In the past, I have discussed the recent passage of HR 3204, the Drug Quality and Security Act of 2013. I am still receiving calls from individuals who are confused with this law and how it affects their clinical practice. This federal legislation was enacted in response to the New England Compounding Pharmacy tragedy of 2012.
For informational background, I wish to comment on two sections of HR 3204. The first section, 503a, stipulates the following: “[…] applies to pharmacies engaged in sterile compounding, requires that active pharmaceutical ingredients must have a USP/NF monograph or an FDA approved drug.” This sounds reasonable; however, some pharmacies are utilizing non-FDA approved pharmaceuticals for certain clinical conditions.
In addition, the law states that some drugs cannot be compounded, such as preparations that are “difficult to compound.” At this time, there is no clear definition of “difficult to compound” and the government is in the process of developing a list of “difficult to compound” pharmaceuticals. Section 503a applies to pharmacies that compound patient-specific prescriptions, such as patient-specific intrathecal medications. Please note, however, that for pharmacies compounding patient-specific intrathecal medications, registration with the FDA is currently not a requirement. Rather, pharmacies that practice under this business model are regulated by their respective State Boards of Pharmacy.
The second section of HR 3204, section 503b, establishes “Outsourcing Facilities.” This is not necessarily a new term, and it refers to facilities that large institutions, such as hospitals, outsource for non-patient specific sterile compounded preparations. The FDA has recognized specialty pharmacy services that have been performing much like manufacturing for these large institutions dating back to 1995.
Over time, there have been pharmacies engaged in large-scale manufacturing that were not registered with the FDA. Therefore, in section 503b, the FDA established guidelines for what an outsourcing facility can provide. Outsourcing facilities can provide compounded sterile drugs without patient-specific prescriptions. To clarify, non-patient specific compounded prescriptions are usually intended for office supply or facility use – facilities such as hospitals and surgery centers. A physician may purchase 50 vials of a compounded sterile preparation for the treatment of his patients within his or her office.
It is important to note that section 503a relates to an individual patient, whereas section 503b affects numerous patients. Therefore, the parameters within 503b are stricter due to a higher risk of patient harm.
Under 503b, pharmacies must comply with continuous good manufacturing practices, also known as cGMP, and a pharmacist must supervise compounding. Outsourcing facilities must comply with specific labeling requirements, submit regular reports to the FDA, undergo inspections by the FDA, and report all adverse events to the FDA.
In summary, outsourcing facilities are legitimate entities to fill a void for large-scale institutions, especially in times of need. Outsourcing facilities can provide patient-specific and non patient-specific medications. Traditional pharmacies that may or may not register with the FDA can continue providing patient specific prescriptions pursuant to a valid prescription. As this relates to intrathecal drug therapy, traditional pharmacies can continue providing these medications to your practices without FDA oversight.
As a side note, this law does not affect any compounding of non-sterile prescriptions. Therefore, physician and clinics can obtain non-sterile compounded preparations regardless of their application.
With all federal and state regulations initially, there are a lot of “knowns” and “unknowns” at this time. There are many uncertainties within this law, and much will have to be determined (and clarified) over time by regulators and stakeholders.