What repackaging is
The regulation defines it. 21 CFR 207.1: "Repack or repackage means the act of taking a finished drug product or unfinished drug from the container in which it was placed in commercial distribution and placing it into a different container without manipulating, changing, or affecting the composition or formulation of the drug."
The FDA describes the trade in plainer terms: "Generally, repackagers take bulk API (usually in powder form) or excipients from the container in which the API or excipient was distributed by the original manufacturer and place it into a different container without further manipulation of the API or excipient, for distribution to drug manufacturers, such as compounders."
Repackaging is a registered activity. Section 510 (21 U.S.C. 360(a)(1)) counts "repackaging or otherwise changing the container, wrapper, or labeling of any drug package" within manufacture, and 21 CFR 207.21(a) sets registration "no later than 5 calendar days after beginning to manufacture, repack, relabel, or salvage a drug".
A repackaged lot therefore has two establishments behind it: the one that made the API and the one that filled the container you received. The sources below say what the COA has to name about each.
ICH Q7 section 11.4: what each certificate shows
ICH Q7 is the ICH guideline titled "Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients". It is a guideline, and the passages quoted here say "should".
The FDA points compounders to it: "The guidance for industry, Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients contains information on how API, from original manufacturers and API repackagers and relabelers, should identify the original API manufacturer to assure transparency as the API moves through the supply chain."
11.43. "Certificates should be dated and signed by authorised personnel of the quality unit(s) and should show the name, address and telephone number of the original manufacturer. Where the analysis has been carried out by a repacker or reprocessor, the Certificate of Analysis should show the name, address and telephone number of the repacker/reprocessor and a reference to the name of the original manufacturer."
11.44. "If new Certificates are issued by or on behalf of repackers/reprocessors, agents or brokers, these Certificates should show the name, address and telephone number of the laboratory that performed the analysis. They should also contain a reference to the name and address of the original manufacturer and to the original batch Certificate, a copy of which should be attached."
Sorted by who issued the certificate, the two paragraphs read like this.
| Who issued the COA | What it should show | ICH Q7 |
|---|---|---|
| The original manufacturer | A date and the signature of authorised quality unit personnel. The original manufacturer's name, address and telephone number. | 11.43 |
| A repacker or reprocessor that carried out the analysis | The repacker's or reprocessor's name, address and telephone number, and a reference to the name of the original manufacturer. | 11.43 |
| A repacker, reprocessor, agent or broker issuing a new certificate | The name, address and telephone number of the laboratory that performed the analysis. A reference to the name and address of the original manufacturer. A reference to the original batch certificate, with a copy attached. | 11.44 |
Paragraphs 11.41 and 11.42 cover what every certificate lists, such as the batch number, each test, the acceptance limits and the numerical results. Our valid certificate standard sets those fields out.
ICH Q7 section 17: traceability and transfer of information
Section 17 is addressed to the firms between the manufacturer and you. 17.10: "This section applies to any party other than the original manufacturer who may trade and/or take possession, repack, relabel, manipulate, distribute or store an API or intermediate."
17.20 opens: "Agents, brokers, traders, distributors, repackers, or relabellers should maintain complete traceability of APIs and intermediates that they distribute." It then lists the documents that "should be retained and available":
- Identity of original manufacturer
- Address of original manufacturer
- Purchase orders
- Bills of lading (transportation documentation)
- Receipt documents
- Name or designation of API or intermediate
- Manufacturer's batch number
- Transportation and distribution records
- All authentic Certificates of Analysis, including those of the original manufacturer
- Retest or expiry date
17.60. "Agents, brokers, distributors, repackers, or relabellers should transfer all quality or regulatory information received from an API or intermediate manufacturer to the customer, and from the customer to the API or intermediate manufacturer."
17.61. "The agent, broker, trader, distributor, repacker, or relabeller who supplies the API or intermediate to the customer should provide the name of the original API or intermediate manufacturer and the batch number(s) supplied."
17.63. "The specific guidance for Certificates of Analysis included in Section 11.4 should be met."
ICH's Questions and Answers on Q7 say who counts as the original manufacturer. Answer 17.4: "The original manufacturer would be the facility where the final purified API/intermediate is produced. Further physical processing (e.g., drying, micronisation, milling, sieving) of an API would not make the manufacturer performing such operations the original manufacturer."
