Keystone Laboratory administrative offices will be closed on Monday, September 4th to honor and observe Labor Day. We will resume our normal business hours on Tuesday, September 5th.
June 9, 2023
Have Any Questions?
The US government should have strict regulations in place to ensure the safe prescribing of controlled substances. However, these regulations are pretty much non-resistant. The US government does not require doctors to take drug testing. (1) However, these tests could be mandated by the physicians’ employer. It would make sense that there be regulations requiring all doctors who prescribe controlled substances to pass drug tests and submit to the necessary background checks. But there aren’t any federal regulations on such things.
When deciding whether or not a medical professional is qualified to administer, prescribe or dispense controlled medications, the Drug Enforcement Administration (DEA) looks to state licensing boards for guidance. The boards also decide which dosages can be administered, supplied, and prescribed. (2)
Some states also mandate controlled substance reports (CSRs) for healthcare and medical practitioners and those who handle controlled substances in addition to professional licenses.
Individuals who work with controlled substances may be required to register with the state prescription monitoring program (PMP) even if the state does not have a separate CSR requirement. This helps the state keep tabs on prescription and dispensing activity and detect any signs of abuse. (2)
Physicians that offer controlled substances to patients will need to be registered with the DEA.
To legally produce, distribute, import, export, or dispense restricted substances, businesses and practitioners must register with the DEA for each site where such activities will take place.
You can sign up and renew your registration on the website (effective May 22, 2022). We will go more in-depth on this later.
A pharmacy that wants to export-prohibited medications must register as an exporter with the DEA every year using Form 225. There is a yearly renewal fee and a 4-6 week application processing time. The average cost is about $1,500. (2)
In order to store, deliver, and receive restricted drugs and administer them to patients en route to a medical facility, EMS, or emergency medical services, one must register with the DEA. The registration can also be used as evidence that the group is legally permitted to offer services in the state on a federal level. A single registration covers each distinct EMS facility in a state. (A separate registration form is not required for each location.)
The following are requirements that an EMS provider must meet in order to be in accordance with federal regulations:
While discussing the various needs for handling controlled medications, we have not discussed what those medications are.
Controlled medications are drugs or chemicals regulated by the government for medical, scientific, or industrial purposes. The US government regulates controlled substances through the Controlled Substances Act (CSA). The CSA places these drugs into five categories – Schedule I, II, III, IV, and V – based on their potential for abuse and addiction. Schedule V drugs have the lowest potential for abuse and are accepted for medical use. However, Schedule I drugs have a high potential for abuse and are not accepted for medical purposes.
Go to www.deadiversion.usdoj.gov to submit an application. Be sure to write down the control number from your online application. After one business day, you can check the status of your application online (by selecting “Check the Status of My Application”) and make any necessary changes. You can also check the status of your application by dialing 800.882.9539. The following are required for a status check:
Applicants for DEA registration must show proof of a current license from the state in which they intend to work. In addition to obtaining or applying for federal DEA registration or renewal, you may also need to obtain a state-controlled substance permit (required by roughly half of the states). (3)
Registration with the DEA lasts for three years. A renewal letter for your DEA registration will be mailed to the address listed on your current registration around 60 days before it expires.
It would be best if you informed the DEA of your new address whenever it changes. You can do this by contacting the DEA at 800.882.9539 and selecting “Change Your Address” from the menu or going online and selecting “Make Changes to My DEA Registration” from the main menu.
To update your DEA, you’ll need the control number, your full name, SSN, the address where you currently reside, and the date it expires. Your letter renewing your DEA will not be forwarded by the post office. The renewal letter for your DEA registration will be mailed to the address you provided when you submitted your registration as an intern or resident. After completing your DEA training, be sure to update the agency about your whereabouts. (3)
Upon receipt of the renewal letter, proceed immediately to renew your subscription in its entirety via the provided online portal. Keep in mind that the DEA can take anywhere from four to six weeks (online) to eight to twelve weeks (by mail) to process your renewal. When renewing your DEA, you have until the expiration date plus 30 days to complete the process. To administer, dispense, or prescribe restricted substances before receiving your renewal license would be illegal. (3)
Make sure you include the correct amount for the application fee when you submit it. The DEA will not process your renewal paperwork if you do not provide the correct fee.
Keystone Laboratories, a CAP-accredited North Carolina licensed laboratory and CLIA-licensed lab, is committed to helping you make important decisions that impact the safety and health of your patients with greater confidence. Clients in 48 states can get prescription drug and substance abuse recovery monitoring, specialized testing, workplace drug testing, screening, and program management services from Keystone. Contact Keystone Laboratories today to receive the industry-leading laboratory testing services!