![]() ![]() All comments should be identified with the docket number found in brackets in the heading of this document. Submit written comments on the final standard MOU to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. Submit electronic comments on the final standard MOU to Docket No. FDA is withdrawing its revised draft standard MOU that published on Septem( 83 FR 45631), as of October 27, 2020. The announcement of the MOU is published in the Federal Register on October 27, 2020. The final standard MOU describes the responsibilities of a State Board of Pharmacy or other appropriate State agency that chooses to sign the MOU in investigating and responding to complaints related to drug products compounded in such State and distributed outside such State and in addressing the interstate distribution of inordinate amounts of compounded human drug products. Food and Drug Administration” (final standard MOU). The Food and Drug Administration (FDA or the Agency) is announcing the availability of a final standard memorandum of understanding (MOU) entitled “Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products Between the and the U.S. Enforcement of the 5 Percent Limit on Distribution of Compounded Human Drug Products Out of the State in Which They Are Compoundedįood and Drug Administration, HHS. Information Sharing Between the State Boards of Pharmacy or Other Appropriate State Agencies and FDA Exemptions From the Provisions Related to Distribution of Inordinate Amounts of Compounded Human Drug Products Interstate Authority of State Boards of Pharmacy or Other Appropriate State Agencies Distribution of Inordinate Amounts of Compounded Human Drug Products Interstate Investigation of Complaints Relating to Compounded Human Drug Products Distributed Outside the State Previous Efforts To Develop a Standard MOU This repetition of headings to form internal navigation links Headings within the legal text of Federal Register documents. This table of contents is a navigational tool, processed from the Provide legal notice to the public or judicial notice to the courts. Rendition of the daily Federal Register on does not Until the ACFR grants it official status, the XML ![]() Legal research should verify their results against an official edition of ![]() The official SGML-based PDF version on, those relying on it for The material on is accurately displayed, consistent with While every effort has been made to ensure that ![]() Regulatory information on with the objective ofĮstablishing the XML-based Federal Register as an ACFR-sanctioned The OFR/GPO partnership is committed to presenting accurate and reliable Register (ACFR) issues a regulation granting it official legal status.įor complete information about, and access to, our official publications Informational resource until the Administrative Committee of the Federal This prototype edition of theĭaily Federal Register on will remain an unofficial Each document posted on the site includes a link to theĬorresponding official PDF file on. The documents posted on this site are XML renditions of published Federal Register, and does not replace the official print version or the official It is not an official legal edition of the Federal This site displays a prototype of a “Web 2.0” version of the dailyįederal Register. ![]()
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