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January 2015, Vol 3, No 1 - From the Trenches
Thomas McAbee

We appreciate the editorial published in Inside Patient Care: Pharmacy & Clinics pertaining to the role of retail pharmacy in controlled substance take-back programs.1 However, we believe that the assertion that retail pharmacies will have to register as reverse distributors in order to accept controlled substances is incorrect.

If a retail pharmacy maintains a collection receptacle where ultimate users can deposit their unwanted controlled medications, the retail pharmacy is not a reverse distributor, but rather an authorized collector.2 The distinction is important.

A retail pharmacy seeking to be an authorized collector needs to modify its Drug Enforcement Administration (DEA) registration. Once the registration is modified, the DEA Certificate of Registration (DEA Form 223) can be printed out and will indicate the words “retail pharmacy-collector” in the “business activity” section (see 1317.30 and 1317.40).2

A retail pharmacy that becomes an authorized collector is permitted to maintain a collection receptacle for controlled and noncontrolled medications from ultimate users, but not from other DEA registrants (see 1317.40[c][2]).

A reverse distributor is a DEA registrant that is authorized to accept controlled substances from other DEA registrants. Therein lies the distinction: collected from ultimate users versus other DEA registrants (see 1317.15[a], which states “or otherwise authorized pursuant to this chapter”).2 A pharmacy is “otherwise authorized pursuant to” 1317.30, and therefore, a pharmacy is not required to register as a reverse distributor.

The distinction between an authorized collector and a reverse distributor is emphatically pronounced in their respective fees. A retail pharmacy now needs to pay a 3-year fee of $731 to be an authorized collector, whereas the fee to be a reverse distributor is $1523 annually. The Secure and Responsible Drug Disposal Act of 2010 and the DEA’s regulations prohibit the DEA from charging increased fees to register as an authorized collector.3 Requiring a retail pharmacy to register as a reverse distributor would violate the Secure and Responsible Drug Disposal Act of 2010.

Because the regulations are new and somewhat “thick,” we are all going through a learning curve that will take some time to overcome. Southrifty Drug was the first retail pharmacy in the United States to register as an authorized collector on October 9, 2014.

(See "Reply to the Letter to the Editor: Authorized Collector versus Reverse Distributor.")




References

  1. Dietz D. Pharmacy role in controlled substance take-back programs. Inside Pharmacy. 2014;2(5):8-9.
  2. US Department of Justice, Drug Enforcement Admini­stration. Rules 2012: Disposal of Controlled Substances. www.deadiversion.usdoj.gov/fed_regs/rules/2012/fr1221_8.htm. Accessed January 7, 2015.
  3. Drug Enforcement Administration. Secure and Responsible Drug Disposal Act of 2010. www.deadiversion.usdoj.gov/drug_disposal/non_registrant/s_3397.pdf. Accessed January 7, 2015.

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