Make Sure Your Compounding Pharmacy is in Compliance: Louisiana Board of Pharmacy Correctly Announces that the federal rule placing tramadol products as Schedule IV controlled substances supersedes all state laws that placed tramadol as a drug of concern etc. and not a controlled substance.

DEA Federal Register Notice [FR 79:127] – effective August 18, 2014

This federal rule places all tramadol (Ultram® et al) products in Schedule IV of the federal list of controlled substances. Prior to the effective date, tramadol was classified federally as a prescription drug product but not a controlled substance, and in Louisiana was classified as a prescription drug product as well as a ‘drug of concern’ but not a controlled substance. This federal rule will supersede the state classification; all of our licensees are obligated to adhere to the recordkeeping, physical security, and all other requirements applicable to controlled substances listed in Schedule IV. 

• For those distributors, practitioners and pharmacies in possession of tramadol products on August 18, a complete inventory of such products shall be conducted to establish an opening inventory level. The inventory record shall be stored with other controlled substance inventory records. Effective August 18, your continued acquisition, possession, distribution, prescribing and/or dispensing of tramadol products shall require a current Louisiana CDS license and a current DEA registration, both with affirmative indicators for Schedule IV.
  
• Distributors, practitioners and/or pharmacies not in possession of both the state and federal controlled substance credentials noted above and which are holding tramadol products shall dispose of such products, by any lawful method appropriate for prescription drug products, prior to August 18.
  
• Effective August 18, the distribution of tramadol products shall require the purchaser to demonstrate possession of a current Louisiana CDS license and a current DEA registration, both with affirmative indicators for Schedule IV.
  
• Effective August 18, tramadol products distributed to purchasers shall bear a label containing all information required for controlled substances listed in Schedule IV. Practitioners and pharmacies holding tramadol products bearing a ‘pre-scheduling’ label may continue to use such stock containers for dispensing and medication administration purposes, but they may not further distribute such products with a ‘pre-scheduling’ label.
  
• Prescriptions for tramadol products issued prior to August 18 shall expire six months after the date of issue. Originally authorized refills remaining on such prescriptions shall comply with the limitations applicable to Schedule IV products: the first five refills may be dispensed within the six months following the date of issue. In the event more than five refills were originally authorized, or in the event there are any refills remaining six months after the date of issue, all such refills shall be automatically voided.
  
• Prescriptions for tramadol products issued on or after August 18 shall comply with the usual limitations applicable to Schedule IV products – may be issued in oral, written or electronic form, expires six months after the date of issue, and a maximum of five refills that were originally authorized provided that no refills are dispensed more than six months after the prescription was issued. Multiple partial fills are permitted provided the total quantity dispensed does not exceed the total quantity authorized [original + originally authorized refills] and none are dispensed more than six months after the prescription was issued.
  
• We encourage prescribers using electronic drug databases to check with their vendors to ensure the correct controlled substance coding of tramadol drug products in the master drug file of their databases and information systems.
  
• Pharmacies and other dispensers of tramadol prescriptions have been required to report their eligible prescription transactions to the Louisiana Prescription Monitoring Program (PMP) due to its status as a ‘drug of concern.’ With the new federal rule, it will no longer be a ‘drug of concern’ but a controlled substance listed in Schedule IV. All dispensers of tramadol prescriptions will still be required to report their eligible prescriptions to the Louisiana PMP. We encourage you to check with your pharmacy information system vendor to ensure the correct controlled substance coding of tramadol drug products in the master drug file of your information system.
  Act 865 (SB 496) of 2014 Legislature – effective August 1, 2014
  This law imposes a new requirement on prescribers of certain controlled substances, places an expiration date on prescriptions for drugs listed in Schedule II, and places quantity limits on the dispensing of prescriptions for certain controlled substances. 
  

memo from Louisiana Board of Pharmacy regarding Tramadol and other drugs found here