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Compliance References
Regulatory Procedures Manual 2008
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5-8 - CIVIL MONEY PENALTIES
     5-8-1 - Civil Money Penalty Authorities
     5-8-2 - Reduction Of Civil Money Penalties For Small Entities
     5-8-3 - Civil Money Penalty Recommendations

5-8 - CIVIL MONEY PENALTIES

5-8-1 - Civil Money Penalty Authorities

The Civil Money Penalties included in this section are monetary penalties that are assessed by FDA for violations of the Federal Food, Drug, and Cosmetic Act or the Public Health Service Act. Information on electronic products civil penalties under section 539(b) of the Act can be found in Chapter 6, section 6-6.

Civil money penalties (CMPs) are authorized under the following sections of the Federal Food, Drug, and Cosmetic Act (the Act) and the Public Health Service Act. See 21 CFR 17.2 for the current maximum civil money penalty (CMP) amounts allowed.

  1. Food
    1. a. Section 303(f)(2)(A) of the Act, 21 U.S.C. 333(f)(2)(A) – Authorizes CMPs against any person who introduces, or delivers for introduction, into interstate commerce an article of food that bears or contains a pesticide chemical residue that is unsafe within the meaning of section 408(a).

      Section 303(f)(2)(B) states that a CMP cannot be assessed against any person who grew the article of food. That section also prohibits use of the seizure, injunction, or criminal authorities if a CMP is assessed.
  2. Drugs
    1. Section 303(b)(2) of the Act, 21 U.S.C. 333(b)(2) – Authorizes CMPs against a manufacturer or distributor:
      1. if one of their representatives, during the course of their employment or association with the manufacturer or distributor, is convicted of selling, purchasing, or trading or offering to sell, purchase, or trade a prescription drug sample in violation of section 503(c)(1) and 301(t); or is convicted of violating any State law that prohibits the sale, purchase, or trade of a prescription drug sample subject to section 503(b), or the offer to sell, purchase, or trade such a prescription drug sample.
    2. Section 303(b)(3) of the Act, 21 U.S.C. 333(b)(3) – Authorizes CMPs against a manufacturer or distributor:
      1. if they fail to report to the Secretary any convictions of their representatives for violations of section 503(c)(1) or a State law because of the sale, purchase, or trade of a prescription drug sample, or the offer to sell, purchase, or trade a prescription drug sample.
    3. Section 307(a) of the Act, 21 U.S.C. 335b(a) – Authorizes CMPs against any person that:
      1. knowingly made or caused to be made, to any officer, employee, or agent of the Department of Health and Human Services (“DHHS personnel”), a false statement or misrepresentation of a material fact in connection with an abbreviated drug application (ANDA);
      2. bribed or attempted to bribe or paid or attempted to pay an illegal gratuity to “DHHS personnel” in connection with an ANDA;
      3. destroyed, altered, removed, or secreted, or procured the destruction, alteration, removal, or secretion of any material document or other material evidence which was the property of or in the possession of DHHS for the purpose of interfering with DHHS’s discharge of its responsibilities in connection with an ANDA;
      4. knowingly failed to disclose to an officer or employee of DHHS, a material fact relating to any drug subject to an ANDA, which such person had an obligation to disclose;
      5. knowingly obstructed a DHHS investigation into any drug subject to an ANDA;
      6. has an approved or pending drug product application and has knowingly used in any capacity the services of a person who was debarred under section 306; or
      7. is debarred and, during the period of debarment, provided services in any capacity to a person that had an approved or pending drug product application.
  3. Biologics
    1. 42 U.S.C. 262(d)(2) – Authorizes CMPs for any violation of an order issued by the Secretary to immediately recall a batch, lot, or other quantity of a licensed biological product that presents an imminent or substantial hazard to the public health.
    2. 42 U.S.C. 300aa-28(b)(1) – Authorizes CMPs against any vaccine manufacturer who intentionally destroys, alters, falsifies, or conceals any record or report required by 42 U.S.C. 300aa-28(a)(1) or (2).

