On August 22, 2014, the Administrator of the Drug Enforcement Administration (DEA) published their Final Rule rescheduling hydrocodone combination products from schedule III to schedule II of the Controlled Substances Act. This action imposes the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule II controlled substances on persons who handle (manufacture, distribute, dispense, import, export, engage in research, conduct instructional activities with, conduct chemical analysis with, or possess) or propose to handle hydrocodone combination products.
The Tennessee Pharmacists Association, along with numerous other state and national partners, provided official comments to the DEA voicing concern over this Final Rule and rescheduling hydrocodone combination products (HCPs). In particular, TPA voiced concern about decreased access to care for patients with legitimate pain management needs, the potential safety and security concerns regarding increased risk for robbery and burglary for our pharmacists, pharmacy staff members, and patients, and the increased administrative and regulatory burden on pharmacists and other health care providers.
Despite receiving numerous concerns, the DEA has elected to move forward with this Final Rule, which will become effective on October 6, 2014.
The following information has been provided to TPA by Pharmacy Audit Assistance Service (PAAS) in order to assist pharmacies in complying with this Final Rule:
- Handling: On or after October 6, 2014, any person who handles HCPs will be required to do so in compliance with all associated rules and regulations for Schedule C-II drugs.
- Package Labeling: On or after October 6, 2014, all wholesalers will be required to distribute only HCPs labeled as Schedule C-II drugs.
- Dispensing from Schedule C-III Packages: Pharmacies are permitted to dispense HCPs from their inventory on hand in the old Schedule C-III packaging on or after October 6, 2014. However, all dispensing on or after October 6, 2014, must be in accordance with all state and federal rules and regulations for Schedule C-II medications.
- HCP Prescriptions with Refills Remaining: If a prescription for an HCP is issued before October 6, 2014, and authorizes refills, the refills may be dispensed as long as they occur prior to April 8, 2015. All prescriptions written on or after October 6, 2014, are Schedule C-II and must comply in all respects including no refills. As a reminder, Tennessee law does not permit dispensing of opioid prescriptions in quantities greater than a 30 day supply. The DEA did not provide further guidance on this issue, which leaves several unanswered questions at this time. Some questions remaining include further clarification regarding the issuance date of the prescription, physician back-dating of prescriptions, and transfer of prescription refills.
- NDC Questions: Whether or not manufacturers will replace the C-III HCP package NDC numbers with new C-II NDCs remains unclear. If replaced, this could cause billing confusion for pharmacies and could potentially cause conflicts with current pharmacy software systems and refills of HCPs.
- Security/Storage: Pharmacies will need to store HCPs in accordance with all state and federal regulations pertaining to C-II prescriptions on or after October 6, 2014. The DEA does not currently require that Schedule C-II medications be stored in safes or vaults, although many pharmacies do so. Current DEA rules and regulations do permit Schedule C-II medications to be dispersed throughout the pharmacy.
- Pharmacy Practice Sites Operating Under TN Board Rule 1140-03 (Community Pharmacy Practice Sites): The Tennessee Board of Pharmacy rules do not specify additional storage requirements above those contained in the Code of Federal Regulations, Title 21, Part 1301.75, which states that “(b) Controlled substances listed in Schedules II, III, IV, and V shall be stored in a securely locked, substantially constructed cabinet. However, pharmacies and institutional practitioners may disperse such substances throughout the stock of non-controlled substances in such a manner as to obstruct the theft or diversion of the controlled substances.” Click here for Part 1301.75 of the Code of Federal Regulations.
- Pharmacy Practice Sites Operating According to TN Board Rule 1140-04 (Institutional and Alternate or Alternative Site Infusion Pharmacy Practice Sites): Tennessee Board Rule 1140-04-.08 (3) states that “Schedule II Controlled Substances which are kept within a pharmacy practice site shall be stored in a secured, substantially constructed cabinet, safe, or other structure which provides a double locked secured system.”
- Ordering: A DEA Form 222 or CSOS Form 222 will be required for all pharmacy orders for HCPs invoiced or delivered on or after October 6, 2014.
- Shortages: Due to the labeling changes, there is a possibility of a shortage of labeled C-III medications prior to October 6, 2014, or a shortage of labeled C-II medications on or after October 6, 2014.
- Returns: Any HCPs purchased in Schedule C-III packaging and returned on or after October 6, 2014, will require a DEA Form 222.
- Wholesalers: Wholesalers will now be required to increase storage security for HCPs and store these products in vaults rather than in less restrictive controlled substance cages.
- Manufacturer Quotas: On or after October 6, 2014, manufacturers will be required to obtain quotas to continue manufacturing HCPs, with limited exception.
At the September 10-11 Tennessee Board of Pharmacy meeting, the Board opined that it is the responsibility of each pharmacy to create policies for implementation of this law in their pharmacies.
Important Information Regarding TennCare: TennCare, in a notice provided to TPA, stated that the Bureau has decided not to allow refills for hydrocodone products on or after October 6, 2014. TennCare advises pharmacists to assist patients who have existing prescription refills in obtaining new prescriptions for hydrocodone combination products in order to avoid delay and inconvenience for patients.
Patient Education Resources: NCPA has developed and provided resources including a sample letter to patients that pharmacies can use to communicate to their patients about the upcoming changes regarding prescriptions for HCPs. NCPA has given permission for pharmacies to use or modify and use thesample letter provided.
- DEA Final Rule language
- Pharmacy Audit Assistance Service (PAAS) summary of the Final Rule
- National Community Pharmacists Association (NCPA) summary of the Final Rule for community pharmacists
- NCPA summary of the Final Rule for NCPA members
- TennCare Notice Regarding Hydrocodone Rescheduling
TPA thanks NCPA for the information they have provided.
TPA will continue to monitor this situation and will provide members with any updates as they become available.