State Boards of Pharmacy (BOPs) have begun requesting very specific information from prescribing physicians about compounded medications. Pre-printed prescription pads and “office-use” are hot topics.
Your pharmacy’s compliance with state regulation is critical to business success. The BOP likely lacks direct jurisdiction over physicians, whose licenses are typically governed by state Boards of Medical Examiners (BME). However, the mere receipt of an investigatory document from a governmental authority can be disconcerting to physicians. When BOPs investigate physicians because of compliance issues, the physician relationship with your compound Pharmacy may be disrupted. The antidote to this business concern is Compliance with state laws.
The following are examples of some of the questions posed by the BOP:
- Pharmacy supplies your office with a pre-printed prescription pad listing the compounded products that you would prescribe for a patient. Once a prescription pad is completed with the patient’s name, name of drug, quantity, directions for use, signature and date, what does your office do with this? Please explain all scenarios that have taken place.
- After Pharmacy fills the compounded drug, how does the compounded product reach the patient? Are drugs sent to your office for patient pick up? If so, what is the process? Please explain
- If compounded products are sent to your [physician’s] office for patient pick up, please explain what is displayed on the outside of the prescription vial (if there is a label, what information is on this label?). Please explain.
- Has Pharmacy sent any of the compounded products to your office for “office use”? Please explain.
- What other ways do you prescribe compounded products for patients? (for example, do you use pre-printed prescription pads from other companies, use blank ones, etc.) Please explain.
- What are the percentage and the actual number of the prescriptions issued by your office using Pharmacy pads that are for patients residing in (STATE)?
Many of our pharmacy clients are licensed and registered in multiple states. State BOPs are focusing on “office use”, “pre-printed prescription pads” and state pharmacy licensing. When doing business in different states, your Pharmacy must comply with the “office-use” and “prescription pad” laws for each jurisdiction. Contact Frier Levitt to speak to an attorney about the requirements in your state.
