text: SECTION 1. SHORT TITLE.
  
      This Act may be cited as the ``Recall Unsafe Drugs Act of 2017''.
  
  SEC. 2. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF ADULTERATED OR 
                MISBRANDED DRUGS.
  
      (a) Prohibited Acts.--Section 301 of the Federal Food, Drug, and 
  Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the 
  following:
      ``(eee) The failure to comply with--
              ``(1) the notification requirement under section 569D(a);
              ``(2) an order issued under paragraph (1) of section 
          569D(c), following a hearing, if requested, under paragraph 
          (2)(C) of such section;
              ``(3) an order amended under paragraph (2) or paragraph (3) 
          of section 569D(c); or
              ``(4) an emergency order issued under section 569D(d).
      ``(fff) The failure to have in effect a recall plan under section 
  569(g).''.
      (b) Nondistribution and Recall of Adulterated or Misbranded 
  Drugs.--Subchapter E of chapter V of the Federal Food, Drug, and 
  Cosmetic Act (21 U.S.C. 360bbb et seq.) is amended by adding at the end 
  the following:
  
  ``SEC. 569D. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF CERTAIN 
                ADULTERATED OR MISBRANDED DRUGS.
  
      ``(a) Notification Regarding Certain Adulterated or Misbranded 
  Drugs.--
              ``(1) In general.--Any person required to register under 
          section 510 shall, as soon as practicable, notify the Secretary 
          of the identity and location of a drug, if such person has 
          reason to believe--
                      ``(A) that such drug, when introduced into or while 
                  in interstate commerce, or while held for sale 
                  (regardless of whether the first sale) after shipment 
                  in interstate commerce, is adulterated or misbranded; 
                  and
                      ``(B) there is a reasonable probability that the 
                  use or consumption of, or exposure to, the drug (or an 
                  ingredient or component used in any such drug) will 
                  cause a threat of serious adverse health consequences 
                  or death to humans or animals.
              ``(2) Manner of notification.--Notification under paragraph 
          (1) shall be made in such manner and by such means as the 
          Secretary may require by regulation or guidance.
      ``(b) Voluntary Recall.--The Secretary may request that any person 
  who distributes a drug that the Secretary has reason to believe is 
  adulterated, misbranded, or otherwise in violation of this Act 
  voluntarily--
              ``(1) recall such drug; and
              ``(2) provide for notice, including to individuals as 
          appropriate, to persons who may be affected by the recall.
      ``(c) Order To Cease Distribution and Recall Drug and Related 
  Procedures.--
              ``(1) Issuance of order.--If the Secretary has reason to 
          believe that the use or consumption of, or exposure to, a drug 
          (or an ingredient or component used in any such drug) may cause 
          serious adverse health consequences or death to humans or 
          animals, the Secretary shall have the authority to issue an 
          order requiring any person who distributes such drug--
                      ``(A) to immediately cease distribution of such 
                  drug; and
                      ``(B) to provide for notice, including to 
                  individuals as appropriate, to persons who may be 
                  affected by such cessation of distribution.
              ``(2) Action following order.--
                      ``(A) Cease distribution and notification.--Any 
                  person who is subject to an order under paragraph (1) 
                  shall immediately cease distribution of such drug and 
                  provide notification as required by such order.
                      ``(B) Appeal.--Any person who is subject to an 
                  order under paragraph (1) may appeal within 24 hours of 
                  issuance such order to the Secretary. Such appeal may 
                  include a request for an informal hearing and a 
                  description of any efforts to recall such drug 
                  undertaken voluntarily by the person, including after a 
                  request under subsection (b).
                      ``(C) Informal hearing.--Except as provided in 
                  subsection (d), if an appeal made under subparagraph 
                  (B) contains a request for an informal hearing, such 
                  hearing shall be held as soon as practicable, but not 
                  later than 5 calendar days, or less as determined by 
                  the Secretary, after such an appeal is filed, unless 
                  the parties jointly agree to an extension.
                      ``(D) Determination.--After affording an 
                  opportunity for an informal hearing, the Secretary 
                  shall determine--
                              ``(i) whether--
                                      ``(I) the order under paragraph (1) 
                                  should be amended to require a recall 
                                  of such drug; or
                                      ``(II) inadequate grounds exist to 
                                  support the actions required by the 
                                  order; or
                              ``(ii) that the order under paragraph (1) 
                          was appropriate as issued.
                      ``(E) Amendment or vacation of order.--
                              ``(i) Amendment.--In the case of a 
                          determination made under subparagraph 
                          (D)(i)(I), the Secretary shall amend the order 
                          made under paragraph (1) accordingly.
                              ``(ii) Vacation.--In the case of a 
                          determination made under subparagraph 
                          (D)(i)(II), the Secretary shall vacate the 
                          order made under paragraph (1).
              ``(3) Order to recall.--
                      ``(A) Amendment.--Except as provided under 
                  subsection (d), if after providing an opportunity for 
                  an informal hearing under paragraph (2)(C), the 
                  Secretary determines that the order should be amended 
                  to include a recall of the drug with respect to which 
                  the order was issued, the Secretary shall amend the 
                  order to require a recall.
                      ``(B) Contents.--An amended order under 
                  subparagraph (A) shall--
                              ``(i) specify a timetable in which the 
                          recall will occur;
