Compounded Drug Products That 
Are Essentially Copies of a 
Commercially Available Drug 
Product Under Section 503A of 
the Federal Food, Drug, and 
Cosmetic Act 
 
Guidance for Industry 

 
 
 
 
 
 
 
U.S. Department of Health and Human Services 

Food and Drug Administration 

Center for Drug Evaluation and Research (CDER)
  
Office of Compliance/OUDLC 

 
January 2018 

Compounding 

 
   
  Compounded Drug Products That 
Are Essentially Copies of a 
Commercially Available Drug 
Product Under Section 503A of 
the Federal Food, Drug, and 
Cosmetic Act 
 
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)
  
Office of Compliance/OUDLC 

 
January 2018 

Compounding 
 Contains Nonbinding Recommendations 
 
TABLE OF CONTENTS  
 
 
 
I.   INTRODUCTION AND SCOPE........................................................................................ 1 
 
II.   BACKGROUND .................................................................................................................. 2
  
A.   Section 503A of the FD&C Act ........................................................................................................ 2
  
B.   Compounding, Generally ................................................................................................................. 2
  
C.   Risks Associated with Compounded Drug Products...................................................................... 3 
 
D.   Compounded Drugs That Are Essentially Copies of Commercially Available Drug Products . 3
  
III.   POLICY............................................................................................................................. 4
  
A.   Commercially Available Drug Product ........................................................................................... 5 
 
B.   Essentially a Copy of a Commercially Available Drug Product ................................................... 5
  
IV. PAPERWORK REDUCTION ACT................................................................................... 11 
 
APPENDIX A. ............................................................................................................................. 12
   Contains Nonbinding Recommendations 
 
Compounded Drug Products That Are Essentially Copies of a 

Commercially Available Drug Product Under Section 503A of the 

Federal Food, Drug, and Cosmetic Act 

Guidance for Industry1
  
 
 
 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA or the Agency) 
on this topic.  It does not create any rights for any person and is not binding on FDA or the public.  You 
can use an alternative approach if the approach satisfies the requirements of the applicable statutes and 
regulations. To discuss an alternative approach, contact the FDA office responsible for this guidance as 
listed in the title page.   
 
 
 
I.  INTRODUCTION AND SCOPE  
 
To qualify for exemptions under section 503A of the Federal Food, Drug, and Cosmetic Act 
(FD&C Act), a drug product must be compounded by a licensed pharmacist or physician who 
does not compound regularly or in inordinate amounts any drug products that are essentially 
copies of a commercially available drug product, among other conditions.  This guidance sets 
forth FDAs policies regarding this provision of section 503A, including the terms commercially 
available, essentially a copy of a commercially available drug product, and regularly or in 
inordinate amounts.2   
 
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. 
 
                                                 
1  This guidance has been prepared by  multiple offices in the Center for Drug Evaluation and Research, in  
consultation with the Office of Regulatory Affairs at the Food and Drug Administration.  
2 This  guidance does not apply to drugs compounded for use in animals, to biological  products subject to  licensure  
in a biologics license application, or to repackaged  drug  products.  For policies pertaining  to mixing, diluting, and 
repackaging  biological products, see FDAs guidance, Mixing, Diluting,  and Repackaging Biological Products  
Outside the Scope of  an Approved Biologics License Application.   For policies pertaining to repackaged  drug  
products,  see FDAs guidance, Repackaging  of Certain Human Drug Products by Pharmacies and  Outsourcing  
Facilities.  
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 
 
II.  BACKGROUND 
 
A.   Section 503A of the FD&C Act 
 
Section 503A, added to the FD&C Act by the Food and Drug Administration Modernization Act 
of 1997 and amended by the Drug Quality and Security Act in 2013, describes the conditions 
that must be satisfied for human 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  
the following three sections of the FD&C Act:3  
  
   Section 501(a)(2)(B) (concerning current good manufacturing practice (CGMP) 
requirements)  
   Section 502(f)(1) (concerning the labeling of drugs with adequate directions for use) 
   Section 505 (concerning the approval of drugs under new drug applications (NDAs) or 
abbreviated new drug applications (ANDAs))   
 
