Drugs

FDA Compounding Documents and Actions

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The following table describes some of the documents and actions involved in FDA oversight of compounding facilities:

Documents and ActionsDescription
RecallCompounders may initiate a recall at any time to fulfill their responsibility to protect the public health from products that present a risk of injury or gross deception, or are otherwise defective. Compounders may also initiate a recall and cease operations, where appropriate, following notification of a problem by FDA or a state agency or in response to a formal request by FDA. For more information about FDA’s regulatory policies related to recalls, see Regulatory Procedures Manual Chapter 7.
Form FDA-483A Form FDA-483 lists observations made by FDA investigators during an inspection. These are inspectional observations and do not represent a final agency determination regarding compliance.
Establishment Inspection ReportFollowing an inspection, the Investigator prepares a report of findings during the inspection, which is referred to as the establishment inspection report, or EIR. Following an inspection, if no enforcement action is contemplated, or after enforcement action is concluded and the inspection is considered “closed” under 21 CFR §20.64(d)(3), FDA provides establishments with a copy of the final EIR. See Field Management Directive 145.
FMD-145According to Field Management Directive 145, FDA issues a copy of the narrative portion of the EIR to the compounder once the agency has determined that a surveillance inspection is closed.
Warning LetterFDA issues warning letters when there are violations of regulatory significance to give compounders an opportunity to take voluntary and prompt action to correct violations of the law before the agency initiates an enforcement action. However, FDA is under no legal obligation to warn compounders that they or their products are in violation of the law before taking enforcement action. In some cases, FDA might pursue an enforcement action to protect the public health without first issuing a warning letter. See Regulatory Procedures Manual Chapter 4.
Untitled LetterAn untitled letter cites violations that do not meet the threshold for significance of regulatory significance for a warning letter. See Regulatory Procedures Manual Chapter 4.
Warning Letter Close-out LetterFDA issues a warning letter close-out letter if FDA verifies that the compounder has adequately addressed the violations in the warning letter, provided that certain conditions are met. SeeRegulatory Procedures Manual Chapter 4.
Warning Letter ResponseWritten notification, submitted by the compounder within 15 working days of receipt of a warning letter, describing specific steps the compounder intends to take to correct violations. When a compounder who received a warning letter requests that FDA post the warning letter response and provides the response electronically in a word processing format, the agency will post that response. The agency has reserved the right not to post certain responses, such as when posting likely would mislead the public about the safety or efficacy of a regulated product. See Regulatory Procedures Manual Chapter 4.
Inspection WarrantInspection warrants may be sought when inspection has been refused completely or when refusals have been encountered in limited areas; for example, when photography or sample collection has been refused.  See Regulatory Procedures Manual Chapter 6.
SeizureA seizure is an action initiated to seize (take possession or place in constructive custody of the court) articles, such as drugs, where the government asks the court to condemn the articles and declare forfeiture for violations of the law.
See Regulatory Procedures Manual Chapter 6.
InjunctionAn injunction is a civil judicial process initiated to stop or prevent violation of the law, such as to halt the flow of violative products in interstate commerce, and to correct the conditions that caused the violation to occur. See Regulatory Procedures Manual Chapter 6.
Regulatory MeetingA regulatory meeting is a meeting requested by FDA to inform responsible individuals or compounders about how one or more products, practices, processes, or other activities are considered to be in violation of the law. See Regulatory Procedures Manual Chapter 10.

 

Page Last Updated: 10/31/2018
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