approved Enovid (estrogen)  
tablets  from  large  bottles  into  small  bottles  did  not  require  pre-approval under  section 505 of  the  FD&C  Act).  
 
  3  
    Contains Nonbinding Recommendations  
 
(concerning labeling with adequate directions for  use), section 501(a)(2)(B) (concerning current 
good manufacturing practice  (CGMP)), and section 582 (concerning drug supply chain security).  
 
Drugs that are repackaged are not subject  to sections 503A and 503B  of the FD&C Act.9  
Therefore, drug products  repackaged by State-licensed pharmacies, Federal facilities, or  
outsourcing facilities are  not eligible  for the exemptions provided under those sections.  In this  
guidance, FDA describes the conditions under which it does  not intend to take action regarding 
violations of certain requirements of the FD&C Act, in the context of drug repackaging. 
 
III.   POLICY  
     
A.   General  Policy10  
 
As discussed above, repackaged drug products are generally subject to the adulteration, 
misbranding, and approval provisions of the FD&C Act.11   FDA does not  intend to take action 
for violations of sections 505, 502(f)(1), and 582 if  a State-licensed  pharmacy, a Federal  facility,  
or an outsourcing facility repackages drug products  in accordance with the conditions described  
below, and any applicable requirements.12,  13 In addition, FDA does not intend to take  action for  
violations of section 501(a)(2)(B) of  the FD&C Act if the drug product  is repackaged by a State-
licensed pharmacy  or a Federal facility in accordance with the conditions described  below, and 
any applicable requirements.14   
 
The conditions  referred to  in the preceding paragraph are as follows:  
 
                                                 
9  Section  503A  of  the  FD&C  Act  exempts  compounded drug  products  from  sections  505,  502(f)(1),  and 
501(a)(2)(B)  of  the  FD&C  Act  provided certain conditions  are  met,  including that  the  drug  product is  compounded 
pursuant  to a  valid  prescription  for  an  individually  identified  patient from  a  licensed  practitioner.  The  Drug  Quality  
and  Security  Act  added  a  new  section  503B  to the  FD&C  Act.   Under  section  503B(b), a  compounder  can register  as  
an outsourcing  facility  with FDA.   Drug products  compounded  by or  under  the  direct  supervision  of  a licensed  
pharmacist  in an outsourcing facility  qualify for  exemptions  from  the  FDA  approval  requirements  in section 505  of  
the  FD&C Act,  the  requirement  to label  drug  products  with  adequate  directions  for  use  under  section  502(f)(1)  of  the 
FD&C  Act,  and the  Drug  Supply  Chain  Security  Act  requirements  in section  582 of  the  FD&C  Act,  if  the  conditions  
in  section  503B are  met.   Drug  products  compounded  in outsourcing  facilities  are  not  exempt  from  CGMP  
requirements  under  section  501(a)(2)(B).   
 
10  Portions  of  this  guidance  are  shaded  in gray  to indicate  that  they  constitute  collections  of  information  that  are  
subject  to review by  the  Office  of  Management  and Budget  under  the  Paperwork Reduction Act  of  1995 (44 U.S.C.  
3501-3520).   
 
11  See  footnote  8.  
 
12  Applicable  requirements  include,  for  example,  the  requirement  that  manufacturers  not  adulterate  a  drug  product  
by  preparing,  packing,  or  holding the  drug product  under  insanitary  conditions.   See  section  501(a)(2)(A)  of  the  
FD&C Act.   
 
13  FDA  is  considering the  applicability  of  the  policies  described  in this  guidance  to hospitals  and  health  systems  and 
intends  to  address  these  issues  in separate  guidance.  
 
14  For  purposes  of  the  applicability  of  the  conditions  in this  guidance  document,  references  to  a  State-licensed  
pharmacy  or  Federal  facility  do  not  include  a  facility  that  is  registered  as  an  outsourcing  facility  under  section  503B 
of  the  FD&C Act.   
  4  
    Contains Nonbinding Recommendations  
 
1.   The drug product that is being repackaged is a prescription drug product  that:  
 
a. 	  is approved under section 505 of the FD&C Act, or   
 
b. 	  is an unapproved drug product that appears on the drug shortage list in effect  
under section 506E of the FD&C Act, and the repackaged drug product  is  
distributed during any period in which it is listed on that drug shortage list or  
during the 30 days following such period.    
 
