High Importance: US DEA to Begin enforcing an existing provision of federal law that requires all controlled substances to be shipped directly to the patient; Applies to Compounded Pain Pumps: Ohio Board of Pharmacy Provides Guidance

On May 8, 2014, the Ohio Board of Pharmacy issued the following notice:

Guidance Document: Access to Sterile Intrathecal Controlled Substance Compounds by Prescribers for Patients (Pain Pumps)



The United States Drug Enforcement Agency has recently informed the Ohio State Board of Pharmacy that it will begin enforcing an existing provision of federal law that requires all controlled substances to be shipped directly to the patient.
Overview of DEA Requirements
According to the DEA, Title 21 United States Code (U.S.C.) 802(10) requires that a pharmacy dispense a controlled substance ONLY to the ultimate user. Title 21 U.S.C. 802(27) defines ultimate user as "a person who has lawfully obtained, and who possesses, a controlled substance for his own use or for the use of a member of his household." Therefore, a pharmacy may not deliver a controlled substance to a prescribing practitioner in response to a prescription since the prescribing practitioner does not meet the definition of ultimate user.



It has come to the attention of the Board that the enforcement of this provision of federal law may present a patient safety issue as it pertains to intrathecal sterile compounds containing controlled substances (commonly referred to as pain pumps). These products are not commercially manufactured and compounding pharmacies are required to prepare these products. Currently, if this product is dispensed pursuant to a valid prescription (i.e. patient-specific) and shipped from the compounding pharmacy to the administering prescriber, it is considered by the DEA as a violation of federal law.
Overview of Ohio Requirements
The Ohio Administrative Code requires that a pick up station waiver be approved by the Board of Pharmacy if shipping patient-specific prescriptions (non-controlled) to a prescriber’s office, as explained in OAC 4729-5-10: http://codes.ohio.gov/oac/4729-5-10

Ohio allows for limited non-patient specific "wholesale" sales to occur by a pharmacy provided they meet the following regulations:

OAC 4729-9-10 http://codes.ohio.gov/oac/4729-9-10

Ohio regulations addressing compounding:

ORC 4729.01(C) http://codes.ohio.gov/orc/4729.01

OAC 4729-9-25 http://codes.ohio.gov/oac/4729-9-25 continue to read here