Wednesday, September 18, 2013

Protect My Meds Bullet Points of the Compounding Clarity Act of 2013, HR 3089


“Compounding Clarity Act of 2013.” Here are the bullet points.  How do you feel about these new proposals?

HR 3089 sets forth the following: 
  • Clear definitions that compounding within the patient-pharmacist-prescriber triad is legal and not subject to FDA oversight.
    • Part of this definition is: “The drug product is compounded by a licensed pharmacist in a State-licensed pharmacy or a Federal facility, or by a licensed physician, for an identified individual patient based on the receipt of a valid prescription.”
  • Allows for anticipatory compounding in limited quantities based on:
    • “Historical demand for the drug product” and
    • “A history of prescriptions for the drug product generated solely within an established relationship between” the compounder and “the individual patient” or the prescriber “who writes the prescription.”
  • Allows for compounding for office use, as long as the following criteria are met:
    • “The drug product will be administered by a health care practitioner within a physician’s office, a hospital, or another health care setting” and
    • “Valid patient-specific prescriptions” or “valid patient names” are submitted back to the compounder no later than seven business days after the drug was administered and
    • Account for the total volume of drug product dispensed for office use and
    • During any six month period, not more than 5% of total drug products dispensed from the facility are compounded sterile drug products and shipped interstate and
    • Records of compounding for office use are kept for not less than three years and
    • The statement “Office Use Only” and “Not for Resale” appears on the compounded drug product. 
    • Provides a good faith clause in which the pharmacy will not be found liable for prescribers who do not provide patient-specific prescriptions or valid patient names as long as the pharmacy does not continue to sell office use products to the facility.
  • The drug product must be compounded in compliance with USP chapters applicable to compounding (including sterile preparations).
  • Bulk drug substances (APIs) must meet one of the following criteria:
    • A USP/NF monograph exists and the API meets the requirements of the monograph or
    • Be a component of an FDA product  approved for human use or
    • Be listed on a list of approved APIs that the FDA develops for use in compounding.
    • All APIs must be manufactured in an FDA-registered facility.
  • “Ingredients (other than bulk drug substances)” must comply with an applicable USP or NF monograph.
  • FDA maintains a list of “Drug products withdrawn or removed because unsafe or not effective.”
  • Compounders cannot compound an essential copy of a “marketed and approved drug product” unless:
    • The drug product appears on the FDA drug shortage list or
    • The compound would produce a clinical difference for an individual patient as determined by the prescriber.
  • Allows the FDA to create a list of drug products that are “demonstrably difficult” for compounding.
  • Prohibits the act of wholesaling compounded drug products.
  • Sets up a regulatory framework in which the State Boards of Pharmacy shall communicate the following to the FDA:
    • Actions taken against compounding pharmacies by the Board, which include:
      • Issuance of warning letters, or State sanctions or penalties pertaining to compounding
      • Suspension or revocation of a license or registration
      • Recall of compounded drug product
    • Board concerns that a compounding pharmacy is acting in violation of the bill
    • Similarly, the FDA must notify the State Boards of Pharmacy if they receive a complaint regarding a pharmacy.
  • Sets forth inspection authority for the FDA over compounding pharmacy’s records if:
    • The inspection is performed in coordination with the Board of Pharmacy or
    • The FDA has evidence that the pharmacy may be in violation of the bill
  • Creates a new category of pharmacy called “Outsourcing Facility” that would be applicable only to pharmacies that compound sterile products for office use, shipped interstate, in excess of 5% of the total volume of compounded drugs in any six-month period.
    • Outsourcing Facilities are subject to cGMP regulations.
    • These facilities may not compound standardized dosages, from bulk substances, that are not otherwise commercially available copies of a marketed and approved drug product.
  • The bill considers repackaging as compounding and defines repackaging as taking an approved drug from the original container and placing the drug “in a different container of the same or smaller size without further manipulating the drug.”

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