Tag Archives: sterile compounding
Pharmacies that hold a permit in North Carolina and engage in any type of compounding are required to notify the North Carolina Board of Pharmacy (Board).
Pharmacies must report (both on their initial permit application and as part of each annual renewal) the following:
- Whether they compound;
- A good-faith estimate of the percentage of the pharmacy’s dispensing that involves compounded products;
- Whether the pharmacy engages in any non-sterile compounding;
- Whether the pharmacy engages in sterile compounding; and
- What risk level of sterile compounding, as defined by USP <797>, the pharmacy performs.
The Board published a guidance document to reduce any confusion about this reporting requirement.
Last month the Food and Drug Administration (FDA) alerted health care professionals and patients not to use drug products intended to be sterile that are produced and distributed by IV Specialty of Austin, Texas, due to lack of sterility assurance.
The FDA found numerous safety issues during its February 2016 which prompted them to recommend that IV Specialty (1) cease sterile production until appropriate corrective action are implemented and (2) recall all non-expired drug products intended to be sterile.
IV Specialty is a small pharmacy that reportedly only compounds in response to physician orders and does not provide medicines for office use or ship out of state. The FDA’s inspection report, Form 483, lists IV Speciality as a “Producer of Sterile Drug Products” and not as a licensed “Outsourcing Facility.” Therefore, some question whether the FDA has authority to force IV Specialty to halt production or issue a recall.
In response to the FDA alert a consumer advocacy group, Public Citizen, urged the Texas State Board of Pharmacy (Texas Board) to suspend IV Specialty’s compounders license since the FDA “uncovered multiple egregious, life-threatening problems in the company’s processes for making sterile drugs.”
In response to the FDA alert and Public Citizen’s pleas, the Texas Board sent one of its inspectors to IV Specialty and ultimately determined that there was not an immediate danger to the public or anything that would prompt the Texas Board to immediately close the pharmacy.
The Texas Board, however, acknowledged that while state regulations are not as stringent as FDA regulations, they are closely monitoring the case since the Texas Board recently issued five warning notices to IV Specialty for different violations. Additionally, the Texas Board has been in close contact with the FDA regarding their concerns.
As discussed previously on the Baer Law Blog, historically, state boards of pharmacy regulated compounding pharmacy. However, after the New England Compounding crisis of 2012, the Drug Quality and Security Act was passed and granted the FDA authority to inspect facilities and enforce regulations.
Figuring out how state and federal compounding rules and regulations are going to work together remains to be seen as sterile compounding regulations vary in many states.
Stay tuned to the Baer Law Blog for more updates on sterile compounding.