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Compliance References
Regulatory Procedures Manual 2008
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     5-1-1 - Purpose
     5-1-2 - Legal Authority
     5-1-3 - Citation Under Multiple Laws
     5-1-4 - Criteria For Citation
     5-1-5 - Determining the Need for Citation
     5-1-6 - Time Frames
     5-1-7 - Field Office Citation Procedures
     5-1-8 - Determination Of Citees
     5-1-9 - Setting Date For Meeting
     5-1-10 - Preparation Of Citation Documents
     5-1-11 - Distribution of Citation Documents
     5-1-12 - Transfer of Meeting
     5-1-13 - Correspondence with Attorneys
     5-1-14 - Drug Advertising Citations


5-1-1 - Purpose

This section describes the Food and Drug Administration's (FDA) procedures for issuing Section 305 Notices (Citations).

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5-1-2 - Legal Authority

FDA issues Citations under Section 305 of the Federal Food, Drug, and Cosmetic Act (the Act), which states:

"Before any violation of this Act is reported by the Secretary to any United States attorney for institution of a criminal proceeding, the person against whom such proceeding is contemplated shall be given appropriate notice and an opportunity to present his views, either orally or in writing, with regard to such contemplated proceeding."

21 CFR 7.84 provides requirements about the issuance of such notice and opportunity.

NOTE: Citation is to be used only when a prosecution recommendation is contemplated. Do not use a Citation for warning purposes.

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5-1-3 - Citation Under Multiple Laws

On occasion, the same or related conduct that violates the Act may also constitute a violation of one or more other federal laws, such as the licensing provisions for biologics under the Public Health Service Act (42 U.S.C. Section 262), 18 U.S.C. Section 1001 (Fraud and False Statements), and 18 U.S.C. Section 371 (Conspiracy to commit offense or to defraud United States).

In such a case, identify the section of each law under which action is contemplated, and the specific actions considered to violate that law.

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5-1-4 - Criteria For Citation

The basic criteria for consideration of citation are as follows:

A violation of the law has been established and the agency has evidence in its possession to support the case in court.

The violation is significant in terms of consumer protection.

Except in cases involving a health hazard, fraud, or extremely gross violations, prior warning must have been given to the firm and each individual involved. This prior warning may be in the form of conferences, previous meetings, letters or discussions of FDA 483s at the conclusion of inspections or previous court actions. See Chapter 10 for a discussion of Prior Notice. In instances where the prior warning was in the form of letters or a Section 305 Notice involving past violations, copies must have been directed to each individual to be cited. NOTE: Additional, more specific criteria in many areas may be found in Compliance Policy Guides (CPG) and the Compliance Program Guidance Manual (CPGM).

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5-1-5 - Determining the Need for Citation

The district compliance branch is responsible for deciding whether citation is warranted. The compliance officer assigned to the case should ensure that all samples and other evidence have been considered. The search for other samples and evidence may include:

  1. Searching the Field Accomplishments and Compliance Tracking System (FACTS) for further information on the firm;
  2. Checking with the laboratory to find out if there are other samples that are in-process and need to be analyzed;
  3. Checking the collection report (C/R) on the initial sample to ensure that all related samples are attached; and,
  4. Checking outstanding sample assignments in FACTS.

If there are other samples to be analyzed or the establishment inspection report has not been completed, and seizure has not yet been considered, you may wish to defer action until the entire case can be considered at one time. In such instances, discuss the matter with investigations branch and/or the laboratory to expedite processing of the report or the samples.

Conduct a thorough review of the evidence. For example, review the firm's regulatory history to determine who was responsible for the violations and whether prior warning has been given. Review inspection reports to ensure that any inspectional observations that are inconsistent with analytical results are addressed. Ensure that reserve samples are available, where required. In labeling violations, search the file to determine whether the firm has revised the labeling since the shipment of the samples in question.

A citation may be based solely on establishment inspection evidence. A minimum of two documentary samples covering violative products is desirable.

NOTE: Under normal circumstances, notice and an opportunity to present information and views will always be given before violations are reported for criminal prosecution. However, there are certain circumstances under which notice and opportunity need not be provided. Notice and opportunity need not be given when there is reason to believe that alerting the prospective defendants by a Section 305 Notice may result in the destruction of evidence, or cause the proposed defendants to flee to avoid prosecution. (21 CFR 7.84(a)(2)). In addition, notice and opportunity need not be given when further investigation by the Department of Justice is contemplated. (21 CFR 7.84(a)(3)).

Such situations are infrequent and should be approved on a case-by-case basis. Submit the facts to the center and request concurrence from the center, OE, and OCC when you do not believe providing notice and an opportunity for presentation of views is appropriate.

