Source: https://www.federalregister.gov/documents/2014/05/29/2014-12458/administrative-detention-of-drugs-intended-for-human-or-animal-use
Timestamp: 2016-09-28 02:07:36
Document Index: 792732675

Matched Legal Cases: ['art 1', 'art 16', 'arts 1', 'arts 1', 'art 16', 'art 1', 'art 1', '§\u20091', 'art 1', 'art 1', 'art 16', '§\u200916', 'art 16', '§\u20091', '§\u20091', 'arts 1', 'art2', 'art3', '§\u20091', '§\u20091', '§\u200916', '§\u200916', '§\u200916', '§\u200916', 'art 5', '§\u200916', 'art 211', 'art5', '§\u200916', '§\u200916', '§\u2009800']

:: Administrative Detention of Drugs Intended for Human or Animal Use
30716-30721
A. Revisions to Part 1
B. Revisions to Part 16
A. Standard for Administrative Detention Order
B. Notification of Detention Order
C. Appeals of Detention Orders
D. Movement of Detained Drugs
E. Notification of Detention Termination
F. Enforcement Concerns
G. Foreign Inspections
H. Harmonization With European Union Legislation
V. Analysis of Impacts (Summary of the Regulatory Impact Analysis)
Subparts L-P—[Added and Reserved]
Subpart Q—Administrative Detention of Drugs Intended for Human or Animal Use
https://www.federalregister.gov/d/2014-12458
Charlotte Hinkle, Office of Regulatory Affairs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 4343, Silver Spring, MD 20993-0002, 301-796-5300, FDASIAImplementationORA@fda.hhs.gov.
FDA's administrative detention authority with respect to drugs intended for human or animal use allows FDA to better protect the integrity of the drug supply chain. Specifically, administrative detention is intended to protect the public by preventing distribution or subsequent use of drugs encountered during inspections that may be 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. FDA already has the authority to administratively detain devices, tobacco, and foods that FDA has reason to believe are adulterated or misbranded.
FDA is issuing this final rule under section 304(g) of the FD&C Act (21 U.S.C. 334(g)), as amended by section 709 of FDASIA, and section 701 of the FD&C Act (21 U.S.C. 371). Section 304(g) of the FD&C Act also authorizes FDA to administratively detain devices and tobacco products.
This final rule implements a regulation for the administrative detention of drugs. FDA is amending parts 1 and 16 (21 CFR parts 1 and 16) to create an implementing rule for this authority. The changes set forth the procedures for detention of drugs believed to be adulterated or misbranded and amend the scope of FDA's part 16 regulatory hearing procedures to include the administrative detention of drugs.
The primary public health benefits from adoption of the final rule would be the value of the illnesses or deaths prevented because the Agency administratively detained a drug it has reason to believe is adulterated or misbranded; this benefit occurs only if the drug would not have been prevented from entering the market using one of the Agency's other enforcement tools. The estimated primary costs to FDA include marking or labeling the detained product and costs associated with appeals of detention orders. The Agency estimates the net annual social costs to be between $0 and $602,602.
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&C 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&C Act to provide FDA with administrative detention authority with respect to drugs. Section 304(g) of the FD&C 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&C Act will allow FDA to administratively detain drugs that an authorized FDA representative conducting an inspection under section 704 of the FD&C 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.
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 Start Printed Page 30717detention authority with respect to drugs.
FDA received six comments in the docket for the July 15, 2013, proposed rule on administrative detention of drugs, three of which were responsive. However, after considering these comments, the Agency is not making any changes to the regulatory language included in the proposed rule. Relevant portions of the responsive comments are summarized and responded to in this document. The Agency did not consider nonresponsive comments in developing this final rule. To make it easier to identify comments and our responses, the word “Comment,” in parentheses, appears before the comment's description, and the word “Response,” in parentheses, appears before our response. We have numbered each comment and response to help distinguish between different comments. Similar comments are grouped together under the same number. The number assigned to each comment is purely for organization purposes and does not signify the comment's value or importance or the order in which it was received. Comments addressing the proposed implementing regulation for the administrative detention of drugs and FDA's responses follow.