One of the conditions that must be met for a compounded drug product to qualify for the 
exemptions under section 503A of the FD&C Act is that it must be compounded by a licensed 
pharmacist or a licensed physician that does not compound regularly or in inordinate amounts 
(as defined by the Secretary) any drug products that are essentially copies of a commercially 
available drug product.4   
 
The statute further states that the term essentially a copy of a commercially available drug 
product does not include a drug product in which there is a change, made for an identified 
individual patient, which produces for that patient a significant difference, as determined by the 
prescribing practitioner, between the compounded drug and the comparable commercially 
available drug.5  
 
A complete list of the conditions that must be met for a compounded drug product to qualify for 
the exemptions in section 503A appears in the FDA guidance, Pharmacy Compounding of 
Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act. 
 
B.   Compounding, Generally 
 
Compounded drug products serve an important role for patients whose clinical needs cannot be 
met by an FDA-approved drug product, such as a patient who has an allergy and needs a 
medication to be made without a certain dye, an elderly patient who cannot swallow a pill and 
needs a medicine in a liquid form that is not otherwise available, or a child who needs a drug in a 
strength that is lower than that of the commercially available product.  Drug products for 
identified individual patients can be compounded by licensed pharmacists in state-licensed 
                                                 
3 In addition, under section 581(13) of the FD&C Act, the term product, for purposes of pharmaceutical supply 
chain security requirements, does not include a drug compounded in compliance with section  503A. 
4 See section 503A(b)(1)(D). 
5 See section 503A(b)(2). 
 
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       Contains Nonbinding Recommendations 
 
pharmacies and Federal facilities and by licensed physicians operating under section 503A of the 
FD&C Act. Drug products can also be compounded by outsourcing facilities under section 503B 
of the FD&C Act for identified individual patients pursuant to prescriptions or for distribution to 
health care practitioners without first receiving a prescription.6  Both sections 503A and 503B 
restrict compounding drug products that are essentially a copy of a commercially available drug 
product (section 503A) or an approved drug product (section 503B). 
 
C.   Risks Associated with Compounded Drug Products 
 
Although compounded drugs can serve an important need, they can also pose a higher risk to 
patients than FDA-approved drugs.  Compounded drug products are not FDA-approved, which 
means they have not undergone FDA premarket review for safety, effectiveness, and quality.  In 
addition, licensed pharmacists and licensed physicians who compound drug products in 
accordance with section 503A are not required to comply with CGMP requirements.   
Furthermore, FDA does not interact with the vast majority of licensed pharmacists and licensed 
physicians who compound drug products and seek to qualify for the exemptions under section 
503A of the FD&C Act for the drug products that they compound because these compounders 
are not licensed by FDA and generally do not register their compounding facilities with FDA.  
Therefore, FDA is often not aware of potential problems with their compounded drug products 
or compounding practices unless it receives a complaint, such as a report of a serious adverse 
event or visible contamination.   
  
FDA has investigated numerous serious adverse events associated with compounded drug 
products that were contaminated or otherwise compounded improperly, including the adverse 
events associated with the 2012 fungal meningitis outbreak in which contaminated injectable 
drug products resulted in more than 60 deaths and 750 cases of infection.  FDA has also 
identified many pharmacies that compounded drug products under insanitary conditions such 
that the drug products may have been contaminated with filth or rendered injurious to health and 
that shipped the compounded drug products made under these conditions to patients and health 
care practitioners across the country, sometimes in large amounts.    
 
D.   Compounded Drugs That Are Essentially Copies of Commercially Available 
Drug Products 
 
Section 503A provides exemptions from new drug approval, labeling with adequate directions 
for use, and CGMP requirements of the FD&C Act, so that drug products can be compounded as 
customized therapies for identified individual patients whose medical needs cannot be met by 
commercially available drug products. The restrictions on making drugs that are essentially 
copies ensure that pharmacists and physicians do not compound drug products under the 
exemptions for patients who could use a commercially available drug product. Such a practice 
would create significant public health risks because patients would be unnecessarily exposed to 
drug products that have not been shown to be safe and effective and that may have been prepared 
                                                 