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5-1-6 - Time Frames

The following time frames apply to citations:

  1. Field: 15 working days after analysis of most recent sample involved in case.
  2. Center: 15 working days after receipt of the recommendation.

There may be good reasons for exceeding these timeframes in a particular case. For example, analytical procedures may be lengthy, or there may be a need to obtain assistance from other districts to establish responsibility. Document the reasons for delays in the case file.

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5-1-7 - Field Office Citation Procedures

  1. Prior Consultation With OCI
    The Office of Criminal Investigations (OCI) is responsible for reviewing all matters in FDA for which a criminal investigation is recommended, and is the focal point for all criminal matters.

    FDA personnel must refer all criminal matters, regardless of their complexity or breadth, to OCI. This includes criminal search warrants, misdemeanor prosecutions, and citations.

    District management must communicate with its local OCI office before pursuing any criminal matter. This communication is absolutely essential to preclude potential interference with other on-going criminal investigations and to prevent confusion among the components of the Office of Chief Counsel and the Department of Justice that are responsible for handling FDA’s criminal cases. During this communication, OCI is to be provided with all of the facts of the potential case and any additional information that is relevant to, or could impact, the case in any way. OCI will decide promptly whether or not it is interested in pursuing the case and will communicate that decision to the district.

    If OCI chooses not to pursue a criminal matter, the district office, after considering the reasons for the declination, is at liberty to proceed with the case in accordance with the procedures in this chapter.
  2. Authorization To Cite
    Citation may issue either on a direct basis or after the submission of a recommendation to the appropriate center and receipt of concurrence to issue the Section 305 Notice.

    It is incumbent upon the office issuing the Section 305 Notice to ensure that the firm and each individual to be cited have received prior warning, unless such warning is not required.
    1. Direct Citation
      CPGs give field offices authority to issue Section 305 Notices in cases where specific criteria are met. Most of these guidelines involve filth violations or noncompliance with standards. Check the manual each time the district office believes citation is the action of choice to preclude submitting unnecessary recommendations to a center.
    2. Citation Recommendation
      Where the district office does not have direct citation authority, it should submit a citation recommendation to the appropriate center for approval.

      The recommendation should include the full background of the case, the history of notification, and the facts supporting the violation(s) for which prosecution is being considered. Include the names and responsibilities of each individual to be cited, the proposed charges, and the supporting samples. Submit any labels, worksheets, and pertinent inspection reports. Identify and discuss any issues, concerns, discrepancies, or other problems with the case. The recommendation package should be well-organized, tabbed, and indexed. The recommendation should identify the location of supporting information it discusses. Interstate (IS) documentation remains the responsibility of the districts and need not be submitted. However, the center may request IS documentation if there’s a special need to review it.
    3. Citation Recommendation After or Concurrently with Seizure
      When the district follows a seizure action with a citation recommendation based on the same underlying violations, it is acceptable to submit a memorandum that references information in the seizure recommendation, provided that the center has all of the labeling and other documents necessary to consider the citation.

      When the district office is recommending citation at the same time it is recommending seizure, flag the recommendation memorandum as "Seizure and Citation Recommendation."

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5-1-8 - Determination Of Citees

  1. Corporations, Partnerships, and Associations
    Corporations, partnerships, and associations are "persons" under the Act, and may be prosecuted as separate legal entities. They should always be included in the citation.

  2. Individuals
    In every case, carefully consider citing individuals. Prior warning is a prerequisite except where the violation involves a danger to health, fraud, or where the violation is extremely gross.

    It is FDA policy to cite officers of corporations and members of partnerships and associations, when the available evidence establishes that the individual stood in a "responsible relationship" to the violation. As the U.S. Supreme Court stated in U.S. v. Park: "The Act imposes not only a positive duty to seek out and remedy violations when they occur but also, and primarily, a duty to implement measures that will insure that violations will not occur."

    Persons who have the power and authority, and therefore the responsibility, to carry out these duties and fail to do so, are logical candidates for citation. Obtain the type of information needed to demonstrate responsibility from observations reported by the investigators, through correspondence and/or memoranda of conferences with the individuals, or through other means. In addition, if there is a need, obtain information from officers and individuals located at a parent plant, as well as persons at the inspected plant.

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5-1-9 - Setting Date For Meeting

If the firm and individuals to be cited are located within a reasonable proximity of the office in which the meeting is to be held, schedule the meeting for approximately 10 days after issuing the Section 305 Notice. If the citees must travel extensive distances or wish to have a corporate attorney in attendance, or the violations involved are complex, schedule the meeting approximately 20 days after issuing the Section 305 Notice.

