Everything from registering with the DEA to disposing controlled substances is governed by forms. Know the different forms and their use along with the mandate of physical signatures on prescriptions.
Controlled substances are drugs that are used as analgesics, anesthetics, steroids and even euthanasia solutions in special situations. They are stringently regulated by law given their potential for misuse, abuse and dependence. It follows that strict controlled substance regulations have been put in place by the Controlled Substances Act.
These substances cannot be prescribed, administered, dispensed or even handled without a valid license and registration from the DEA (Drug Enforcement Administration). In fact, this federal agency has prescribed a string of forms to control every aspect of operations related to controlled substances. The primary ones are:
- Form 224 is used by healthcare providers, hospitals, clinics, pharmacies, etc. for registering with the DEA.
- Manufacturers, distributors, exporters and importers have to register by way of Form 225.
- Form 323 is reserved for registering narcotic treatment programs.
- The same form number suffixed with an ‘a’ is used for renewing the registration – like Form 224a, Form 225a, etc.
- Form 222 is used for ordering Schedule I and II controlled substances. It is also used for transferring the said drugs from one location to another.
- Form 106 serves as the format for reporting theft or loss of controlled substances to the DEA
- Form 41 is to be used as an inventory of surrendered/destroyed controlled substances
In addition to this, the DEA mandates that all paper prescriptions of controlled substances should always be signed manually by the prescribing practitioner. This is applicable to prescriptions written on paper as well as those generated by computer and printed on paper. It further extends to those that have been faxed by a practitioner. In fact, prescriptions will be considered valid only when there is a manual signature of a DEA-registered practitioner (or a practitioner exempt from the requirement of registration).
However, the rules are a little lax when it comes to Schedule III, IV and V substances. These can be dispensed by a pharmacist based on an ‘an oral prescription made by an individual practitioner and promptly reduced to writing by the pharmacist containing all information required except for the signature of the practitioner’.
This does not extend to Schedule II drugs as they are considered more dangerous in the wrong hands. Therefore, they require a written prescription signed by the practitioner, except in emergency situations when an oral prescription is permitted.
All said and done, DEA registrants have to walk a fine line when it comes to prescribing, dispensing or even handling the controlled substances. They should know each form – like say, DEA form 222 – and its use. These should be used in the correct manner at all times. Additionally, they should also follow all the other applicable rules as any kind of non-compliance can invite the wrath of the law. And the fallout can be extremely harrowing – ranging from loss of registration to even judicial proceedings!