2. 	  The  drug product  is repackaged in a  State-licensed pharmacy, a  Federal facility, or  an 
outsourcing facility.   
 
3.	   The drug product is  repackaged by or under the direct supervision of a licensed 
pharmacist.  
 
4.	   If the drug product  is repackaged in  a  State-licensed pharmacy or  a Federal facility, it 
is  distributed15 only after the receipt of a valid  prescription for an identified, 
individual patient  (including a written order or notation in a  patients  chart in  a health  
care setting)  directly from  the prescribing practitioner or  patient.16  This condition 
does not apply to drug products repackaged in an outsourcing facility.17    
 
5. 	  Except as provided below for a single-dose  vial, the drug product  is repackaged, 
stored, and shipped in a  way that does not conflict with approved drug product  
labeling.18     
 
For a  drug product that is  packaged in a  single-dose vial that  is repackaged into 
multiple units, the drug product  is repackaged in a way that does not conflict with the  
                                                 
15  Distributed  means  that  the  repackaged  drug product  has  left  the  facility  in  which  it  was repackaged.  
 
16  FDA  is  considering  the  applicability  of  this  condition  to  certain  non-sterile  drug  products  repackaged by  State-
licensed  pharmacies  for  distribution  to  long-term  care facilities,  and intends  to revise  this  guidance  or  issue  separate  
guidance  to address  this  issue.   During  this  interim  period,  FDA  does  not  intend  to  apply  this  condition  to  non-sterile  
drug products  repackaged by State-licensed  pharmacies  for  use  in long-term  care  facilities.     
17  Note,  however,  that  drugs  produced by  outsourcing  facilities  remain subject  to the  requirements  in section  503(b)  
of the  FD&C  Act.   Therefore,  a  prescription  drug cannot  be  dispensed to a  patient  without  a  prescription.  
 
18  If  the  approved labeling contains  instructions  for  handling  or  storage  of  the  product,  the  drug product  is  
repackaged  in accordance  with those  instructions.   Otherwise,  the  repackaging would be  considered to be  in conflict  
with  the  approved  labeling.   For  example,  the  approved labeling  for  propofol  states  that  propofol  undergoes  
oxidative  degradation  in the  presence  of  oxygen and is  therefore  packaged under  nitrogen to  eliminate  this  
degradation  path,  and  it  states,  Do  not  freeze. Therefore,  exposing  propofol  to  oxygen during the  repackaging  
process  or  freezing  it  would  be  in  conflict  with  the  approved  labeling.   In  contrast,  the  labeling  of  propofol  is  silent  
on  the  type  of  container  into which it  can  be  packaged.   Therefore,  packaging it  into an appropriate  container  would  
not  conflict  with  the  approved  labeling.   Also  note  that  section  502(g)  of  the  FD&C Act  states  that  a  drug  is  
misbranded  if  it  is  a  drug that  is  recognized in an official  compendium  and  among other  things  it  is  not  packaged as  
prescribed therein.  
 
  5  
    Contains Nonbinding Recommendations  
 
approved labeling, except for the statements designating the  product as  a  single-dose  
or single-use product  and related language  (e.g., discard remaining contents).19  
 
6.	   The container into which the drug product is  repackaged is suitable for storage of the  
drug product  through its  beyond-use-date  (BUD).20  
 
7.   If the labeling for the approved drug product being repackaged includes storage  
and/or handling instructions (e.g., protect from light, do not freeze, keep  at specified  
storage temperature), the labeling for the repackaged drug product specifies the  same  
storage conditions.   
 