                              ``(ii) require periodic reports to the 
                          Secretary describing the progress of the 
                          recall; and
                              ``(iii) provide for notice, including to 
                          individuals as appropriate, to persons who may 
                          be affected by the recall.
                  In providing for such notice, the Secretary may allow 
                  for the assistance of health professionals, State or 
                  local officials, or other individuals designated by the 
                  Secretary.
                      ``(C) Nondelegation.--An amended order under this 
                  paragraph shall be ordered by the Secretary or an 
                  official designated by the Secretary. An official may 
                  not be so designated unless the official is the 
                  director of the district under this Act in which the 
                  drug involved is located, or is an official senior to 
                  such director.
      ``(d) Emergency Recall Order.--
              ``(1) In general.--If the Secretary has credible evidence 
          or information that a drug subject to an order under subsection 
          (c)(1) presents an imminent threat of serious adverse health 
          consequences or death to humans or animals, the Secretary may 
          issue an order requiring any person who distributes such drug--
                      ``(A) to immediately recall such drug; and
                      ``(B) to provide for notice, including to 
                  individuals as appropriate, to persons who may be 
                  affected by the recall.
              ``(2) Action following order.--
                      ``(A) Recall and notification.--Any person who is 
                  subject to an emergency recall order under this 
                  subsection shall immediately recall such drug and 
                  provide notification as required by such order.
                      ``(B) Appeal.--
                              ``(i) Timing.--Any person who is subject to 
                          an emergency recall order under this subsection 
                          may appeal within 24 hours after issuance such 
                          order to the Secretary.
                              ``(ii) Continuation of recall.--The person 
                          subject to an emergency recall order shall 
                          conduct the recall notwithstanding the pendency 
                          of any appeal of such order.
                      ``(C) Informal hearing.--An informal hearing shall 
                  be held as soon as practicable but not later than 5 
                  calendar days, or less as determined by the Secretary, 
                  after an appeal under subparagraph (B) is filed, unless 
                  the parties jointly agree to an extension.
                      ``(D) Determination.--After affording an 
                  opportunity for an informal hearing, the Secretary 
                  shall determine--
                              ``(i) whether--
                                      ``(I) the order under paragraph (1) 
                                  should be amended to require a recall 
                                  of such drug; or
                                      ``(II) inadequate grounds exist to 
                                  support the actions required by the 
                                  order; or
                              ``(ii) that the order under paragraph (1) 
                          was appropriate as issued.
                      ``(E) Amendment or vacation of order.--
                              ``(i) Amendment.--In the case of a 
                          determination made under subparagraph 
                          (D)(i)(I), the Secretary shall amend the order 
                          made under paragraph (1) accordingly.
                              ``(ii) Vacation.--In the case of a 
                          determination made under subparagraph 
                          (D)(i)(II), the Secretary shall vacate the 
                          order made under paragraph (1).
              ``(3) Nondelegation.--An order under this subsection shall 
          be issued by the Commissioner of Food and Drugs, the Principal 
          Deputy Commissioner, or the Associate Commissioner for 
          Regulatory Affairs of the Food and Drug Administration.
      ``(e) Notice to Consumers and Health Officials.--The Secretary 
  shall, as the Secretary determines to be necessary, provide notice of a 
  recall order under this section to consumers to whom the drug was, or 
  may have been, distributed and to appropriate State and local health 
  officials.
      ``(f) Savings Clause.--Nothing contained in this section shall be 
  construed as limiting--
              ``(1) the authority of the Secretary to issue an order to 
          cease distribution of, or to recall, a drug under any other 
          provision of this Act or the Public Health Service Act; or
              ``(2) the ability of the Secretary to request any person to 
          perform a voluntary activity related to any drug subject to 
          this Act or the Public Health Service Act.
      ``(g) Recall Plan.--Any person required to register under section 
  510 shall have in effect a recall plan consistent with the requirements 
  of this section.''.
      (c) Delayed Applicability.--The amendments made by this section 
  apply beginning on the date that is one year after the date of the 
  enactment of this Act.
target: Recall Unsafe Drugs Act of 2017 This bill amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to require producers of medications to notify the Food and Drug Administration (FDA) of the identity and location of a medication if the producer has reason to believe: (1) that the medication is adulterated or misbranded; and (2) there is a reasonable probability that the use or consumption of, or exposure to, the medication will cause a threat of serious adverse health consequences or death to humans or animals. The FDA may: (1) request that the distributor of a medication that is in violation of the FFDCA voluntarily recall the medication; (2) require the distributor of a medication that may cause serious adverse health consequences to immediately cease distribution of the medication; (3) recall a medication for which distribution has been ceased after giving the distributor an opportunity for an informal hearing; and (4) immediately recall a medication that presents an imminent threat of serious adverse health consequences. Distributors may appeal these FDA orders. In the case of a recall, the FDA must notify consumers and state and local health officials to whom the medication was, or may have been, distributed. Medication distributors must have a recall plan in effect.
feat_title: Recall Unsafe Drugs Act of 2017