Compounding Regulations
With the recent tragedy of the meningitis outbreak originating
from the New England Compounding Center in Massachusetts,
the topic of compounding pharmacy practice and regulatory issues has
been brought to the forefront on both a federal and state level. On the
federal level, it remains to be seen what changes or
legislation will be identified in response to this tragedy. The state
boards of pharmacy and Food and Drug Administration (FDA)
have identified a lack of clear definition of what constitutes a
manufacturer versus a compounding pharmacy.
The North Dakota State Board of Pharmacy feels that there
is a need to have this clear definition to ensure there will be the
proper regulatory framework to provide oversight over each of
these industries. Out of this tragedy, the Board wants to provide
a reminder for its licensees of the laws and rules that are specific
to compounding.
♦ Compounding should be done pursuant to a patient-specific prescription.
The Board allows you to make batches of a compounded product but only
pursuant to a likely need.
♦ North Dakota law allows you to compound for “office
use” for practitioners. The Board requires the pharmacist
to ensure the product will only be used within the office
setting and not dispensed by the practitioner to the patient.
♦ The Board recently passed rules that closely mirror United
States Pharmacopeia Chapters 795 and 797 standards. Be
sure that you look at these, which go into effect in January 2015, to
ensure your pharmacy is compliant at that time pursuant to the compounding
activities that your pharmacy is engaged in.
♦ Maintain a compounding log of each of the prescriptions
being formulated. Keep the records for five years.
The Board is not looking to make any changes to the current
laws and rules currently governing compounding pharmacies at
this time. Future inspections at in-state pharmacies who engage in
compounding activities will be more detailed and comprehensive.
The Board will be looking at solutions to address the quality
assurance and inspections of out-of-state compounding pharmacies
to ensure proper procedures and safeguards are consistent
for a high level of patient care for North Dakota residents. The
Board may look to work with the National Association of Boards
of Pharmacy® and their current inspection process for compounding pharmacies
as a potential solution.
Board Discusses OTC Compounding
During the most recent Board meeting, discussion was had on
how to regulate over-the-counter (OTC) compounding in North
Dakota. Board members expressed the desire to continue for the
Board staff to see labels on those OTC drug products that pharmacies
compound to ensure that proper material is contained on
the label so a patient is properly educated on the product. Board
members felt labeling similar to the current structure from the
Federal Trade Commission is necessary
Source North Dakota Board of Pharmacy March 2013 Newsletter