8. 	  The repackaged drug product is  assigned a BUD21,22  as described below, 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.  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.   
 
a. 	  Sterile drug products repackaged by State-licensed pharmacies or 
Federal facilities:  
 
i. 	  FDA-approved  drug  product  with  a specified in-use time: If the  
drug product being repackaged is  an FDA-approved drug product that  
specifies  in the labeling a time within which the opened product is  to 
be used (an in-use  time), the repackaged  drug product is  assigned a 
BUD (1) that is  established in accordance with  the in-use  time on the  
drug product being repackaged; or (2) that is  the expiration date on the  
drug product being repackaged, whichever  is shorter.23    
 
                                                 
19  This  condition  would not  be  satisfied if  a  drug product  repackaged from  a  single-dose  vial  is  repackaged  in a  way  
that  conflicts  with other  language  in the  approved labeling (e.g.,  regarding  storage  conditions).  
 
20  For  example,  for State-licensed  pharmacies  and  Federal  facilities,  information provided by  the  containers  
manufacturer  could indicate  that  the  container  is  suitable  for  drug  products  repackaged  in accordance  with  this  
condition.   For outsourcing  facilities,  CGMP  requirements  address  container  suitability  and  drug  stability.  
 
21  The  BUD  is  the  date  beyond  which a  drug product  should not  be  used.  
 
22  FDA does  not  intend  to take  action against  an outsourcing facility  for  assigning  a  BUD  to be  used as  an  expiration 
date  in lieu of  conducting  stability  studies  required  under  21  CFR  part  211  for  its  repackaged drug products  if  the  
outsourcing  facility  assigns  a  BUD  consistent  with  this  condition.    
 
23  For  example,  if  an approved drug product  that  includes  a  3-day in-use  time  and an expiration  date  of  January  15,  
2017,  on the  label  is  repackaged on  January  1,  2017,  the  applicable  BUD for  the  repackaged  drug  product  would  be  
January 4,  2017,  because the labeled  in-use  time  of  3 days  is  shorter  than the  time  until  the  labeled  expiration date  of  
the  drug  product  (14 days).   If  the  drug product  is  repackaged on  January  14,  2017,  the  applicable  BUD  for  the  
repackaged  drug product  would be  January 15,  2017,  because  the  time  until  the  labeled  expiration  date  of  the  
approved drug product  is  1 day,  which is  shorter  than the  labeled 3-day  in-use  time.  
 
  6  
    Contains Nonbinding Recommendations  
 
ii. 	  FDA-approved drug product without an in-use time or 
unapproved drug product:  If the  drug product being repackaged is  
an FDA-approved drug product whose labeling does not specify an in-
use time, or if it is  an unapproved drug product on the FDA drug 
shortage list (which does not  have  an in-use time reviewed by  FDA as 
part of the drug approval process), the repackaged drug product is  
assigned a BUD (1) that  is established in accordance with  the proposed 
revision to USP Chapter <797> published in the  Pharmacopeial Forum  
(PF) 41(6) [Nov.Dec. 2015] on November 2, 2015,24 or  (2) that is the  
expiration date on the drug product being repackaged, whichever is  
shorter.    
 
b.   Sterile drug products repackaged  by outsourcing facilities:    
 
The outsourcing facility assigns  a BUD as described in  the guidance,  
Current Good Manufacturing Practice  Interim Guidance for  
Human Drug  Compounding Outsourcing Facilities Under Section 
503B of the  FD&C Act.25  
 
c.	   Non-sterile drug  products  repackaged by State-licensed pharmacies,  
Federal facilities, or outsourcing facilities:26    
 
i.	   FDA-approved drug product  with a  specified in-use time:  If the  
drug product being repackaged is  an FDA-approved drug product that  
specifies in the labeling  an in-use time, the repackaged drug product  
is assigned a BUD (1) that is established in accordance with  the in-use 
time on the drug product being repackaged; or (2) that is  the expiration 
date on the  drug product being repackaged, whichever  is shorter.  
 
ii. 	  FDA-approved drug product without an in-use time or 
unapproved drug product:27    
                                                 
24  Once  USP  has  considered  the  public  comments  that  it  received  and  finalizes the revised Chapter  <797>,  FDA  
intends  to  evaluate  whether  condition  8  should refer  to the  updated chapter  or  BUDs  that  are  different  than  those  
included in final  Chapter  <797>.   Although USP  Chapter  <797>  addresses  compounded  sterile  preparations,  many  
of  the  same  principles  for  conditions  and practices  to assure  sterility  and stability  of  compounded  drug  products,  
such as  the  requirement  to maintain a  sterile  environment,  engage  in appropriate  sterile  processing techniques,  and 
assign  the appropriate  BUD  to  the  product,  also apply  to  repackaged sterile  drug products  to help  assure  their  quality  
is  not  compromised during and  after  the  repackaging  operation.  
 
