Registration of Human Drug 
Compounding Outsourcing Facilities 
Under Section 503B of the FD&C Act 
 
 
Guidance for Industry 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
 
Procedural 
November 2014 
 
 
 
  Contains Nonbinding Recommendations 
 
Registration of Human Drug 
Compounding Outsourcing Facilities 
Under Section 503B of the FD&C Act 
 
 
Guidance for Industry 
 
 
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  
Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353 
Email: druginfo@fda.hhs.gov  
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm 
or 
Office of Policy 
Office of the Commissioner 
Food and Drug Administration 
10903 New Hampshire Ave. 
Silver Spring, MD 20993 
Phone: 301-796-4830 
 
 
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
 
Procedural 
November 2014  Contains Nonbinding Recommendations 
 
TABLE OF CONTENTS 
 
 
I.  INTRODUCTION............................................................................................................. 1 
II.  BACKGROUND ............................................................................................................... 1 
A.  Drug Quality and Security Act ..................................................................................................... 1 
B.  Scope of this Guidance................................................................................................................... 2 
III.  REGISTERING WITH FDA AS AN OUTSOURCING FACILITY .......................... 3 
A.  Who Should Register ..................................................................................................................... 3 
B.  How to Register .............................................................................................................................. 3 
1. Method for Outsourcing Facility Registration ................................................................................. 3 
2. Method for Outsourcing Facility De-Registration ........................................................................... 3 
3. Posting of Registration Information ................................................................................................ 4 
C.  Electronic Registration Waivers ................................................................................................... 4 
D.  Registration Fees ............................................................................................................................ 4 
 
 
 
  Registration of Human Drug Compounding Outsourcing Facilities 
Under Section 503B of the FD&C Act 
 
1
Guidance for Industry  
 
 
 
 
This guidance represents the Food and Drug Administrations (FDAs or Agencys) current thinking on 
this topic.  It does not create or confer any rights for or on any person and does not operate to bind FDA 
or the public.  You can use an alternative approach if the approach satisfies the requirements of the 
applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff 
responsible for implementing this guidance.  If you cannot identify the appropriate FDA staff, call the 
appropriate number listed on the title page of this guidance.  
 
 
 
I.  INTRODUCTION 
 
This guidance is intended for facilities planning to register or renew registration as human drug 
compounding outsourcing facilities (outsourcing facilities).  A compounder can elect to register 
with FDA as an outsourcing facility under section 503B of the Federal Food, Drug, and 
Cosmetic Act (FD&C Act) (21 U.S.C. 353b), as added by the Drug Quality and Security Act 
(DQSA), Pub. Law No. 113-54 (November 27, 2013).  This guidance describes the process for 
electronic submission of establishment registration information for outsourcing facilities. In 
certain rare cases, FDA may grant an entity a waiver from submitting registration information 
electronically.  This guidance also provides information on how to obtain such a waiver. 
 
FDAs guidance documents, including this guidance, do not establish legally enforceable rights 
or 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.  Drug Quality and Security Act 
   
The DQSA adds new section 503B to the FD&C Act.  Under section 503B(b) of the FD&C Act, 
a compounder can elect to become an outsourcing facility and register with FDA.  Each 
outsourcing facility must report to FDA certain information about the drug products it 
                                                 
1 This guidance was prepared by the Office of Compliance, Center for Drug Evaluation and Research, at the Food 
and Drug Administration. 
1 
  Contains Nonbinding Recommendations 
 
compounds.  If the requirements in section 503B are met, drug products compounded in an 
outsourcing facility can qualify for exemptions from the FDA approval requirements in section 
505 of the FD&C Act (21 U.S.C.355) and the requirement to label products with adequate 
directions for use under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)).  Outsourcing 
facilities will be inspected by FDA and must comply with other provisions of the FD&C Act, 
such as current good manufacturing practice (CGMP) requirements.2   
 
After the initial registration, under section 503B(b) of the FD&C Act, a facility that elects to 
register with FDA as an outsourcing facility must also do so annually for each year thereafter 
that it wishes to remain an outsourcing facility, during the registration period between October 1 
and December 31.To register as an outsourcing facility a compounder must provide its name, 
place of business, a unique facility identifier3, and a point of contact email address (section 
503B(b)(1)(A)(i)).  The facility must also indicate whether it intends to compound, within the 
next calendar year, a drug that appears on FDAs drug shortage list in effect under section 506E 
of the FD&C Act (21 U.S.C. 356e) (section 503B(b)(1)(A)(ii)), and whether it compounds from 
bulk drug substances, and, if so, whether it compounds sterile or nonsterile drugs from such bulk 
drug substances.4 
 
B.  Scope of this Guidance 
 
This guidance document describes the process for registering as an outsourcing facility under 
section 503B of the FD&C Act. Separate guidances provide instructions on payment of 
registration fees and how outsourcing facilities should report to FDA the drug products they 
compound.5  This guidance reflects FDAs current thinking in light of existing data standards, 
information technology, and information management resources.  As these variables change over 
time, FDA may revisit this guidance and the specifications described in section III of this 
guidance. 
 