In the proposed rule, FDA proposed that an administrative detention of drugs may be ordered when an authorized FDA representative, during an inspection under section 704 of the FD&C Act, has reason to believe that a drug is adulterated or misbranded. Two comments suggested the Agency modify the proposed standard for issuing an administrative detention order.
(Comment 1) One commenter stated that the term “adulteration” is very broad and suggested that, to ensure that patients continue to have access to safe medications, the Agency should add an element of potential risk of public harm to the detention standard.
(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&C 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&C Act, its implementing regulations, and a substantial body of case law. For example, sections 501 and 502 of the FD&C 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.
(Comment 2) One commenter suggested that the Agency should administratively detain shipments based on a pre-determined, justified level of suspicion, with an example that the Agency may wish to scrutinize more closely shipments that are not from a known shipper or known consignor.
(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&C Act with the process of reviewing imported products under section 801(a) of the FD&C 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&C 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.
In the proposed rule, FDA proposed that the detention order be issued in writing, in the form of a detention notice, signed by the authorized FDA representative who has reason to believe that the drugs are adulterated or misbranded, and issued to the owner, operator, or agent in charge of the place where the drugs are located. If the owner or the user of the drugs is different from the owner, operator, or agent in charge of the place where the drugs are detained, a copy of the detention order must be provided to the owner or user of the drugs if the owner's or user's identity can be readily determined. If detention of drugs in a vehicle or other carrier is ordered, a copy of the detention order must be provided to the shipper of record and the owner of the vehicle or other carrier, if their identities can be readily determined. An FDA representative issuing a detention order must label or mark the drugs with official FDA tags that include certain information.
(Comment 3) One commenter requested that FDA immediately notify the party responsible (e.g., manufacturer or wholesaler) for the detained drug to enable drug owners to inform customers that their orders may be delayed as well as opened and checked by FDA.
(Response 3) We believe that the notice requirements set forth in the proposed rule, which we are adopting, together with the requirement that FDA label or mark the drugs subject to the detention order, address the commenter's concerns regarding FDA notification of detention orders to the owner, operator, or agent in charge of the place where the drugs are located. Furthermore, if the owner or the user of the drugs is different from the owner, operator, or agent in charge of the place where the drugs are located, FDA also will provide a copy of the detention order to the owner or user of the drugs, if their identity can be readily determined. FDA expects such notification to be as timely as possible. The procedures FDA puts into place to implement this rule will address the notice requirements and help ensure that our investigators are appropriately educated and trained on the procedural requirements.
In the proposed rule, FDA proposed that the person who would be entitled to claim the drugs, if seized, may appeal a detention order.
(Comment 4) Two commenters suggested the Agency clarify that it is not the intent of the Agency to limit the manufacturer's ability to appeal a detention order.
(Response 4) Who may appeal a detention order is determined by Federal statute. Section 304(g) of the FD&C Act specifies who may appeal a detention order: “Any person who would be entitled to claim a device, drug, or tobacco product if it were seized under [304(a)] may appeal . . . a detention of such device, drug, or tobacco product. . .”.
(Comment 5) One commenter expressed concern that a drug product subject to a detention order would be withheld from patients without due process, potentially creating a drug shortage.
(Response 5) We believe that the detailed notice and appeals procedures set forth in the proposed rule, which Start Printed Page 30718includes 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.
In the proposed rule, FDA proposed that, except as provided, no person may move a detained drug within or from the place where they were ordered detained until FDA terminates the detention or the detention period expires, whichever occurs first.
(Comment 6) Two commenters noted that administrative detention regulations should provide sufficient flexibility for movement in order to preserve product integrity during the detention process.
(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.”
In the proposed rule, FDA proposed that, if FDA decides to terminate a detention or when the determination period expires, whichever occurs first, an FDA representative authorized to terminate a detention will issue a detention termination notice releasing the drugs to any person who received the original detention order or that person's representative and will remove, or authorize in writing the removal of, the required labels or tags.
(Comment 7) One commenter suggested adding language that FDA will notify, by telephone or other means of rapid communication, the person who received the original detention order or that person's representative of the detention notification.