25  The  longer  BUDs  set  forth  for  outsourcing  facilities  reflect  that  conditions  maintained  to  comply  with  CGMP  
requirements  provide  greater  assurance  of  the quality  of  manufacturing  operations  and  the products  that  are 
produced  at  the  facility,  and  that  outsourcing  facilities  are  subject  to  FDA  inspections  on  a  risk-based schedule.  
 
26  In  lieu  of  the  BUDs  set  forth  in  this  condition,  outsourcing facilities  may  establish  BUDs  for  non-sterile  drug  
products  that  they  repackage  based on  stability  studies  conducted  in  accordance  with  21  CFR Part 211.  
 
27  The  BUDs  in this  condition  are  based  on the  BUDs  applicable  to non-sterile compounded  preparations  in  USP  
Chapter  <795>.  
  7  
    Contains Nonbinding Recommendations  
 
 
 	  For nonaqueous formulations, the BUD does not exceed six 
months or the expiration date of the drug product  being 
repackaged, whichever is  shorter.  
 
 	  For water-containing oral formulations, the BUD does not exceed 
14 days or the expiration date of the drug product being 
repackaged, whichever is  shorter.  
 
 	  For water-containing topical/dermal and mucosal liquid and 
semisolid formulations, the BUD does not exceed 30 days or the  
expiration date of the drug product being repackaged, whichever is  
shorter.  
 
9. 	  The drug product is  repackaged in accordance with the following28:   
 
a. 	  If the drug product  is repackaged  in a State-licensed pharmacy or  a Federal  
facility:  
 
i. 	  If it is a  non-sterile drug  product, it  is repackaged  in accordance with  
USP Chapter <795>, except the BUD is as specified in condition 8; or  
 
ii. 	  If it is sterile drug product, it  is repackaged in accordance with USP  
Chapter <797>, except  the BUD is as specified  in condition  8.   
 
b. 	  If the drug product  is repackaged in an outsourcing facility, repackaging is 
conducted in accordance with CGMP requirements.29    
 
10.  The drug product that is being repackaged 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 ineffective.   For purposes of this  provision, repackagers should refer  
to the  list of drug products in 21 CFR 216.24, developed for use with sections 503A  
and 503B  of the FD&C Act. 
 
11.  The drug product is not  sold or transferred by an entity other than the  entity  that 
repackaged such drug product.  For purposes of this condition, a sale or transfer does  
not include  administration of a repackaged drug product  in a health  care setting.    
 
12.  The repackaged drug product  is distributed  only in States in which  the facility  
repackaging the drug product  meets all applicable State requirements.    
 
                                                 
28  The  intention  is  that  the  BUDs  are  set  in  accordance  with  condition  8.   
 
29  See  the guidance,  Current Good  Manufacturing Practice    Interim Guidance  for  Human  Drug  Compounding  
Outsourcing  Facilities  Under  Section  503B  of  the  FD&C Act.    
 
  8  
    Contains Nonbinding Recommendations  
 
13.  If the drug product  is repackaged by an outsourcing facility:  
 
a. 	  The  label on the immediate container (primary packaging, e.g., the syringe)  of 
the repackaged  product  includes  the following:  
i.   The statement This drug product was repackaged by [name of  
outsourcing facility]  
ii.   The address  and phone number of the outsourcing facility that  
repackaged the drug product  
iii. 	  The  established  name of the original  drug product  that was repackaged   
iv. 	  The lot or batch number of the repackaged drug product   
v. 	  The dosage  form and strength of  the repackaged drug product   
vi. 	  A  statement of  either the  quantity or volume of the repackaged drug 
product, whichever is  appropriate  
vii. 	  The date the drug product was repackaged 
viii.   The BUD as the expiry date for the  repackaged drug product  
ix. 	  Storage  and handling instructions for the repackaged drug product  
x.   The National Drug Code (NDC) number of the repackaged drug 
product, if  available30  
xi. 	  The statement Not for resale, and, if the drug product  is distributed  
by an outsourcing facility other  than pursuant  to a prescription for an 
individual  identified patient, the  statement Office Use  Only, and   
xii. 	  If included on the label of the drug product from  which the drug 
product  is being repackaged, a list of the active and inactive  
ingredients, unless such information is included on the label for the  
container from which the individual units are  removed, as described  
below in 11.b.i. 
 
