What happens if any requirement for limited compounding of controlled substances is not met?

When a requirement for limited compounding of controlled substances is not met, it generally leads to the need for a separate registration as a distributor. This distinction arises from the fact that compounding and distributing are regulated differently under the law. If a pharmacy exceeds the defined limits for compounding controlled substances, it crosses into the realm of distribution, requiring compliance with additional regulations and the appropriate registration.

This is important for maintaining regulatory standards and ensuring that pharmacies do not inadvertently engage in activities that may subject them to stricter scrutiny or enforcement actions.

In the context of other options, compounding may not be permanently banned; it is more a matter of regulatory compliance. Adjusting only the product does not address the issue of registration or compliance with broader distribution regulations. Likewise, compounding under supervision is not a standard requirement tied to failing to meet compounding criteria, but rather is typically related to specific situations or protocols within the pharmacy practice. Thus, the correct response highlights the necessity of maintaining appropriate registrations based on the activities being conducted.