4 Controlled Substance Laws and Regulations You Should Know

JULY 24, 2017
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
  • Date prescription was issued
  • Prescriber’s signature
  • Patient’s full name and address
  • Medication name
  • Strength
  • Dosage form
  • Quantity prescribed
  • Directions for use
  • Prescriber’s name, address, and registration number.
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
  • The quantity prescribed and dispensed must be limited to an adequate amount to treat the patient during the emergency.
  • The pharmacist must document the oral prescription information and verify the identity of the prescribing practitioner.
  • The pharmacy must receive the written prescription within 7 days, and it must state on the face “Authorization for Emergency Dispensing” with the date of the oral order.
  • The pharmacist must attach the paper prescription to the emergency oral authorization.  Pharmacists must document electronic prescriptions with the original authorization and date of the oral order.
  • Pharmacists must notify the Drug Enforcement Administration if a prescriber fails to deliver the written or electronic prescription on time.
 
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.

References
  1. Boards of pharmacy.  NABP website.  https://nabp.pharmacy/boards-of-pharmacy/.  Accessed July 21, 2017.
  2. Title 21 Code of Federal Regulations 1306.05 manner of issuance of prescriptions.  DEA website.  https://www.deadiversion.usdoj.gov/21cfr/cfr/1306/1306_05.htm.  Accessed July 23, 2017.
  3. Title 21 Code of Federal Regulations 1306.22 refilling of prescriptions.  DEA website.  https://www.deadiversion.usdoj.gov/21cfr/cfr/1306/1306_22.htm.  Accessed July 23, 2017.
  4. Title 21 Code of Federal Regulations 1306.04 purpose of issue of prescription.  DEA website.  https://www.deadiversion.usdoj.gov/21cfr/cfr/1306/1306_04.htm.  Accessed July 23, 2017.
  5. Governor Eric Greitens announces statewide prescription drug monitoring program.  Missouri Governor website.  https://governor.mo.gov/news/archive/governor-eric-greitens-announces-statewide-prescription-drug-monitoring-program.  Accessed July 23, 2017.
  6. Status of PMP’s.  PDMP TTAC website.  http://www.pdmpassist.org/pdf/pdmpstatustable.pdf.  Accessed July 23, 2017.
  7. Title 21 Code of Federal Regulations 1306.11 requirement of prescription.  DEA website.  https://www.deadiversion.usdoj.gov/21cfr/cfr/1306/1306_11.htm.  Accessed July 23, 2017.


Jennifer Gershman, PharmD, CPh
Jennifer Gershman, PharmD, CPh
Jennifer Gershman, PharmD, CPh, received her PharmD degree from Nova Southeastern University (NSU) College of Pharmacy in 2006 and completed a 2-year drug information residency. She served as a pharmacy professor at NSU’s College of Pharmacy for 6 years, managed the drug information center, and conducted medication therapy management reviews. Dr. Gershman has published research on prescription drug abuse, regulatory issues, and drug information in various scholarly journals. Additionally, she received the Sheriff’s Special Recognition Award for her collaboration with the Broward, Florida Sheriff’s Office to prevent prescription drug abuse through a drug disposal program. She has also presented at pharmacist and physician continuing education programs on topics that include medication errors, prescription drug abuse, and legal and regulatory issues. Dr. Gershman can be followed on Twitter @jgershman2
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