(Response 7) We understand the concern raised by the commenter but do not believe that the notification of detention requirements should be revised to require notification by telephone or other means of rapid communication. As a general matter, current Agency practice with regard to administrative detentions is to concurrently notify the person who received the original detention order, or that person's representative, of the detention termination when a detention termination notice is sent by mail. We will consider incorporating such notification processes into Agency procedures to implement administrative detentions for drugs.
(Comment 8) One commenter expressed concern regarding the potential for variability of enforcement among FDA's investigators, particularly regarding potential adulteration charges under section 501(j) of the FD&C Act.
(Response 8) The authorities granted to FDA in Title VII of FDASIA, including the authority to enforce the prohibition against delaying, denying, limiting, or refusing an inspection under section 707 of FDASIA, are a comprehensive package, intended to enhance FDA's oversight of the global drug supply chain. Implementation of these new authorities will include measures to help ensure that our investigators are appropriately educated and trained on the new legal authorities and implementing procedures.
(Comment 9) One commenter suggested that FDA highlight the intent and manner in which the Agency intends to collaborate with foreign governments to apply administrative detention authority abroad.
(Response 9) We appreciate this comment; however, the focus of this rule is not on our enforcement implementation, but on the process by which administrative detention of drugs occurs. If, in the future, we determine that administrative detention authority with respect to drugs has a unique application, we will evaluate what guidance or other information we will need to issue to help ensure transparency.
(Comment 10) One commenter suggested that to support global harmonization, FDA harmonize the administrative detention of drugs to the highest possible degree with the European Union Falsified Medicines Directive (EU Directive 2011/62).
(Response 10) FDA appreciates the comment. We do harmonize with legislation of our foreign regulatory counterparts to the extent possible and practicable. In 2011, the European Union (EU) Council issued the Falsified Medicines Directive in an effort to strengthen the EU's ability to detect falsified medicines and prevent their entry into the legitimate supply chain by adding new requirements in four main areas: Safety features, supply chain and good distribution practices, active pharmaceutical ingredients, and Internet sales (Ref. 2). This EU legislation, however, does not address administrative detention of drugs.
FDA is issuing this final rule under sections 304(g) and 701 of the FD&C Act and section 709 of FDASIA. Section 709 of FDASIA provides FDA authority to issue regulations regarding administrative detention authority with respect to drugs. Section 304(g) of the FD&C Act includes FDA's administrative detention authority with respect to drugs. The final rule is necessary for efficient enforcement of the FD&C Act.
FDA has examined the impacts of the final rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive Orders 12866 and 13563 direct Agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The Agency believes that this final rule would not be an economically significant regulatory action as defined by Executive Order 12866.
If a rule has a significant economic impact on a substantial number of small businesses, the Regulatory Flexibility Act requires Agencies to analyze regulatory alternatives that would minimize any significant impact of a rule on small entities. FDA has determined that this final rule would not have a significant economic impact on a substantial number of small entities.
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that Agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may Start Printed Page 30719result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $141 million, using the most current (2013) Implicit Price Deflator for the Gross Domestic Product. FDA does not expect this final rule to result in any 1-year expenditure that would meet or exceed this amount.
The primary public health benefits from adoption of the final rule would be the value of the illnesses or deaths prevented because the Agency administratively detained a drug it has reason to believe is adulterated or misbranded; this benefit occurs only if the drug would not have been prevented from entering the market using one of the Agency's other enforcement tools. There may also be benefits from deterrence if administrative detention increases the likelihood that misbranded or adulterated products will not be marketed in the future.
The estimated primary costs to FDA include marking or labeling the detained product and costs associated with appeals of detention orders. However, other costs, such as loss in market value of a detained drug, may be incurred if FDA revokes the detention order on appeal. Given the history of administrative detention use with medical devices and foods, the likelihood is low of FDA issuing a detention order that is later revoked on appeal.
We estimate the annual costs using a range of 0 to 20 administrative detentions performed each year. The Agency estimates the net annual social costs to be between $0 and $602,602. The present discounted value over 20 years would be in the range of $0 to $8,965,196 at a 3 percent discount rate and in the range of $0 to $6,383,974 at a 7 percent discount rate.
