FDA Responses to Action Items From March 18-19, 2015 Inter-governmental Working Meeting
1. FDA will consider the issues that states described as possible impediments to signing an MOU and aspects of the draft MOU that were identified as needing further clarification. States will also submit these issues as comments to the open docket.
- Some states plan to inspect outsourcing facilities against USP <797> although outsourcing facilities registered with FDA under section 503B are required to comply with FDA’s current good manufacturing practice (CGMP) requirements. Most states are accustomed to inspecting against USP <797> standards, but this could cause confusion and issues for the facilities and the public.797>797>
- States are licensing outsourcing facilities in different ways, although most states (60%) have either created a category of outsourcing facility or have under consideration legislation to create such a category.
Some states are licensing them under the category “wholesalers”. This can cause confusion because one of the conditions under section 503B is a prohibition on wholesaling:
``(8) Prohibition on wholesaling.--The drug will not be sold or transferred by an entity other than the outsourcing facility that compounded such drug. This paragraph does not prohibit administration of a drug in a health care setting or dispensing a drug pursuant to a prescription executed in accordance with section 503(b)(1).”
In addition, the labeling for products compounded by an outsourcing facility must include:
``(IX) the statement `Not for resale', and, if the drug is dispensed or distributed other than pursuant to a prescription for an individual identified patient, the statement `Office Use Only'”.
- Ten states indicated they require an outsourcing facility to have a pharmacy license if they are dispensing pursuant to patient specific prescriptions; 8 states indicated they require a pharmacy license but do not specify whether this is in all cases or only if the outsourcing facility is also dispensing pursuant to prescriptions; 10 states indicate that they do not require pharmacy licenses for outsourcing facilities. We had heard but were unable to confirm through the survey that some states will not provide a pharmacy license to an outsourcing facility.
- One state requires an outsourcing facility to dispense only pursuant to patient-specific prescriptions, which is inconsistent with the business model of most outsourcing facilities.
- Five states said that they do not license outsourcing facilities, but did not further explain their answer.
- FDA will continue to discuss with the states and NABP ways to resolve these inconsistencies.