Sunday, June 30, 2013

IACP's Latest (June 27, 2013) Summary on the Senate HELP Committee Version of the Compounding Bill--and Copy of Latest Draft

Senate Releases Revised Compounding Bill, Today

The Senate has just released its revised version of the Compounding Bill. Please click here to review. The IACP Legislative Team currently is reviewing this Bill line-by-line, and will provide a comprehensive report as soon as completed. Please see IACP's initial comments below:
Initial Summary
The language in S. 959 released on Thursday, 27 June 2013 includes the following:
  • A definition that all compounded drugs are "new drugs" as defined within the FDCA (page 57)
  • Defines the repackaging and distribution in interstate commerce of sterile drugs without individual patient prescriptions as the activities of a "compounding manufacturer." (page 59)
  • Provides for anticipatory compounding only in instances where the historical volume is directly associated with an individual patient prescription (page 64)
  • Hospitals and health-systems with wholly owned inpatient and outpatient facilities are exempted from being considered compounding manufacturers even if they ship interstate (page 66)
  • Traditional compounding is exempted from the "new drug" requirements of an NDA/ANDA and the AERS if the pharmacy is in full compliance with this section of the law as well as state law. (page 66)
  • The FDA may develop a "do not compound" list based upon "demonstrably difficult" criteria (which is undefined).  (pages 68/69)
  • The FDA may develop a "do not compound" list for drugs which are currently under a REMS when produced by manufacturers (page 69)
  • Compounding of "commercially available" products are restricted to "documented clinical differences" for an individual identified patient or, if in drug shortage, subject to a 3 day notification to the FDA requirement (page 72-74)
  • Compounding manufacturers who are preparing drugs that are in shortage must notify the FDA 14 days in advance before preparing any compounds.  (page 73)
  • The repackaging of a currently marketed drug into a format/dosage form that is also currently marketed (e.g., Avastin and Lucentis) is prohibited.  (page 74)
  • Prior to compounding a medication under REMS may only be done so with prior advance proof and submission to the FDA that the pharmacy is capable of meeting the REMS requirements (page 77)
  • API-based compounding must still be upon the existence of a monograph or when using a drug product that appears on a list to be established by the FDA.  No mention is made of other nationally recognized compendia (e.g., homeopathic medicines).  (Page 77)
  • The FDA is empowered to prohibit the compounding of a preparation with an API-based ingredient even if there is a monograph published in the FDA (Page 80)
  • The GAO will prepare an analysis and report on veterinary compounding. (page 106)
  • False and misleading advertisements of a compounded preparation by either a traditional compounder or manufacturer has defined penalties (107)
References to compliance with USP standards that appeared in an earlier draft have been removed.  No language provided by IACP to preserve the ability of prescribers to order "office-use" medications was included.
quoted from here

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