6 Section 503B of the FD&C Act describes the conditions that must be met for a human drug product compounded 
by an outsourcing  facility to qualify for exemptions  from  sections 505, 502(f)(1), and 582 (concerning drug  supply 
chain security requirements) of  the FD&C Act.  The conditions applicable to  outsourcing  facilities are discussed in  
separate guidances applicable to those facilities.  
3
       Contains Nonbinding Recommendations 
 
under substandard manufacturing conditions.  FDA has investigated serious adverse events in 
patients who received contaminated compounded drugs when a comparable approved drug, made 
in a facility subject to CGMP requirements, was available. 
 
In addition to these immediate public health risks, section 503As limitations on producing a 
drug product that is essentially a copy of a commercially available drug product protects the 
integrity and effectiveness of the new drug and abbreviated new drug approval processes that 
Congress put in place to protect patients from  unsafe, ineffective, or poor quality drugs.   
Furthermore, sponsors may be less likely to invest in and seek approval of innovative, life-saving 
medications if a compounder could, after a drug is approved, compound substitutes that may 
be less expensive because they have not had to demonstrate safety and effectiveness and are not 
produced in accordance with CGMP requirements or labeled with adequate directions for use.  
 
Sponsors might also be less likely to seek approval of an ANDA for a generic drug if  
compounders were permitted to compound drugs that are essentially copies of commercially 
available drugs without going through the ANDA process.  An ANDA must include data to 
demonstrate that the drug has the same active ingredient and is bioequivalent to an approved 
drug.  FDA also conducts premarketing inspections of proposed manufacturing facilities.    
 
The copies restriction also protects FDAs drug monograph process. FDA has an ongoing 
process for evaluating the safety and effectiveness of certain over-the-counter (OTC) 
medications, and if the Agency determines that an OTC drug meets certain conditions and is 
generally recognized as safe and effective, it will publish a final monograph specifying those 
conditions. Products that comply with a final monograph may be marketed, but manufacturers 
are required to meet CGMP standards. Restrictions in section 503A prevent compounders from  
producing drugs without having to comply with monograph standards, or CGMP requirements.       
 
III.  POLICY  
 
As stated above, to qualify for the exemptions under section 503A of the FD&C Act, a drug must 
be compounded by a licensed pharmacist or a licensed physician that does not compound 
regularly or in inordinate amounts (as defined by the Secretary) any drug products that are 
essentially copies of a commercially available drug product.7  This means that a compounded 
drug product is not eligible for the exemptions in section 503A if it is (1) essentially a copy of a 
commercially available drug product, and (2) compounded regularly or in inordinate amounts.  
Accordingly, and as discussed below, when evaluating whether a drug product meets the 
condition in section 503A regarding essentially copies, FDA intends to determine whether a 
compounded drug product is essentially a copy of a commercially available drug product: if it is,  
FDA intends to determine whether the drug product was compounded regularly or in inordinate 
amounts.8  
                                                 
7 See section 503A(b)(1)(D). 
8 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 or rulemaking. FDA regards a health system as collection  of  
hospitals that are owned and operated  by the same entity and that share access to databases with drug order 
information for their patients. There is no definition  of health system that applies to all sections  of the FD&C Act. 
 
4
       Contains Nonbinding Recommendations 
 
 
FDAs policies with regard to the terms (1) commercially available drug product, (2) essentially 
a copy of a commercially available drug product, and (3) regularly or in inordinate amounts, are 
as follows: 
 
A.   Commercially Available Drug Product 
 
For purposes of this guidance, a drug product is commercially available if it is a marketed drug 
product. 
 
We do not consider a drug product to be commercially available if  
 
 	  the drug product has been discontinued and is no longer marketed9 or 
 
 	  the drug product appears on the FDA drug shortage list in effect under section 506E 
of the FD&C Act.10  A drug appears on the drug shortage list in effect under section 
506E if the drug is in currently in shortage status (and not in resolved status) in 
FDAs drug shortage database. 
 