When there are multiple citees, schedule a separate meeting for any citee who requests one in writing. The meeting may be held at a separate time on the same date or on a separate date. The citee must submit the request to the office that issued the Section 305 Notice, and the request must be received at least three working days before the date set in the notice.

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5-1-10 - Preparation Of Citation Documents

  1. Section 305 Notice (Exhibit 5-1)
    Insert the district address under the printed heading "Food and Drug Administration." Under the caption at the right, "In reply refer to," insert the key or file reference sample number for the action, and "et. al." if there are several samples involved. If there is only one product or class of products, such as "drugs," bakery products," etc., identify the product directly below the reference sample number. The complete list of samples will appear on the Charge Sheet along with the respective products. See Exhibits 5-2 and 5-3 for examples of charge sheets.

    Enter the date that Notice issues directly above the rectangle on "Section 305 Notice" or centered under the city and state of the district's address.

    In the space for addressee, insert the name and address of the firm or sole owner cited (primary citee). When the citation also names responsible individuals, address it in the following manner:

    Standard Pharmaceutical Co.
    and Mr. Henry Jones
    and Mr. John Doe
    125 Main Street
    Canton, Ohio 28531

    (Do not show titles of individuals listed as citees.)

    In the body of the Notice, following the phrase "with respect to the following," enter clear, concise statements identifying the specific interstate shipment and product for each sample on which citation is issuing. In each statement include the name of the product, sufficient quotation from the label to identify the brand, size, etc., the date of shipment, where the shipment originated, and where and to whom it was consigned. When there is more than one sample, show sample numbers in parenthesis following the description of each shipment. If there is insufficient space on the form to enter the samples and shipments involved, enter the notation "See Page 2" conspicuously in the body of the Notice and continue the additional information regarding the samples on a separate page captioned as follows: "Page 2 - Section 305 Notice".

    NOTE: When charging violations involving items other than shipments, include a concise factual statement of the violations (see Exhibits).

    Following the words, "A meeting has been scheduled for," insert the day, date, specific time and location of the meeting. Add any other information that may facilitate the citee's appearance in parentheses following this statement (e.g., availability of parking near the building).

    Type the name of the Compliance Officer who will conduct the meeting at the bottom of the form, and have that individual sign the copies mailed to the firm and each individual cited.

    If individuals have been cited along with the firm, show distribution on all copies of the Notice under the parenthetical statement: "(IMPORTANT: NOTE ALL ENCLOSURES CAREFULLY)" such as: 1 cc to Mr. John Doe and to Mr. Robert Roe each with Charge Sheet and Information Sheet.

  2. Charge Sheet (Form FDA 1854) (Exhibit 5-2)
    Use Form FDA 1854. Under the title, list each sample and product in ascending numerical order. If the list of samples is long, arrange it in two columns.

    Under the heading "PROHIBITED ACT” state the section(s) of the law(s) violated and the statutory description from the law. In charges involving Title 18 or Title 42, cite those laws.

    At the left of the sheet, following the above paragraph type the word "CHARGES". If only one sample and charge are involved, enter the statement "The article is violative in that" followed by the non-legal description of the violation. In the case of multiple charges, enter the statement: "The article is violative in the following respects:" and list each charge separately, numbered as "1," "2," "3," etc.

    When a number of samples and charges are involved, use the statement "The articles are violative in the following respects:" and list the charges as described above. Show the sample numbers involved at the left of each charge.

    State the charges in “lay language.” There is no need to reference specific sections of the Act (other than the "Prohibited Act") or the regulations. Exhibit 5-3 contains examples of charges.

  3. Legal Status Sheet (Form FDA 454) (Exhibit 5-4)
    Enter the sample numbers involved in the citation in the upper right hand side of the form following the caption "Sample No."; and the date(s) of the alleged violations over the "(Date)" caption following line "A." If more than two dates are involved, show the earliest and latest dates only; for example "3/3/94 thru 4/12/94." The district office makes no other entries.

  4. Information Sheet (Form FDA 466a) (Exhibit 5-5)
    This form describes the purpose and nature of the meeting. It is not necessary to type any information on the form; however, it is mandatory that a form accompany the Section 305 Notice sent to each individual cited.

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5-1-11 - Distribution of Citation Documents

  1. Distribute the Section 305 Notice, Charge Sheet, Legal Status Sheet, and Information Sheet as follows:

    1. Send a signed, original copy of the Section 305 Notice, a Charge Sheet, an Information Sheet, and a Legal Status Sheet to the primary citee (generally the firm).