What the FDA says about repackagers
The FDA's page for compounders on bulk and excipient suppliers has a list headed "Repackagers should". Two of its items bear on the COA.
- "clearly identify the original API manufacturer to customers who use them to make the finished drugs"
- "ensure you have sufficient supply chain transparency to mitigate risks to patients"
The FDA's January 2025 interim policy on 503A bulk drug substances is guidance and is marked nonbinding. It defines the term: "Original manufacturer means the entity that originally produced the bulk drug substance and not a subsequent packer, repacker, labeler, or distributor."
The same document lists conditions for the substances that policy covers. One reads: "The original manufacturer and all subsequent manufacturers of the bulk drug substance are establishments that are registered under section 510 (including foreign establishments that are registered under section 510(i) of the FD&C Act)".
The six peptides in HHS's policy
HHS's 2026 policy on 503A compounding with six named peptide bulk drug substances sets conditions. Condition 4 is about the original manufacturer and the repacker:
Condition 4. "The original manufacturer of the bulk drug substance (not a subsequent packer, repacker, labeler, or distributor) is registered with FDA under section 510, is in compliance with CGMP and other FD&C requirements and the physical location of the facility is listed on the COA provided to the 503A compounder. If the peptide bulk drug substance is obtained through an FDA-registered repacker, relabeler, or reseller, that entity has itself performed and documented appropriate vendor validation of the bulk drug substance manufacturer and validation of the manufacturer's COA."
Appendix B of the policy lists what the COA carries. Three of its lines concern this page:
- "Manufacturer's corporate name, its FDA Establishment Identification (FEI) number, address"
- "Repacker or reprocessor, the laboratory that performed the analysis, if applicable"
- "Dated and signed by authorized personnel of the quality unit(s) and identify the original manufacturer"
The policy is a draft, interim policy of enforcement discretion for six named peptides. It does not place them on the 503A bulks list. We go through it at HHS's peptide policy, condition by condition and set out the COA lines at Appendix B.
What we look for in a repackaged lot's file
This is our practice, built from the sources above. It is not a rule of the FDA, ICH or a board.
| What to find | Where | Rests on |
|---|---|---|
| The original manufacturer's name and address | On the COA | ICH Q7 11.43 and 11.44 |
| The original batch certificate | Attached to the repacker's certificate | ICH Q7 11.44 |
| The laboratory that performed the analysis | On the repacker's certificate | ICH Q7 11.44 |
| The manufacturer's batch number, matched to the lot number on your container | Both certificates and the label | ICH Q7 17.20 and 17.61 |
| Registration and FEI for each establishment | The FDA's registration site. See the FEI lookup guide. | 21 U.S.C. 353a(b)(1)(A)(ii); 21 CFR 207.21 |
| For the six peptides: the manufacturer's FEI and facility location on the COA, and the repacker's documented vendor validation | The COA and the supplier's documents | HHS policy, condition 4 and Appendix B |
When one of these is missing, we record the gap and ask the supplier for the document. In our vocabulary the item stays Decision owed until it arrives, and a pharmacist decides on the lot.
Sources
Every source below was opened and read for this page. Last reviewed: November 11, 2026.
- 21 CFR 207.1. Definitions for drug establishment registration and listing. Read at Cornell Law School's LII.
- 21 CFR 207.21. When an establishment registers. Read at Cornell Law School's LII.
- 21 U.S.C. 360. Section 510 of the Federal Food, Drug, and Cosmetic Act. Read at Cornell Law School's LII.
- 21 U.S.C. 353a. Section 503A of the Federal Food, Drug, and Cosmetic Act. Read at Cornell Law School's LII.
- ICH Q7, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients. ICH Harmonised Tripartite Guideline, Step 4 version dated 10 November 2000. PDF.
- ICH Q7 Questions and Answers. ICH, version dated 10 June 2015. PDF.
- FDA to Compounders: Know Your Bulks and Excipients Suppliers. The FDA. Content current as of February 4, 2026.
- Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act. The FDA, guidance for industry, January 2025. Nonbinding. PDF.
- HHS Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances. FR Doc. 2026-22192, published in the Federal Register on October 30, 2026.
ICH holds the copyright in ICH Q7 and its Questions and Answers. The passages on this page are quoted with that copyright acknowledged.
We read documents. We do not test material.