FDA has examined the economic implications of the final rule as required by the Regulatory Flexibility Act. If a rule will have a significant economic impact on a substantial number of small entities, the Regulatory Flexibility Act requires Agencies to analyze regulatory options that would lessen the economic effect of the rule on small entities. We find that this final rule would not have a significant economic impact on a substantial number of small entities. This analysis, together with other relevant sections of this document, serves as the Final Regulatory Flexibility Analysis, as required under the Regulatory Flexibility Act.
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).
This final rule contains no collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3518(c)(1)(B)(ii)). Therefore, clearance by the Office of Management and Budget is not required under the Paperwork Reduction Act of 1995.
The following references have been placed on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday, and are available electronically at http://www.regulations.gov. (FDA has verified the Web site address, but FDA is not responsible for any subsequent changes to the Web site after this document publishes in the Federal Register.)
1. FDA Regulatory Procedures Manual, chapter 9, pp. 9-29.
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.
Therefore, under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, and under authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 1 and 16 are amended as follows:
Start Amendment Part2. Add and reserve subparts L through P.End Amendment Part
Start Amendment Part3. Add subpart Q, consisting of § 1.980, to read as follows:End Amendment Part
§ 1.980 Administrative detention of drugs.
(a) General. This section sets forth the procedures for detention of drugs believed to be adulterated or misbranded. Administrative detention is intended to protect the public by preventing distribution or use of drugs encountered during inspections that may be adulterated or misbranded, until the Food and Drug Administration (FDA) has had time to consider what action it should take concerning the drugs, and to initiate legal action, if appropriate. Drugs that FDA orders detained may not be used, moved, altered, or tampered with in any manner by any person during the detention period, except as authorized under paragraph (h) of this section, until FDA Start Printed Page 30720terminates the detention order under paragraph (j) of this section, or the detention period expires, whichever occurs first.
(i) The detention order under paragraph (d) of this section, rather than the notice under § 16.22(a) of this chapter, provides notice of opportunity for a hearing under this section and is part of the administrative record of the regulatory hearing under § 16.80(a) of this chapter;
(iii) The last sentence of § 16.24(e) of this chapter, stating that a hearing may not be required to be held at a time less than 2 working days after receipt of the request for a hearing, does not apply to a hearing under this section;
(iv) Paragraph (g)(4) of this section, rather than § 16.42(a) of this chapter, describes the FDA employees, i.e., regional food and drug directors, who preside at hearings under this section.
(4) The presiding officer of a regulatory hearing on an appeal of a detention order, who also must decide the appeal, must be a regional food and drug director (i.e., a director of an FDA regional office listed in part 5, subpart M of this chapter) who is permitted by § 16.42(a) of this chapter to preside over the hearing.
(6) If the appellant requests a regulatory hearing and requests that the hearing be held at a date later than Start Printed Page 30721within 5 working days after the appeal is filed, but not later than 20 calendar days after receipt of a detention order, the presiding officer must hold the hearing at a date agreed upon by FDA and the appellant. The presiding officer must decide whether to affirm or revoke the detention within 5 working days after the conclusion of the hearing. The detention period extends to the date of the decision even if the 5-working-day period for making the decision extends beyond the otherwise applicable 20-calendar-day or 30-calendar-day detention period.
(2) Records required under this paragraph must be maintained for a maximum period of 2 years after the issuance of the detention order or for such other shorter period as FDA directs. When FDA terminates the detention or when the detention period expires, whichever occurs first, FDA will advise all persons required under this paragraph to keep records concerning that detention whether further recordkeeping is required for the remainder of the 2-year, or shorter, period. FDA ordinarily will not require further recordkeeping if the Agency determines that the drugs are not adulterated or misbranded or that recordkeeping is not necessary to protect the public health, unless the records are required under other regulations in this chapter (e.g., the good manufacturing practice regulation in part 211 of this chapter). Start Part
Start Amendment Part5. Revise the first sentence of § 16.1 paragraph (b)(1) to read as follows:End Amendment Part
§ 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).
[FR Doc. 2014-12458 Filed 5-28-14; 8:45 am]