“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:
- 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- FDA maintains a list of “Drug products withdrawn or removed because unsafe or not effective.”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.
- Actions taken against compounding
- 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.”Quoted From ProtectMyCompounds.com
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