Expiration Dating of 
Unit-Dose Repackaged 
Solid Oral Dosage Form 
Drug Products 
Guidance for Industry 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
 
July 2020 
Pharmaceutical Quality/Manufacturing Standards (CGMP) 
    
Expiration Dating of 
Unit-Dose Repackaged 
Solid Oral Dosage Form 
Drug Products 
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/guidance-compliance-regulatory-information/guidances-drugs 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
 
July 2020 
Pharmaceutical Quality/Manufacturing Standards (CGMP) 
  Contains Nonbinding Recommendations 
 
TABLE OF CONTENTS 
 
 
 
I.  INTRODUCTION............................................................................................................. 1 
II.  BACKGROUND ............................................................................................................... 2 
III.  POLICY ............................................................................................................................. 2 
i  Contains Nonbinding Recommendations 
 
Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage 
Form Drug Products 
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 office responsible for this guidance as listed on the title 
page. 
 
 
 
 
I.  INTRODUCTION 
 
The last few decades have seen an increasing demand in various health care settings for solid 
oral dosage form drug products repackaged into unit-dose containers, which hold a quantity of 
drug for administration as a single dose. The increase in unit-dose repackaging has led to 
questions regarding stability studies and appropriate expiration dates for these repackaged 
products. This guidance describes the circumstances under which FDA generally does not intend 
to take action regarding required stability studies for these repackaged products and appropriate 
expiration dates under those circumstances. 
 
This guidance addresses repackaging of prescription and over-the-counter solid oral dosage form 
drugs into unit-dose containers by commercial pharmaceutical repackaging firms that are 
required to register with FDA under section 510 of the Federal Food, Drug, and Cosmetic Act 
(FD&C Act) and to comply with current good manufacturing practice (CGMP) regulations in 
21 CFR parts 210 and 211.2  
 
The guidance does not address repackaging involving the following: 
  
  Other dosage forms (e.g., liquid dosage forms3). 
                                                 
1 This guidance has been prepared by the Office of Pharmaceutical Quality in the Center for Drug Evaluation and 
Research at the Food and Drug Administration.  
2 As described in 21 CFR 207.3(a)(8), manufacturing or processing includes repackaging or otherwise changing the 
container, wrapper, or labeling of any drug package to further the distribution of the drug from the original place of 
manufacture to the person who makes final delivery or sale to the ultimate consumer. 
3 Liquid dosage forms are excluded from this guidance because they are substantially more susceptible to 
degradation than solid dosage forms. For example, their components, including active ingredients, are more likely to 
interact with each other, light, reactive gases, and the primary container-closure system. See guidance for industry 
Container Closure Systems for Packaging Human Drugs and Biologics (May 1999). We update guidances 
periodically. For the most recent version of a guidance, check the FDA guidance web page at 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents. 
  1  Contains Nonbinding Recommendations 
 
  Products repackaged by State-licensed pharmacies, Federal facilities, and outsourcing 
facilities as defined under section 503B of the FD&C Act.4 
 
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 
 
FDAs CGMP regulations for finished pharmaceuticals require that each drug product bear an 
expiration date determined by appropriate stability testing and that the date must be related to 
any storage conditions stated on the labeling, as determined by stability studies ( 211.137(a) 
and (b)).5 The expiration date for a drug product packaged in a single-dose container should be 
placed on the primary container unless it is not feasible to do so.6 
 
Samples used for stability testing must be in the same container-closure system as that in which 
the drug product is marketed ( 211.166(a)(4)). This is to ensure the drug products safety and 
efficacy over its intended shelf life and to ensure that data representing the marketed product are 
available in case quality issues arise during the drug products intended shelf life.  
 
