Compound pharmacy business license considerations
Extensive license requirements
Currently, an in-state pharmacy license is required in all states and most states require a nonresident or mail order pharmacy license.
A separate controlled substance registration is required in many states in addition to a pharmacy license. A separate sterile compounding license is required in states such as California, Florida, Oklahoma, and Texas.
Considerable fees and long wait times
Pharmacy licensure is typically a 3-4 week long process at best, however, in some states, the process can take longer than several months. States with the lengthiest processing times are California, North Carolina, New Jersey, Ohio, Rhode Island, South Carolina, and Texas.
Obstacles to entry
Prerequisites to licensure also add up fast and can be a barrier to entry into the market if your pharmacy does not meet these initial requirements.
For example, in a number of states, the Pharmacist-in-Charge (“PIC”) must be licensed in that state. Seating a PIC can take time and adds to the cost of a pharmacy’s licensure. Some states also require the business to register, or foreign qualify, with the Secretary of State as a prerequisite to any pharmacy licensure.
Many states now require proof of compliance with USP 797 by either directly mentioning this requirement or making reference to USP 797. Another route to pharmacy compliance is to become accredited and certified by the Pharmacy Compounding Association Board (“PCAB”). This accreditation and certification may become a state-mandated compliance requirement.