      The penalty applies to the person who intentionally destroyed, altered, falsified, or concealed such record or report; to the person who directed that such record or report be destroyed, altered, falsified, or concealed; and to the vaccine manufacturer for which such person is an agent, employee, or representative. Each act of destruction, alteration, falsification, or concealment is treated as a separate occurrence.
  4. Devices
    1. Section 303(g)(1)(A) of the Act, 21 U.S.C. 333(g)(1)(A) – Authorizes CMPs against any person who violates a requirement which relates to devices. Except that, in accordance with Section 303(g)(1)(B), CMPs do not apply to:
      1. any person who violates the requirements of section 519(a) (e.g., Medical Device Reporting), or section 520(f) (Quality System Regulation), unless the violations constitute a significant or knowing departure from the requirements, or a risk to public health;
      2. any person who commits minor violations of section 519(e) (Device Tracking), or section 519(f) (only with respect to correction reports), if the person demonstrates substantial compliance with such section; or
      3. violations of section 501(a)(2)(A) which involve one or more devices which are not defective. Note that a person accredited under section 704(g) who is substantially not in compliance with the standards of accreditation under that section, or who poses a threat to public health or fails to act in a manner that is consistent with the purposes of that section, is considered to have violated a requirement that relates to devices.
  5. Mammography Facilities
    1. 42 U.S.C. 263b(h)(3) – Authorizes CMPs for:
      1. Failure to obtain a certificate as required by 263b(b);
      2. Each failure by a facility to substantially comply with, or each day on which a facility fails to substantially comply with, the quality standards set forth in 21 CFR Part 900, or with the requirements of 263b(d)(1(B)(ii);
      3. Each failure to notify a patient of risk as required pursuant to 263b(h)(2); and
      4. Each violation, or for each aiding and abetting in a violation of, any provision of or regulation promulgated under, this section by an owner, operator, or any employee of a facility required to have a certificate.

 

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5-8-2 - Reduction Of Civil Money Penalties For Small Entities

The Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA) (Public Law 10-121) was enacted on March 29, 1996, and seeks to improve the regulatory climate for small entities by, among other things, requiring agencies to establish small entity penalty reduction policies.

The Food and Drug Administration (FDA) has issued final guidance for the reduction of CMPs for small entities (penalty reduction guidance) as mandated by the SBREFA and the Presidential Memorandum of April 21, 1995 (60 FR 20621, April 26, 1995). This guidance can be obtained on FDA’s internet site at http://www.fda.gov/OHRMS/DOCKETS/98fr/010049gd.pdf

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5-8-3 - Civil Money Penalty Recommendations

When it is determined that Civil Money Penalty is the appropriate course of action, the District’s Compliance Officer should submit the recommendation package to the appropriate Center.

  1. DISTRICT RESPONSIBILITIES
    The District recommends a Civil Money Penalty by transmitting to the Center, at a minimum, a cover memorandum recommending the action, a draft cover letter to respondents and a Complaint accompanied by the supporting evidence.

  2. CENTER RESPONSIBILITIES
    The Center is responsible for the technical, regulatory, policy and scientific review of the District’s Civil Money Penalty recommendation. Changes to proposed recommendations should be made only after discussion with the District’s compliance staff.

    Approved referrals transmitted to DCMO should include intact original case files organized as submitted from the District, the Center’s proposed changes to respondent letters/Complaint and the Center’s approval memorandum providing Center contact information, justification for imposition of civil money penalties and other information necessary to review and process the action.

  3. DCMO RESPONSIBILITIES
    OE, Division of Compliance Management and Operations will review the appropriateness of the action and the adequacy of the draft cover letter to respondents and Complaint to ensure compliance with existing procedures, policies, regulations or statutes. Changes to proposed recommendations should be made only after discussion with the Center and the District’s compliance staff.

    Approved recommendations to OCC should include DCMO’s transmittal memorandum, DCMO’s proposed changes to the respondent letters/Complaint and original materials submitted by the District and Center.

  4. OFFICE OF CHIEF COUNSEL RESPONSIBILITIES
    OCC Approved recommendations will be processed in accordance with procedures outlined in 21 CFR Part 17; or, in the case of civil penalties authorized under section 307(a) of the Act, in accordance with the procedures in section 307(b) of the Act.

 

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