Commercially available drugs are available on the market, and they are generally subject to 
FD&C Act requirements relating to approval, labeling, and CGMP requirements, and the copies 
restriction applies to all such drugs because section 503A is not intended to provide a means for 
compounders to produce compounded drugs exempt from the Acts requirements that are 
essentially copies of commercially available drug products. 
 
B.   Essentially a Copy of a Commercially Available Drug Product 
 
1. 	  What is Essentially a Copy? 
 
FDA intends to consider a compounded drug product to be essentially a copy of a commercially 
available drug product if: 
 
   the compounded drug product has the same active pharmaceutical ingredient(s) (API) as 
the commercially available drug product;  
   the API(s) have the same, similar, or an easily substitutable dosage strength; and  
                                                 
However, this is the definition of a health system used in section  506F of the Act concerning  hospital repackaging  
of drugs in shortage.  
9 FDA maintains a list of approved drug  products that sponsors have indicated are not marketed in the discontinued 
section of the list of Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). See  
http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm. Specifically, the list includes approved drug products 
that have never been marketed, are for exportation, are for military use, have been discontinued from marketing and 
we have  not determined were withdrawn for safety or effectiveness reasons, or have had their approvals  withdrawn  
for reasons other than safety or effectiveness subsequent to  being discontinued from  marketing.    
10 See http://www.accessdata.fda.gov/scripts/drugshortages/default.cfm.  
5
       Contains Nonbinding Recommendations 
 
 	  the commercially available drug product can be used by the same route of administration 
as prescribed for the compounded drug, 
 
unless, as provided by section 503A(b)(2), a prescriber determines that there is a change, made 
for an identified individual patient, which produces, for that patient, a significant difference from  
the commercially available drug product.  
 
The limitations in section 503A(b)(1)(D) apply to the compounding of drug products that are 
essentially copies of a commercially available drug product  not only to drugs that are exact 
copies or even to drugs that are nearly identical. This is to ensure that compounders do not evade 
the limits in this section by making relatively small changes to a compounded drug product and 
then offering the drug to the general public without regard to whether a prescribing practitioner 
has determined that the change produces for the patient a significant difference.  For example, 
Congress contemplated that a compounded drug may be essentially a copy of a commercially 
available drug if minor changes in strength (such as from .08% to .09%) are made that are not 
known to be significant . . . for the patient for whom the drug was prescribed.11  
 
a. 	  Same API  
 
With regard to the characteristics listed above, an API is the substance in a drug product that is 
intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, 
mitigation, treatment, or prevention of disease or to affect the structure or function of the body.12   
When a compounded drug product offers the same API as a commercially available drug 
product, in the same, similar, or easily substitutable dosage strength and for use through the same  
route of administration, we generally intend to consider such a drug product essentially a copy,  
unless a prescriber determines that there is a change, made for an identified individual patient, 
that will produce a significant difference for that patient.  
 
We recognize that, for some patients, a drug product that has the same API, strength, and route 
of administration may include a change that produces a significant difference for a particular 
patient. For example, a drug product compounded without a particular inactive ingredient may 
produce a significant difference for a patient who has an allergy to the inactive ingredient in the 
commercially available drug product. However, for other patients, this change may produce no 
difference at all. Congress did not intend for compounders to use, for example, the fact that some  
patients may have allergies as a basis to compound a drug without the inactive ingredient for 
other patients who do not have the allergy under the exemptions in section 503A (i.e., without 
meeting requirements for premarket approval, labeling with adequate directions for use, or 
                                                 
11 U.S. House. Food and  Drug  Administration Modernization Act of 1997, Conference Report (to Accompany S. 
830). (105 H. Rpt. 399). 
12 Section 503A refers to bulk drug substances.  A bulk drug  substance is defined as any substance that is intended 
for incorporation into a finished drug  product and is intended to furnish pharmacological activity or other direct  
effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function 
of the body. It  does not include intermediates used in the synthesis of the substance. This  definition is the same as 
the definition of active pharmaceutical ingredient. See 21 CFR 207.1, 207.3.  
 
