Shipping certain pharmaceuticals is getting a bit easier now that the U.S. Department of Transportation’s (DOT) Pipeline and Hazardous Materials Safety Administration (PHMSA) has been issuing special permits for take-back drugs. We’ll review how PHMSA’s special permits work and take a look at DOT-SP 20255 for take-back drugs.
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What are special permits?
Special permits allow a company or individual to package or ship a hazardous material in a manner that varies from the regulations, provided an equivalent level of safety is maintained. The PHMSA may also grant variances from the hazardous materials regulations (HMR) if actions are taken in accordance with standards issued by competent international authorities, such as the International Maritime Dangerous Goods code or the International Civil Aviation Organization.
When a company is granted a special permit, it receives a special permit authorization letter along with the special permit document itself. A new special permit may not exceed 2 years. Subsequent renewal applications may be granted for up to 4 years.
Move toward codification
By incorporating special permits into the HMR, the PHMSA intends to eliminate the need for numerous requests to renew special permits and approvals and reduce paperwork burdens.
Under a plan developed in 2010, the PHMSA is in the process of reviewing all active special permits and identifying those that should be incorporated in the HMRs, while noting that not all special permits are appropriate for incorporation.
Why take-back drugs need a special permit
In September 2014, the Drug Enforcement Administration (DEA) issued a final rule that allows manufacturers, distributors, reverse distributors, narcotic treatment programs, hospitals and clinics with on-site pharmacies, and retail pharmacies to have drug mail-back programs and maintain on-site collection receptacles. PHMSA’s special permit (SP) 20255 allows qualifying shippers and carriers who have applied for the permit to comply with the DEA mail-back and collection regulations.
What is SP 20255?
SP 20255 is for the highway and rail shipments of liners that contain the materials collected under drug take-back programs authorized by the DEA. It applies to the transportation of controlled substances that are to be disposed of under DEA regulations found at 21 CFR 1317.30 to 21 CFR 1317.85. The list of controlled substances, which includes anabolic steroids and opiates, can be found at 21 CFR 1300.01. They are the drugs authorized by the DEA for take-back programs.
SP 20255 requirements
As noted, SP 20255 applies only to highway and rail shipments. In addition to meeting specific packaging requirements for the drugs, shippers and carriers who want to transport take-back drugs must:
- Apply to PHMSA for the special permit. Under SP 20255, they may ship or transport only the materials collected for disposal by those registered with the DEA for the take-back program or by government entities collecting used drugs through take-back events, mail-back programs, or collection receptacles located at the law enforcement’s building.
- Maintain a current copy of SP 20255 at each facility where the packages are offered for transportation.
- Train employees on the provisions of SP 20255 in addition to the other training required for hazmat employees. Note that the PHMSA has previously indicated that simply reading or describing the training requirements specific to the special permit is not sufficient in most cases to ensure understanding by the employee and could result in significant gaps in training.
- Follow the DOT requirements for immediately notifying the National Response Center of a hazardous material incident and for detailed hazardous materials reports.
Tune into tomorrow’s Advisor for the packaging requirements of SP 20255.