    2. Send a signed copy of the Section 305 Notice, a copy of the Charge Sheet, and an Information Sheet, to each of the other citees, if it is a joint citation.

    3. Forward one copy of the Section 305 Notice, together with one copy of the Charge Sheet, to the factory file, the reading file, and, if applicable, to the district resident post.

    4. Retain three copies of the Section 305 Notice and the Charge Sheet in the District Sample File for use when making a recommendation for disposition of the charges.

  2. Mailing Instructions

    Mail the Section 305 Notice in a regular, letter size envelope with the typed name and address of the citee. Do not use window envelopes. When individuals are cited along with a firm, circle or underline their names on their respective copies and mail each citee's copy in a separate envelope. Where the interests of the individual citees may be at odds, you may send the individual notices to the home addresses of the citees.

    Send the Section 305 Notice by certified mail with return receipt requested.

  3. Postponement Of Meetings

    Districts may grant a reasonable postponement of a meeting upon written request by a citee or person representing a citee (see exception below). The length of the postponement will depend on particular circumstances, but should avoid excessive delay. Confirm the new date by a letter to the citee or representative who requested the postponement. Provide an information file copy to the center.

    Exception: If an office in headquarters directed that the meeting be scheduled within a certain time frame, do not agree to postponements without first consulting with that office.

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5-1-12 - Transfer of Meeting

Occasionally citees will request a transfer of the scheduled meeting to another city in the district area, to another district office, or to Washington headquarters. The citee also has the option of answering by other means when personal appearance at the district headquarters is impractical.

  1. Transfer Within District Area

    Do not grant requests for transfer of the meeting to another city in the district area. The cost to the public of holding the meeting in another city outweighs any benefit or convenience to the citee.

  2. Transfer to Another District

    A request to transfer a meeting to another district may be granted if reasonable grounds are presented, the request is addressed to the office that issued the Section 305 Notice, and the request is received in that office at least 3 working days prior to the date set in the notice. (See 21 CFR 7.84(e)). However, before granting the request to transfer the meeting, check with the district involved to make sure it can handle the meeting.

    Once the request is granted, verify the transfer by letter to the citee.  Send two copies of the letter to the new district with these attachments:

    1. complete file on the samples involved
    2. pertinent Establishment Inspection Reports (EIR's)
    3. a FACTS printout of firm's record, if pertinent to the case

    The home district should establish a temporary jacket as a record of the transfer.

    The transferee district will reschedule the meeting promptly and advise accordingly. This may be done by letter with reference to the original Section 305 Notice and to the letter approving transfer from the original district. Forward copies to the home district.

    After the meeting, send the Record and any exhibits to the home district along with the original files.

    Prepare a skeleton sample jacket containing a copy of the Record, transcripts (if any), and copies of any collateral correspondence that may have issued on the case.

  3. Transfer to Headquarters

    Discourage requests by citees, before or during the meeting, to transfer the meeting to headquarters.

    If, however, the citee insists that the meeting be held at headquarters, refer the request to the center involved. If granted, the center will inform the citee and home district of the new date set for the meeting. The district should then promptly forward the case file to the center for review and use during the meeting. The center will return the case file with the Record to the home district for disposition of the charges.

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5-1-13 - Correspondence with Attorneys

Attorneys representing clients who received a Section 305 Notice will often correspond with the district compliance officer regarding the Section 305 Notice. Because the issuance of a Section 305 Notice is confidential and generally not releasable to the public until all potential criminal matters are resolved, district compliance officers are responsible for ensuring that representatives of the citee provide appropriate documentation regarding their authorization (see 21 CFR 7.84(g)).

It is not necessary to send citees copies of correspondence from their attorneys. However, when a citee is identified as having received a copy of the citee’s attorney’s correspondence, and we have responded to that correspondence, you may wish to send the citee a copy of our response.

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5-1-14 - Drug Advertising Citations

Due to the specialized nature of medical advertising, the Division of Drug Marketing, Advertising and Communications (DDMAC), Center for Drug Evaluation and Research (CDER) is the primary reviewer of drug advertisements. With few exceptions, DDMAC will initiate citations based on violative drug advertisements.

After determining that an advertisement is violative and that citation is warranted, DDMAC may initiate a request for samples to support an action. Samples that are obtained are routed to the home district of the responsible firm.

DDMAC will prepare citation instructions for issuance by the appropriate district. The instructions will specify whether the meeting is to be held at the district office or at headquarters. In most cases, meetings are held at headquarters.

The district will issue the Section 305 Notice in the normal manner, with a copy to DDMAC.

Following the meeting, DDMAC will make a decision on the disposition of the charges and notify the district of that decision.

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