6
       Contains Nonbinding Recommendations 
 
CGMP requirements).13  In the context of compounding and consistent with the statute, we 
generally intend to consider such a drug essentially a copy unless a prescriber determines that 
there is a change that will produce a significant difference for the patient for whom it is 
prescribed. 
 
b.   Same, Similar or Easily Substitutable Strength  
 
FDA generally intends to consider two drugs to have a similar dosage strength if the dosage 
strength of the compounded drug is within 10% of the dosage strength of the commercially 
available drug product. 
 
With regard to the concept of easily substitutable strength, in some cases, the same or similar 
dosage strength can be achieved by administration of fractional or multiple doses of a drug 
product. For example, if FDA-approved Drug X tablets have a dosage strength of 25 mg and a 
patient needs 50 mg of Drug X, FDA would generally consider a compounded Drug X 50 mg  
tablet to have an easily substitutable strength because the patient could take two Drug X 25 mg  
tablets to achieve the required dose.14   
 
c.   Same Route of Administration 
 
Route of administration is a way of administering a drug to a site in a patient (e.g., topical, 
intravenous, oral).15  In general, FDA does not intend to consider a compounded drug product 
with the same API and similar or easily substitutable strength to be essentially a copy of a 
commercially available drug product if the compounded drug product and the commercially 
available drug product have different routes of administration (e.g., if the commercially available 
drug product is oral and the compounded drug product is topical).  However, if the compounded 
drug product has the same API and similar or easily substitutable strength as the commercially 
available drug product and the commercially available drug product can be used (regardless of 
how it is labeled) by the route of administration prescribed for the compounded drug, FDA 
generally intends to consider the compounded drug to be essentially a copy of the commercially 
available drug. In this case, the compounded drug product generally would not produce a 
significant difference for an identified individual patient relative to the commercially available 
drug product. 
 
For example, if the commercially available drug is an injectable drug sold in a vial that is labeled 
for intra-muscular use, but the drug also can be drawn from the vial by a smaller needle for 
subcutaneous administration, a compounded drug product with the same API and similar or 
                                                 
13  See note 11. 
14 If a commercially available tablet must be split to achieve the prescribed  dosage strength, and such tablet is not  
suitable for splitting, FDA would  not consider the compounded drug made to the prescribed  dosage strength to have  
an easily substitutable strength. For example, some tablets may be too small or crumble too easily when split, 
making  splitting an inappropriate option. Information regarding tablet splitting may be printed in the HOW 
SUPPLIED section  of the professional label insert and in  the patient package insert of an approved drug product. 
15 See 
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/D 
ataStandardsManualmonographs/ucm071667.htm.   
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       Contains Nonbinding Recommendations 
 
easily substitutable strength prescribed for sub-cutaneous administration would generally be 
considered to be essentially a copy, unless the prescriber documents on the prescription that the 
compounded drug product produces a significant difference for the identified individual patient.  
 
d.   Same Characteristics as Two or More Commercially Available Drug Products 
 
FDA intends to consider a compounded drug product to be essentially a copy of a commercially 
available drug product if the compounded drug product contains the same APIs as two or more 
commercially available drug products in the same, similar, or easily substitutable strength and if 
the commercially available drug products can be  used (regardless of how they are labeled) by the 
same route of administration prescribed for the compounded drug, unless there is documentation 
as described in section III.B.2. Such drug products present the same kinds of concerns as drug 
products that have a single API and in some  respects may be more dangerous because of the 
potential for unintended drug interactions or formulation issues.  For example, if drug X and 
drug Y are commercially available oral drug products, FDA generally intends to consider a 
compounded oral drug product that combines drug X and drug Y in strengths that are within 10% 
of the strengths of the respective commercially available products to be essentially a copy of the 
commercially available drug product, unless a prescriber determination of a significant 
difference has been documented.  
 
2.   Statement of Significant Difference  
 
Pursuant to section 503A(b)(2) of the FD&C Act, a compounded drug product is not essentially a 
copy of a commercially available drug product if a change is made for an identified individual 
patient, and the prescribing practitioner has determined that the change will produce a significant 
difference for that patient. If a compounder intends to rely on such a determination to establish 
that a compounded drug is not essentially a copy of a commercially available drug product, the 
compounder should ensure that the determination is documented on the prescription.   
 
