Background
Before implementation of the health care entity (HCE) license, facilities without a pharmacy could buy, store, and handle prescription medications only through a prescribing provider who agreed to carry the risk and responsibility for the medications. The HCE license allows the facility to purchase, store, and administer prescription medications. Each HCE must designate a Washington-licensed pharmacist as a designated pharmacy manager, to ensure that the area(s) where drugs are stored, administered or dispensed are operated in compliance with all state and federal laws, rules and regulations. The risk and responsibility for the purchasing, storage, and administration of medications would lie with the facility rather than a provider. Since 2015, residential treatment facilities (RTFs) have been able to get an HCE license.
Health Care Entity (HCE) License
- What is the benefit of having an HCE license?
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The HCE license allows the facility to purchase store, and use legend drugs, including controlled substances when the facility is properly registered with the DEA, rather than a medical provider having to be responsible for medications. The HCE license also allows (but does not require) the RTF to use a licensed pharmacy to supply prescription medications. The RTF may also choose to use an automated drug dispensing device (ADDD) in accordance with WAC 246-874
See regulations for HCE licensing (246-945-245 WAC), Facility Standards WAC 246-945-410 or the Pharmacy Commission FAQ for detailed information.
- What is the process for obtaining a HCE license?
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The first step is to fill out the HCE application (PDF) in full and submit it along with the appropriate fee to the Department of Health. Once the application and fee are received and processed, a pharmacy investigator will schedule an initial inspection. When the inspection is complete and approved, the HCE license will be issued.
- How much does an HCE license cost?
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See fee rules: WAC 246-945-990.
- How often are HCEs inspected?
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HCEs are inspected before the initial HCE license being issued and may be subject to routine inspection by Department of Health.
- What is required to have an HCE license?
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An HCE license requires the facility to have a designated pharmacy manager.
- Is an RTF required to have an HCE license?
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No. However, prescription medications must be obtained through a medical provider who is responsible for the medications. Prescription medications must be purchased from a Washington licensed pharmaceutical wholesaler.
Drugs Stored Outside of the Pharmacy
In order for drugs to be stored in a designated area outside the pharmacy including, but not limited to, floor stock, in an emergency cabinet, in an emergency kit, or as emergency outpatient drug delivery from an emergency department at a registered institutional facility, the following conditions must be met:
(a) Drugs stored in such a manner shall remain under the control of, and be routinely monitored by, the supplying pharmacy;
(b) The supplying pharmacy shall develop and implement policies and procedures to prevent and detect unauthorized access, document drugs used, returned and wasted, and regular inventory procedures;
(c) Access must be limited to health care professionals licensed under the chapters specified in RCW 18.130.040 acting within their scope, and nursing students as provided in WAC 246-945-450;
(d) The area is appropriately equipped to ensure security and protection from diversion or tampering; and
(e) The facility is able to possess and store drugs
In order for the facility to obtain controlled substances, the facility must be licensed as an HCE with controlled substance authority. Once licensed as an HCE, the facility can then submit an application to the DEA to become registered. With an HCE license and DEA registration, the RTF may purchase and possess controlled substances.