b. 	  The label  on the container from  which the individual units are removed for  
administration (secondary packaging, e.g., the bag, box, or other package in 
which the repackaged products are distributed) includes:  
i. 	  The active and inactive ingredients, if the immediate drug product  
label is  too small to include this  information  
ii. 	  Directions for use, including, as appropriate, dosage and 
administration  
iii. 	  The following information to facilitate adverse event  
reporting:  www.fda.gov/medwatch and 1-800-FDA-1088. 
 
c. 	  The  drug product is  included on a report submitted to FDA each June and 
December identifying the drug products  repackaged by the outsourcing 
facility during the previous 6-month period, and providing the  active 
ingredient(s); source of the active ingredient(s); NDC number of the source  
ingredient(s), if available; strength of  the active  ingredient(s) per unit; the  
dosage form and route of administration; the package description; the number  
                                                 
30  The  NDC number  of  the  original  approved  drug product  should  not  be  placed on  the  repackaged drug product.  
 
  9  
    Contains Nonbinding Recommendations  
 
of individual units produced; and the  NDC number of the repackaged drug  
product, if  assigned.31  
 
d. 	  The  outsourcing facility  reports serious adverse events to FDA that  are  
associated with its repackaged drug products.32   
 
B.   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.  A drug is misbranded under section 
502(o) of the FD&C Act if it was manufactured, prepared, propagated, compounded, or  
processed in an establishment that is  not registered under section 510, or if it was not  included on 
a list required by section 510(j).  Pharmacies that repackage drug products  may qualify for an 
exemption from registration and  thus also not be required to list their drugs with FDA.  
Specifically, under section 510(g)(1),  the registration and listing requirements  of section 510 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 Act,33 FDA does not intend to take action for violations of section 502(o) of the  
                                                 
31  FDA has  issued a  guidance  for  industry,  Electronic  Drug  Product  Reporting for  Human Drug  Compounding 
Outsourcing  Facilities  Under  Section 503B  of  the  Federal  Food,  Drug,  and  Cosmetic  Act.   This  guidance  describes 
how  outsourcing facilities  submit drug product reports  to  FDA.   Although that  guidance  addresses  reporting of  
compounded drug products,  outsourcing  facilities  should follow the  same procedure to  electronically  report  the  drug  
products  they  repackaged.  
 
32  FDA has  issued a  guidance  for  industry,  Adverse  Event  Reporting for  Outsourcing Facilities  Under  Section  503B  
of  the  Federal  Food,  Drug,  and  Cosmetic  Act,  which describes  how  outsourcing  facilities  submit  adverse  event  
reports  to FDA and the  content  and  format of  the  reports  that  they  are  required  to submit.   Although  that  guidance  
addresses  reporting  of  adverse  events  associated with  compounded drug products,  outsourcing  facilities  should  
follow the  procedure  described in  that  guidance  to  electronically  report  adverse  events  associated with the  drug 
products  they  repackaged.    
 
33  See also,  21  CFR  207.10.  
 
  1 0 
    Contains Nonbinding Recommendations  
 
FD&C Act  for failure  to register and list drugs under section 510 for drugs  that are repackaged  in 
accordance with  this guidance.34    
                                                 
34  FDA has  developed this  policy  because outsourcing  facilities  that  repackage  drug products  in accordance  with this  
guidance  are  registered with FDA  under  section 503B  of  the  FD&C  Act and  report repackaged drug products  to 
FDA  in  accordance  with  condition  13.c.  
  1 1