                                                 
2 FDA has issued a draft guidance on this topic (Current Good Manufacturing Practice  Interim Guidance for 
Human Drug Compounding Outsourcing Facilities Under Section 503Bof the FD&C Act).  Once finalized, that 
guidance will represent the Agencys thinking on this topic.  
FDAs guidances are available on its guidance website.  FDA updates guidances regularly. To make sure you have 
the most recent version of a guidance, visit the guidance website at 
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.  
3 See the guidance for industry Specification of the Unique Facility Identifier (UFI) System for Drug Establishment 
Registration.  Although this guidance is intended to address provisions set forth in section 510 of the FD&C Act, 
FDAs specification of the UFI system in this guidance also applies to facilities that register as outsourcing facilities 
under section 503B of the FD&C Act.   
4 Although section 503B(b)(1)(A) does not specifically identify this information regarding bulk drug substances, 
section 503B(b)(1)(B)(ii) requires FDA to publish this information on the Internet (see section III.B.3 below). 
Therefore, FDA is requiring that this information be supplied as part of the registration submission. 
5 See guidances for industry Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and 
744K of the FD&C Act and Electronic Product Reporting for Human Drug Compounding Outsourcing Facilities 
Under Section 503B of the Federal Food, Drug, and Cosmetic Act.      
    2   
  Contains Nonbinding Recommendations 
 
III.  REGISTERING WITH FDA AS AN OUTSOURCING FACILITY 
 
A.  Who Should Register 
 
A compounder can elect to register with FDA as an outsourcing facility.  An outsourcing facility 
engages in the compounding of sterile drugs.  Each outsourcing facility at a separate geographic 
location or address must register separately.  The outsourcing facility is not required to be a 
licensed pharmacy (although it may be a licensed pharmacy), and it may or may not obtain 
prescriptions for individual patients.6 
 
B.  How to Register 
 
1.  Method for Outsourcing Facility Registration 
 
Facilities that elect to register with FDA as outsourcing facilities should submit registration 
information using the existing structured product labeling (SPL) format.  For detailed 
instructions on how to submit information using SPL, outsourcing facilities should refer to 
section IV of the guidance for industry Providing Regulatory Submissions in Electronic Format 
 Drug Establishment Registration and Drug Listing.  FDA also offers tools and information for 
creating and submitting SPL files. Additional information can be found at www.fda.gov/edrls. 
 
After initial registration, facilities must register annually, between October 1 and December 31 
of each year, to continue to be registered outsourcing facilities.  FDA has created an SPL 
category of business operation for outsourcing facilities.  All outsourcing facilities should submit 
establishment registration information using the business operation Human Drug Compounding 
Outsourcing Facility.  If a facility chooses to register as an outsourcing facility, as required by 
section 503B(b)(1)(A) of the FD&C Act, it must submit the following information: 
 
  Name of the facility 
  Place of business 
  Unique facility identifier  
  Point of contact email address and phone number7 
  An indication of whether the facility intends to compound products on FDAs drug 
shortage list  
  An indication of whether the facility compounds from bulk drug substances, and if so, 
whether it compounds sterile or nonsterile drugs from bulk drug substances8 
 
2.  Method for Outsourcing Facility De-Registration 
 
Facilities that have registered with FDA as outsourcing facilities can withdraw registration by 
submitting information to de-register using the SPL format.  For detailed instructions on how to 
                                                 
6 Section 503B(d)(4) of the FD&C Act 
7 Section 503B(b)(1)(A) only requires registrants to include a point of contact email address.  However, we 
recommend that registrants also supply a point of contact phone number. 
8 See footnote 4 above. 
    3   
  Contains Nonbinding Recommendations 
 
de-register, see section IV of the guidance for industry Providing Regulatory Submissions in 
Electronic Format  Drug Establishment Registration and Drug Listing. 
 
3.  Posting of Registration Information 
 
Section 503B(b)(1)(B)(ii) of the FD&C Act requires FDA to publish on the Internet a list of 
registered outsourcing facilities that includes the name of each registered outsourcing facility, the 
state in which it is located, whether the facility compounds from bulk drug substances, and 
whether such compounding from bulk drug substances is for sterile or nonsterile drugs.9  FDA 
will publish the required information including the date the facility registered as an outsourcing 
facility, as well as certain publicly disclosable information related to past FDA inspections and 
compliance actions.  FDA intends to update the list of registered outsourcing facilities weekly.  
 
C.  Electronic Registration Waivers 
 
Section 503B(b)(3) of the FD&C Act requires facilities to register by electronic means unless 
FDA grants a request for a waiver of this requirement because use of electronic means is not 
reasonable for the person requesting the waiver. FDA does not anticipate many instances in 
which electronic submission of registration information will not be reasonable for the person 
requesting the waiver because the information requested is minimal and the electronic system for 
submitting the information is an internet-based system accessible to all firms seeking to register. 
However, if you are granted a waiver, you will be instructed on how to submit the required 
registration information.  
 
To apply for a waiver from the requirement to electronically submit drug establishment 
registration information, you should provide to the following address a written request with a 
complete explanation of why the use of electronic means is not reasonable for you: 
 
Drug Registration and Listing System Team 
U.S. Food and Drug Administration 
10903 New Hampshire Avenue  
Silver Spring, MD 20993-0002  
 
or  
  
Email: edrls@fda.hhs.gov  
 
D.  Registration Fees 
 
Under the DQSA, a facility is not considered registered until the facilitys registration fees 
(establishment fees) have been paid (see section 744K(g)(3)(A) of the FD&C Act).  Beginning 
                                                 
9 The list is available at 
http://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/pharmacycompounding/ucm378645.htm.  
Additional information concerning outsourcing facility registration is available at 
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm389118.htm.    
    4   
  Contains Nonbinding Recommendations 
 
in fiscal year (FY) 2015 (October 1, 2014 to September 30, 2015), facilities that elect to register 
with FDA as outsourcing facilities must pay an annual establishment fee (744K(a)(1)(A)).  For 
detailed information on annual establishment fees for outsourcing facilities, refer to the guidance 
for industry Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B 
and 744K of the FD&C Act.   
    5