H.4487 eliminates the registration renewal grace periods for all registrations to manufacture, distribute, or dispense controlled substances. DHEC is mailing out flyers to notify registrants about the elimination of the grace period prior to their next renewal cycle.
H.3826 requires written prescriptions for controlled substances to be written on tamper-resistant prescription pads, with exceptions. Prescription orders transmitted by facsimile, orally, or electronically are exempt from the tamper-resistant prescription pad requirements. This act is effective July 16, 2018.
- Guidance on tamper-resistant prescription pads from the National Council for Prescription Drug Programs (NCPDP) is available here. The NCPCP issued the guidance in 2008 to clarify Medicaid requirements that are consistent with the requirements of H.3826.
S.918 establishes limitations for initial opioid prescriptions, such that initial opioid prescriptions for acute pain management or postoperative pain management must not exceed a seven-day supply, except when clinically indicated for cancer pain, chronic pain, hospice care, palliative care, major trauma, major surgery, treatment of sickle cell disease, treatment of neonatal abstinence syndrome, or medication-assisted treatment for substance use disorder.
- Prescribing practitioners must ensure that any initial opioid prescriptions for acute or postoperative pain management that exceed a seven-day supply are clinically indicated in order to comply with the S.C. Controlled Substances Act.
- Though corresponding liability rests with pharmacists who fill and ultimately dispense the prescription, pharmacists are not obligated to verify compliance. However, pharmacies may choose to implement their own verification procedures for prescriptions in accordance with the requirements of S.C. Pharmacy Practice Act.
- Pharmacists continue to have the authority under state law to refuse to fill a prescription if they are concerned about the “legitimate” nature of the prescription.
S.918, in addition to establishing the abovementioned limitations for initial opioid prescriptions, requires DHEC to develop and maintain as part of the PMP a system to provide prescription report cards to practitioners to inform the practitioner about certain prescribing trends. Although DHEC currently provides prescription report cards to practitioners, the new law requires the report cards to provide a different set of metrics to practitioners beginning November 15, 2018.
H.4117 authorizes DHEC’s Drug Control to provide data in the PMP to the presiding judge of a drug court pertaining to a specific case involving a designated person.
H.4488 authorizes DHEC’s Drug Control to provide data in the PMP to a coroner, deputy coroner, medical examiner, or deputy medical examiner who is involved in a specific inquiry into the cause and manner of death of a designated person pursuant to Chapter 5, Title 17.
S.345 revises the prescriptive authority of certain advanced practice registered nurses with respect to controlled substances and authorizes physician assistants to perform telemedicine to include authorized prescribing of Schedule II and Schedule III prescriptions. This act is effective July 1, 2018.
- The drug schedules listed on a current DHEC controlled substances registration can be changed by submitting the Schedule Change Request form to firstname.lastname@example.org.
This information is not intended to be a comprehensive summary of the recently enacted laws and should not be relied upon as legal advice. It is the responsibility of all entities subject to Chapter 53, Title 44 of the South Carolina Code of Laws to verify their own compliance with that chapter and with all other applicable federal, state, and local laws and regulations.