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 pharmacist in charge, 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?
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 (246-904 WAC) and ADDDs (246-874 WAC) for detailed information.
- What is the process for obtaining a HCE license?
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?
See fee rules: WAC 246-907-030(3)(g).
- How often are HCEs inspected?
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?
An HCE license requires the facility to have a pharmacist in charge who has the authority and responsibility to ensure that the area(s) within the health care entity where drugs are stored, compounded, delivered or dispensed are operated in compliance with all applicable state and federal statutes and regulations. The pharmacist in charge may be employed by the facility, or may be contracted.
- Is a RTF required to have an HCE license?
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. ADDDs are not permitted to be used by an RTF without an HCE license.
Automated Drug Distribution Devices (ADDD)
- What is an ADDD?
An ADDD is an automated device used for storage and use of medication used in patient care. These devices are linked to an electronic pharmacy patient records system. ADDDs can help improve patient safety and accountability and inventory of medications.
- Who can access an ADDD machine?
ADDD machines may be accessed only by health care providers whose scope of practice allows them to administer medications. This includes licensed practical nurses, registered nurses, advanced registered nurse practitioners, physician assistants, medical doctors, osteopathic physicians, naturopathic physicians, or pharmacists.
- Who can replenish an ADDD?
All ADDDs must be replenished by a licensed pharmacist or certified pharmacy technician under the supervision of a pharmacist. Additionally, a Washington state-licensed registered nurse or licensed practical nurse may replenish an ADDD if an electronic verification system is used.
- What is the process for registering an ADDD?
All pharmacies and non-resident pharmacies must provide written notice to the Commission on the Automated Drug Dispensing Device (ADDD) Location Form, and list the physical addresses of all locations where they service or manage ADDDs.
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. Read more about DEA registration.