Federal Guidelines for Dispensing Buprenorphine Tablets in the Office

When buprenorphine was first approved by the FDA in October 2003, few pharmacies consistently kept the medication in stock and thus many physicians kept a supply of tablets on hand and dispensed them from their office. In-office buprenorphine dispensing is still a legal practice under DATA 2000.

However, physicians who wish to dispense buprenorphine from their office must adhere to strict federal recordkeeping guidelines.

The following records must be maintained for 2 years:

  • Inventories, including amounts of buprenorphine received and amounts dispensed
  • Reports of theft or loss
  • Destruction of controlled drugs
  • Records of dispensing

Additionally, the buprenorphine tablets must be stored in a secure, locked cabinet. Note that physicians who have their patients get their prescription filled at a pharmacy and return to the office for induction are NOT subject to the same recordkeeping guidelines as physicians who store and dispense the tablets in-office.



Related Resources: 
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This page links to the full text, summary, and physician waiver requirements under DATA 2000.
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Substance Abuse and Mental Health Services Administration (SAMHSA)
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This log can be used to keep track of office inventories of buprenorphine medication.
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California Society of Addiction Medicine (CSAM)
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