Ensure Your Use of Pre-Printed Prescription Pads is Compliant

Recently, more and more pharmacies are making use of pre-printed prescription pads, which they provide to physicians’ offices as a guide for common-prescribed compounded formulations. However, in utilizing these pre-printed forms, pharmacies must be careful not to run afoul of State and Federal laws and regulations, as well the PBM manuals.

First, pre-printed pads must comply with State law in the States where the prescription is written, filled and dispensed. In this regard, certain States have statutorily-required prescription pads, and as a result, pre-printed compound prescription pads may not be allowed whatsoever. Other States have laws that specifically prohibit the use of pre-printed prescription pad with controlled substances. Recently, New Jersey passed a law amending its requirements for tamper-proof prescription pads, and this new law specifically addressed pre-printed prescriptions.

Second, under the Federal Controlled Substances Act and DEA regulations, there may be limitations as to whether pre-printed prescription pads can be used for controlled substances. A recent DEA opinion letter stated that pharmacies cannot prepopulate prescriptions with patient names for controlled substances. Certain State Boards of Pharmacy have interpreted this to mean that prescriptions with controlled substances pre-printed on them are prohibited, even if the prescription does not have any patient demographics on it.

In light of this issue, certain payors have incorporated this position into their manuals, stating that pharmacies may not produce, distribute, or accept pre-printedor pre-populated prescriptions for controlled substances. Based on this, certain PBMs are auditing pharmacies, recouping monies, and terminating pharmacy contracts for accepting or distributing such prescription pads. For advice on whether your pads comply with State and Federal law, contact Frier Levitt.  We can review your pads, as well as other marketing material, to ensure compliance.

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