Pharmacists have a great responsibility to stay current with the laws and regulations governing the profession.
Pharmacists have a great responsibility to stay current with the laws and regulations governing the profession. The Controlled Substances Act (CSA) places all regulated substances under existing federal law into 1 of 5 schedules. Additionally, it outlines manufacturing, dispensing, and distributor requirements such as record keeping provisions.
It is important to note that states may establish stricter laws than the CSA, and pharmacists must keep abreast of the information. State boards of pharmacy also may require that electronic or print copies of the current laws and regulations be maintained in the practice setting, which is especially important when it comes to inspections. If you are in search of your state laws, then look no further than the National Association of Boards of Pharmacy, which maintains links to the state boards of pharmacy websites.1
Controlled substance prescriptions have specific requirements.
All prescriptions for controlled substances must include the following:2
Pharmacists should consult their state rules to determine whether other prescription requirements exist.
Schedule III and IV controlled substances expire after 6 months.
Schedule III and IV controlled substances cannot be filled or refilled more than 5 times or more than 6 months after the date the prescription was issued, whichever occurs first.3 Schedule II prescriptions cannot be refilled. Under federal law, there is no expiration for a Schedule II prescription. However, many states have established time restrictions. In states with no expiration this becomes a tricky situation and the pharmacist’s professional judgement is extremely important.
Pharmacists have a corresponding responsibility.
Prescriptions must be issued for a legitimate medical purpose, and pharmacists have a corresponding responsibility to determine this when dispensing controlled substances.4 Essentially, this means that pharmacists must use their professional judgement and verify controlled substance prescriptions. Pharmacists should consult their state prescription drug monitoring program (PDMP) when verifying controlled substance prescriptions. Missouri has just become the last state to enact legislature to establish a PDMP, as the governor recently signed an executive order.5 Currently, 49 states, the District of Columbia, and Guam have operational PDMPs.6
Schedule II controlled substances can be dispensed through an oral prescription for emergencies.
The following requirements must be followed when dispensing Schedule II controlled substances for emergency situations:7
Pharmacists should consult their state laws and regulations to determine if there are more stringent requirements for emergency Schedule II oral prescriptions.
Hopefully, these laws will assist you in your pharmacy practice setting and serve as a starting point for your pharmacy law toolbox.