FDA does not believe that a particular format is needed to document the determination, provided 
that the prescription makes clear that the prescriber identified the relevant change and the 
significant difference that the change will produce for the patient.  For example, the following 
would be sufficient: 
 
   No Dye X, patient allergy (if the comparable drug contains the dye) 
   Liquid form, patient cant swallow tablet (if the comparable drug is a tablet) 
   6 mg, patient needs higher dose (if the comparable drug is only available in 5 mg dose) 
 
However, if a prescription identifies only a patient name and drug product formulation, this 
would not be sufficient to establish that the prescriber made the determination described by 
section 503A(b)(2). Note also that the significant benefit that the prescriber identifies must be 
produced by the change the compounder will make to a commercially available drug product 
(i.e., a change in drug product formulation). Other factors, such as a lower price, are not 
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       Contains Nonbinding Recommendations 
 
sufficient to establish that the compounded drug product is not essentially a copy of the 
commercially available drug product.16  
 
If a prescription does not make clear that the prescriber made the determination required by 
section 503A(b)(2), or a compounded drug is substituted for the commercially available drug 
product, the compounder can contact the prescriber and if the prescriber confirms it, make a 
notation on the prescription that the compounded drug product contains a change that makes a 
significant difference for the patient. The notations should be as specific as those described 
above, and the date of the conversation with the prescriber should be included on the 
prescription.17    
 
It is not possible to offer exhaustive guidance about when a difference will be significant to an 
identified individual patient. At this time, FDA generally does not intend to question prescriber 
determinations that are documented in a prescription or notation.  However, we do intend to 
consider whether a prescription or notation relied upon by a compounder to establish that a drug 
is not essentially a copy documents that the determination was made.  
 
If the compounder produces drugs in anticipation of receiving valid prescriptions for identified 
individual patients, and the compounder obtains the statement of significant difference from the 
prescriber when it receives the prescription for the compounded drug, prior to distribution, FDA 
does not intend to consider the compounded drug that is then distributed to be essentially a copy. 
 
 
3.   Documentation of Shortage 
 
If the drug was compounded because the approved drug product was not commercially available 
because it was on the FDA drug shortage list, the prescriber or compounder should include a 
notation on the prescription that it was on the drug shortage list and the date the list was 
checked.18    
 
4.   Regularly or in Inordinate Amounts 
 
A drug product is not eligible for the exemptions in section 503A if it is prepared by a 
pharmacist or physician who compounds regularly or in inordinate amounts (as defined by the 
Secretary) any drug products that are essentially copies of a commercially available drug 
                                                 
16 Congress noted that where it is readily apparent, based  on the circumstances, that the significant difference is a 
mere pretext to allow compounding of  products that are essentially copies of commercially available products, such  
compounding  would be considered copying  of commercially available products and would not  qualify for the 
compounding  exemptions if it is done regularly or in inordinate amounts.   Such circumstances may include, for 
example, instances in  which minor changes  in strength (such as from .08% to  .09%) are made that are not  known to  
be significant or instances in which the  prescribing physician is receiving financial remuneration or other financial 
incentives to  write prescriptions for compounded  products.  See  the U.S. House. Food and Drug Administration 
Modernization Act of 1997, Conference Report  (to Accompany S. 830). (105 H.  Rpt. 399).  
17 See section  IV of this guidance. 
18 See section  IV of this guidance. 
 
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       Contains Nonbinding Recommendations 
 
product.19  FDA interprets this to mean that, in order to be compounded in accordance with 
section 503A, a drug product that is essentially a copy of a commercially available drug product 
cannot be compounded regularly  i.e., it cannot be compounded at regular times or intervals, 
usually, or very often. Nor can the amounts compounded be inordinate, in light of the purpose of 
section 503A. 
 
Section 503A is intended to protect patients from the public health risks of providing 
compounded drugs to patients whose medical needs could be met by commercially available 
drug products and to protect the integrity and efficiency of the drug approval process.  Under the 
statutory scheme, only very rarely should a compounded drug product that is essentially a copy 
of a commercially available drug product be offered to a patient.  We conclude, therefore, that a 
drug product that is essentially a copy of a commercially available drug product is compounded 
regularly or in inordinate amounts if it is compounded more frequently than needed to address 
unanticipated, emergency circumstances, or in more than the small quantities needed to address 
unanticipated, emergency circumstances.  
 