For unit-dose repackaged products, United States Pharmacopeia (USP) General Chapter <1178> 
Good Repackaging Practices recommends that the expiration date not exceed (1) 6 months 
from the date of repackaging; or (2) the manufacturers expiration date; or (3) 25% of the time 
between the date of repackaging and the expiration date shown on the manufacturers bulk article 
container of the drug being repackaged, whichever is earlier.7  
 
 
III.  POLICY 
 
At this time and based on our current understanding of the risks involved, for solid oral dosage 
form drugs repackaged into unit-dose containers, FDA generally does not intend to take action 
regarding nonconformance with the requirements of  211.137 and 211.166 (i.e., expiration 
dating determined by stability studies) if these products are assigned, and labeled with, an 
expiration date that does not exceed (1) 6 months from the date of repackaging, or (2) 25 percent 
                                                 
4 Repackaging by state-licensed pharmacies, Federal facilities, and outsourcing facilities is addressed by separate 
guidance. See, for example, guidance for industry Repackaging of Certain Human Drug Products by Pharmacies 
and Outsourcing Facilities (January 2017). 
5 Expiration dating requirements are in  211.137, which exempts certain drugs (homeopathic and some over-the-
counter drugs) from bearing an expiration date on the label. Stability testing and stability studies are described in 
 211.166. 
6 Under 21 CFR 201.17, when single-dose containers are packed in individual cartons, the expiration date may 
properly appear on the individual carton instead of the immediate product container. 
7 Here and elsewhere in this guidance, the USP version referenced is USP 42-NF 37 (NF=National Formulary). 
  2  Contains Nonbinding Recommendations 
 
of the time between the date of repackaging and the expiration date on the container of the 
original manufacturers product, whichever time period is shorter, and if all the following 
circumstances are present: 
 
(1) The unit-dose container complies with Class A or Class B standards as described in USP 
General Chapter <671> ContainersPerformance Testing. 
 
Repackagers should use containers complying with the Class B standard only if (a) 
appropriate data on the moisture permeability of the Class B material and the moisture 
sensitivity of the drug product are available, and (b) a risk assessment of these data 
provides them with a high level of confidence that use of such containers will not 
compromise the quality of the product throughout the assigned expiration dating.8 
 
(2) If the drug product is sensitive to light as indicated by the manufacturer (e.g., Protect 
from light on its labeling), the unit-dose repackaging container-closure system provides 
light protection equal to or greater than that of the drug products original container-
closure system. 
 
(3) The drug products original container has not been opened previously and the entire 
contents are repackaged in one operation. 
 
(4) Repackaging and storage occur in an environment that is consistent with the conditions 
described in the original drug products labeling. If temperature and humidity are not 
specified in the original labeling, the product should be maintained at controlled room 
temperature and in a dry place (as defined in USP <659> Packaging and Storage 
Requirements) during the repackaging process, including storage. 
 
(5) The drug products labeling does not caution against repackaging.9  
 
In addition, FDA generally does not intend to take action regarding nonconformance with the 
requirements of  211.137 and 211.166 for an expiration date exceeding the ones described 
above (i.e., (1) 6 months from the date of repackaging, or (2) 25 percent of the time between the 
date of repackaging and the expiration date on the container of the original manufacturers 
product, whichever time period is shorter), provided that: 
 
(1) The above five circumstances are present. 
 
(2) Supportive data from appropriate studies, using an adequate number of samples, 
demonstrate that the container-closure system used for repackaging is at least as 
protective of the drug product as is the original packaging. Appropriate studies must be 
                                                 
8 Containers meeting USP <671> Class C and Class D standards do not fit the circumstances described in (1).  
9 Directions in the package insert such as Keep these tablets in the original container and Do not repackage are 
examples of a caution against repackaging in the products labeling. 
  3  Contains Nonbinding Recommendations 
 
based on sound science10 and should be supported by a risk-based assessment to ensure 
that product quality is maintained up to the expiration date.11 
 
(3) The expiration date of the repackaged product does not exceed the original 
manufacturers expiration date. 
                                                 
10 21 CFR 211.166(a) requires that sample size and approach be statistically based and reliable, meaningful, and 
specific test methods be used for stability testing; and  211.160(a) and (b) require scientifically sound and 
appropriate test methods and sampling plans, among other requirements. 
11 Satisfactory comparison of container-closure systems is possible through several methods, e.g., testing for 
protection from moisture, oxygen, and light, as appropriate; comparing the properties of the original container-
closure system to a new system by stress testing, which refers to product testing after storage under exaggerated 
conditions (e.g., high temperature and high humidity); degradation testing after storage under long-term or 
accelerated conditions. Approaches such as those described in ICH guidance for industry Q1A(R2) Stability Testing 
of New Drug Substances and Products (November 2003) (e.g., bracketing or matrixing) may be used, if justified. 
  4