Pharmacy Board Frequently Asked Questions

The following is for informational purposes only.  This does not and should not be construed as official legal advice or policy from the Indiana Board of Pharmacy.  Always review any state or federal regulations that may help answer your question, and if needed seek private counsel.  The Board is unable to provide specific legal advice.   This was last updated March 8, 2019.

USP 800

Required Prescription Elements

Prescription Paper
Out-of-State Prescriptions
Change of Ownership

Does the Indiana Board of Pharmacy require compliance with USP 800?

USP 800 is a standard developed by the United States Pharmacopeia and becomes effective December 1, 2019.  USP is not a regulatory body.  This means that the standards they develop are not legal requirements.  Their standards only become a legal requirement if the standards are adopted as state or federal law.  At this time, the Indiana Board of Pharmacy has not adopted USP 800, and legislation has not been introduced in the Indiana General Assembly either. If either occurs, the Indiana Board of Pharmacy will provide notice to all licensed pharmacies in the state. However, beware that other organizations, such as accrediting bodies, may require USP 800. It is best to consult with your private counsel to determine if any regulating body overseeing your operations requires compliance with USP 800.

What are the required elements of a prescription?

Under Indiana law, all prescriptions must have the following information:

• Name and address of the patient
• Name and strength or size of the drug or device
• Amount to be dispensed
• Adequate directions for the proper use of the drug or device by the patient
• Name of the practitioner
• Issued and signed by a practitioner, either in writing or electronically

See IC 16-42-19-7.

Additionally, all controlled substance prescriptions must also have the following information:

• Dated as of, and signed, the day when issued
• Name, address, and federal controlled substance registration number of the practitioner

See 856 IAC 2-6-4

Can a pharmacy accept a prescription that is printed on plain paper?

Yes, provided all the required elements of a prescription are present.  However, the answer is no if the prescription is for a controlled substance.  All non-electronic prescriptions for a controlled substance must be printed on security paper that has been approved by the Indiana Board of Pharmacy.  A list of current approved security prescription paper providers can be found here: https://www.in.gov/pla/2538.htm.

Prescriptions utilized by pharmacists to record call-in prescriptions, transferred prescriptions, or facsimile prescriptions do not need to use security prescription paper.

Finally, the name of a controlled substance may not be preprinted on any prescription at any time before the prescription is being prepared and executed.  That includes such activities as typing prescriptions in anticipation of their need, or using a rubber stamp to accomplish the same end.  Commercially printed forms containing names of controlled substances are also prohibited.

See 856 IAC 1-34.

Can our pharmacy fill prescriptions written by physician assistants and nurse practitioners in another state?

Yes.  A pharmacist may fill a prescription written by an out-of-state provider, provided they are licensed in that state, and the pharmacist has taken reasonable steps to determine whether the prescription was issued in compliance with the laws of the state where it originated. 

See IC 25-26-13-16

What constitutes a change of ownership of a licensed facility?

Pharmacy permits cannot be transferred between locations or owners.  If there is a change of ownership, an application for change of ownership should be made no later than 10 days after the change in ownership.  The original permit will remain valid until a new permit is issued or the application is rejected. 

Whether or not a change of ownership has occurred must be determined by the facility.  The ultimate inquiry is whether there has been a change in who has control over the operations of the facility.  Things to consider include a change in corporate identity, a change in a parent organization or a change of legal tax identification number.  A change of officers does not constitute a change of ownership if the corporate structure remains the same.  If in doubt, it best to obtain a new permit.  

Further information on changes of ownership, location, or officers can be found here: https://www.in.gov/pla/2992.htm.

See IC 25-26-13-21.