Source: https://www.federalregister.gov/articles/2014/05/29/2014-12458/administrative-detention-of-drugs-intended-for-human-or-animal-use
Timestamp: 2015-08-29 00:16:23
Document Index: 588897936

Matched Legal Cases: ['art 1', 'art 1', '§ 1', 'art 1', 'art 1', 'art 16', '§ 16', 'art 16', '§ 1', '§ 1', '§ 1', '§ 1', 'art 16', '§ 16', '§ 16', '§ 800']

Dates: This rule is effective June 30, 2014.
-30721 (6 pages)
Shorter URL: https://federalregister.gov/a/2014-12458 Related Topics
FDA is issuing this final rule under section 304(g) of the FD Act (21 U.S.C. 334(g)), as amended by section 709 of FDASIA, and section 701 of the FD Act (21 U.S.C. 371). Section 304(g) of the FD Act also authorizes FDA to administratively detain devices and tobacco products.
Summary of the Major Provisions Back to Top
In the Federal Register of July 15, 2013 (78 FR 42381), FDA proposed regulations to implement its new authority to administratively detain drugs that an authorized FDA representative conducting an inspection under section 704 of the FD Act (21 U.S.C. 374) has reason to believe are adulterated or misbranded. As discussed in the preamble to the proposed rule, on July 9, 2012, President Obama signed into law FDASIA (Public Law 112-144). Title VII of FDASIA provides FDA with important new authorities to help it better protect the integrity of the drug supply chain. One of those new authorities is section 709, which amends section 304(g) of the FD Act to provide FDA with administrative detention authority with respect to drugs. Section 304(g) of the FD Act, as amended by FDASIA, provides FDA the same authority to detain drugs that section 304(g) already provides FDA with respect to devices and tobacco products. Once these implementing regulations with respect to drugs take effect, the amendments to section 304(g) of the FD Act will allow FDA to administratively detain drugs that an authorized FDA representative conducting an inspection under section 704 of the FD Act has reason to believe are adulterated or misbranded, until FDA has had time to consider what action it should take concerning the drugs, and to initiate legal action, if appropriate.
II. Overview of the Final Rule Including Changes to the Proposed Rule Back to Top
FDA is amending title 21 of the Code of Federal Regulations, part 1 to create an implementing regulation for the administrative detention of drugs. The amendment to part 1 consists of one section, § 1.980, under a new subpart, which is titled “Subpart Q—Administrative Detention of Drugs Intended for Human or Animal Use.” Section 1.980 sets forth the procedures for the administrative detention of drugs encountered during an inspection that are believed to be adulterated or misbranded. The new regulation is closely modeled on the current regulation for the administrative detention of devices (21 CFR 800.55). There are minor differences from the device regulation, including updates to statutory references to refer to drugs instead of devices and changes to language to conform to current Federal Register requirements. Since FDA issued the proposed rule on administrative detention of drugs, FDA has issued other regulations in part 1, requiring reassignment of the section number within part 1. No other changes have been made to the substance of the proposed regulation. Other than renumbering the section, FDA is finalizing the implementing regulations as proposed.
The amendment to part 16 is a technical change. This change amends a statement in § 16.1 so that the scope of part 16 regulatory hearing procedures also will include administrative detention authority with respect to drugs.
(Response 1) The Agency does not have the authority to change the administrative detention standard, which is specified by statute. Section 304(g) of the FD Act provides, in relevant part: “If during an inspection conducted under section 704 of a facility or vehicle, a drug which the officer or employee making the inspection has reason to believe is adulterated or misbranded is found in such facility or vehicle, such officer may order the drug detained (in accordance with regulations prescribed by the Secretary).” Furthermore, we note that the terms “adulterated” and “misbranded” are well characterized by both the adulteration and misbranding provisions of the FD Act, its implementing regulations, and a substantial body of case law. For example, sections 501 and 502 of the FD Act (21 U.S.C. 351 and 352) provide criteria for determining whether a drug will be considered to be adulterated or misbranded, respectively. Because these terms are already well characterized, we do not believe it necessary or appropriate to further define or modify the meaning of these terms for the purposes of this rule.
(Response 2) The commenter's reference to “shipper and “consignor” indicate that the commenter is confusing administrative detention of a drug during an inspection under section 304(g) of the FD Act with the process of reviewing imported products under section 801(a) of the FD Act (21 U.S.C. 381). Under § 1.94, when it appears to FDA that an imported article may be subject to refusal of admission under section 801(a) of the FD Act, FDA provides a notice of that fact to the owner or consignee and provides them with an opportunity to introduce testimony. This notice is commonly called a “Notice of Detention and Hearing” (see, e.g., FDA Regulatory Procedures Manual, chapter 9, pp. 9-29) (Ref. 1) and is not related to administrative detention under section 304(g) of the FD&C Act.
(Response 5) We believe that the detailed notice and appeals procedures set forth in the proposed rule, which includes the opportunity for an informal hearing within 5 working days after the appeal is filed, satisfy the elements of due process. We appreciate the commenter's concern that an administrative detention could lead to a drug shortage and note that the Agency has an active drug shortages program. Preventing drug shortages has been, and continues to be, a top priority for FDA, and we take great efforts to address, prevent, and mitigate drug shortages. Yet in making regulatory and enforcement decisions, FDA not only is concerned with the potential for drug shortages, but also with the potential for harm to patients caused by an adulterated or misbranded drug entering into commerce.
(Response 6) FDA believes that § 1.980(h)(3)(i) provides the flexibility sufficient to preserve product quality and integrity during an administrative detention. Paragraph (h)(3) states that an authorized FDA representative “may approve, in writing, the movement of detained drugs for any of the following purposes: (i) To prevent interference with an establishment's operation or harm to the drugs.”
V. Analysis of Impacts (Summary of the Regulatory Impact Analysis) Back to Top
The full discussion of economic impacts is available in docket FDA-2013-N-0365 and at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm (Ref. 3).
2. “Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2011/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products,”Official Journal of the European Union, January 7, 2011, available at http://ec.europa.eu/health/files/eudralex/vol-1/dir_2011_62/dir_2011_62_en.pdf.
3. Final Regulatory Impact Analysis, Final Regulatory Flexibility Analysis, and Unfunded Mandates Reform Act Analysis for Administrative Detention of Drugs Intended for Human or Animal Use, available at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.
Subparts L-P—[Added and Reserved] Back to Top
2.Add and reserve subparts L through P. 3.Add subpart Q, consisting of § 1.980, to read as follows: Subpart Q—Administrative Detention of Drugs Intended for Human or Animal Use Back to Top
§ 1.980 Administrative detention of drugs.
4.The authority citation for 21 CFR part 16 is revised to read as follows: Authority:
5.Revise the first sentence of § 16.1 paragraph (b)(1) to read as follows: § 16.1 Scope.
(1) Statutory provisions: Section 304(g) of the act relating to the administrative detention of devices and drugs (see §§ 800.55(g) and 1.980(g) of this chapter).