It is important to note that the regularly or in inordinate amounts provision is not implicated if 
the compounded drug is not essentially a copy of a commercially available drug product.  For 
example, a compounded drug product that has the same API, dosage strength, and route of 
administration as a drug product on FDAs shortage list would not be considered essentially a 
copy of a commercially available drug because a drug product is not considered commercially 
available if it is on FDAs drug shortage list.  In addition, a compounded drug product is not 
essentially a copy of a commercially available drug product if a prescriber has determined that 
the compounded drug has a change that produces a significant difference for a patient.  
Once it has been determined that a compounded drug is essentially a copy of a commercially 
available drug product as described above, the following are examples of factors that may be the 
basis for concluding that it has been compounded regularly or in inordinate amounts:  
 
   The compounded drug product amounts to more than a small number of prescriptions or a 
small percentage of the compounded drug products that a compounder prepares.  
   The compounder routinely substitutes compounded drugs that are essentially copies of 
commercially available drugs upon receiving prescriptions for patients. 
   The compounder offers pre-printed prescription pads that a prescriber can use to write a 
prescription for the drug product that is essentially a copy without making a 
determination that there is a change that will produce a significant difference for a 
patient. 
   The compounded drug product is not compounded on an as-needed basis, but on a routine 
or pre-set schedule. 
 
The foregoing list is not intended to be exhaustive. Other factors may be appropriate for 
consideration in a particular case. 
 
To focus enforcement on the most significant cases, as a matter of policy, at this time FDA does 
not intend to take action against a compounder for compounding a drug product that is 
                                                 
19  See section 503A(b)(1)(D).  
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       Contains Nonbinding Recommendations 
 
essentially a copy of a commercially available drug product regularly or in inordinate amounts if 
the compounder fills four or fewer prescriptions for the relevant compounded drug product in a 
calendar month.20  As noted above, a compounded drug product is not essentially a copy of a 
commercially available drug product if a prescriber has determined that the compounded drug 
has a change that produces a significant difference for a patient; thus, a prescription that 
documents such a prescriber determination would not be counted towards the four prescriptions. 
 
Compounders may produce a limited amount of drugs in anticipation of receiving valid 
prescriptions for identified individual patients. See section 503A(a)(2). FDA generally intends to 
consider whether such drugs are essentially a copy at the time the drug is distributed rather than 
the time it is produced.  
 
5.   Recordkeeping 
 
A licensed pharmacist or physician seeking to compound a drug product under section 503A 
should maintain records to demonstrate compliance with section 503A(b)(1)(D).  For example, 
records should be kept of notations on prescriptions for identified individual patients that a 
prescriber has determined that the compounded drug has a change that produces a significant 
difference for the identified patient. 
 
Compounders under section 503A should also maintain records of the frequency in which they 
have compounded drug products that are essentially copies of commercially available drug 
products and the number of prescriptions that they have filled for compounded drug products that 
are essentially copies of commercially available drug products to document that such 
compounding has not been done regularly or in inordinate amounts.21    
 
FDA recommends that compounders maintain the records described above for a period of at least 
three years.  
 
IV.  PAPERWORK REDUCTION ACT 
 
This guidance contains information collection provisions that are subject to review by the Office 
of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 
3501-3520). See footnotes 17, 18, and 21. These provisions require review and are not in effect 
until they display a currently valid OMB control number.  The information collection provisions 
in this guidance have been submitted to OMB for review as required by section 3507(d) of the 
Paperwork Reduction Act of 1995. FDA will publish a notice in the Federal Register  
announcing OMBs decision regarding the information collection provisions in this guidance.  
 
   
                                                 
20 For purposes of this policy, FDA intends to consider each  refill of a prescription as an additional prescription.    
21 See section  IV of this guidance. 
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       Contains Nonbinding Recommendations 
 
 
APPENDIX A. 
 
 
 
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