SEC. 506G. RECALL AUTHORITY. ``(a) Order To Cease Distribution of Drug; Notification of Health Professionals.-- ``(1) In general.--If the Secretary finds that a drug intended for human use may constitute a threat to the public health, the Secretary shall issue an order requiring the appropriate person (including the manufacturers, importers, distributors, or retailers of the drug)-- ``(A) to immediately cease distribution of the drug; and ``(B) to immediately notify health professionals of the order and to instruct such professionals to cease administering, distributing, selling, or prescribing the drug. ``(2) Informal hearing.--An order under paragraph (1) shall provide the person subject to the order with an opportunity for an informal hearing, to be held not later than 10 days after the date of the issuance of the order, on the actions required by the order and on whether the order should be amended to require a recall of the drug involved. If, after providing an opportunity for such a hearing, the Secretary determines that inadequate grounds exist to support the actions required by the order, the Secretary shall vacate the order. ``(b) Order To Recall Drug.-- ``(1) In general.--If, after providing an opportunity for an informal hearing under subsection (a)(2), 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, except as provided in paragraphs (2) and (3), amend the order to require a recall. The Secretary shall specify a timetable in which the drug recall will occur and shall require periodic reports to the Secretary describing the progress of the recall. ``(2) Certain actions.--An amended order under paragraph (1)-- ``(A) shall not require recall of a drug from individuals; and ``(B) shall provide for notice to individuals subject to the risks associated with the use of the drug. ``(3) Assistance of health professionals.--In providing the notice required by paragraph (2)(B), the Secretary may use the assistance of health professionals who administered the drug involved to individuals or prescribed the drug for individuals. If a significant number of such individuals cannot be identified, the Secretary shall notify such individuals pursuant to section 705(b).''. SEC. 7. AUTHORITY TO ISSUE SUBPOENAS WITH RESPECT TO PREVENTING THREATS TO THE PUBLIC HEALTH. Section 303 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333(a)) is amended by adding at the end the following subsection: ``(h) The Secretary and the Attorney General shall develop and implement a procedure through which the Chief Counsel in the Food and Drug Administration is authorized to issue subpoenas regarding investigations under this Act of acts or omissions that may constitute a threat to the public health, including investigations of alleged violations to which paragraph (3) or (4) of subsection (a) apply and alleged violations with respect to which the Secretary is considering the use of authorities under section 304.''. <all>
Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Pages
▼
No comments:
Post a Comment