VCKVetComplianceKit

Sample

See a real section of the kit

This is one section of one of the four documents in the kit — Section 1 of the DEA Controlled Substance SOP, generated for a fictional practice. Your kit is customized to your practice and state, and runs to roughly 60 pages across four documents. Every regulatory line is cited; the sources for this section are listed at the end.

1. Registration and renewal

1.1 Who must be registered

Every person who dispenses controlled substances must obtain a DEA registration unless exempted 1. For this practice, that means the practice (or its owner-veterinarian(s), depending on how the registration is held) must hold a current DEA Certificate of Registration for the "dispensing" business activity before any controlled substance is ordered, stored, administered, or dispensed at 100 Sample Street, Austin, TX 78701 1 2.

Associate veterinarians who are agents or employees of another practitioner (other than a mid-level practitioner) registered to dispense controlled substances may, when acting in the normal course of business or employment, administer or dispense (other than by issuance of prescription) controlled substances under the registration of the employer or principal practitioner, if and to the extent the jurisdiction in which they practice authorizes or permits it 3; confirm the arrangement your practice uses with your state board and record it in Section 10. Practice policy: keep a photocopy or PDF of every active DEA certificate used at this location in the compliance binder.

1.2 Registration cycle, form, and fee

  • Practitioner ("dispensing") registrations are issued on DEA Form 224 and renewed on DEA Form 224a, with a 3-year registration period 2.
  • The application fee shown in the current federal fee table is $888 for the 3-year period (verify the current fee when you apply — fees change by rulemaking) 2.
  • An initial registration may run between 28 and 39 months so DEA can align you to a monthly expiration group; after the initial period, the registration expires 36 months from the initial expiration date 2.
  • Applications and renewals are accepted only online through the secure application portal on DEA's website (www.DEAdiversion.usdoj.gov) 2.

1.3 Renewal procedure

  1. DEA sends renewal notifications by email approximately 60 calendar days before expiration; the registrant is responsible for keeping a current email address in DEA's application portal 2. Practice policy: Dr. Alex Rivera verifies the portal email address at every biennial inventory.
  2. A registrant may apply for renewal not more than 60 days before the expiration date 2.
  3. Your kit's compliance calendar (Document 4) carries your computed renewal reminder: 60 days before the expiration date printed on your DEA Certificate of Registration.
  4. No one may continue dispensing activity on an expired registration — no person required to be registered may engage in the activity until the application is granted and a Certificate of Registration is issued 2. However, if a renewal application is filed at least 45 days before the expiration date and DEA has issued no order on it by that date, the existing registration is automatically extended and continues in effect until the date DEA issues its order 4. Practice policy: if a lapse ever appears likely, stop CS ordering immediately and call the local DEA Registration Specialist.

1.4 Locations, house calls, and mobile work

A separate registration is required for each principal place of business or professional practice at one general physical location where controlled substances are dispensed 5. Federal law makes a specific allowance for veterinarians: a registered veterinarian may transport and dispense controlled substances in the usual course of veterinary practice at a site other than the registered location without a separate registration, so long as the site is in a state where the veterinarian is licensed to practice and is not itself a principal place of business 5. House-call and ambulatory work from this practice operates under that allowance; all stock still lives at, and all records still return to, the registered location 6.

1.5 State controlled substance registration

Texas requires no separate state controlled-substance registration. Texas eliminated its state controlled substances registration effective September 1, 2016: the state-registration subsections of Health and Safety Code §481.061 were repealed by S.B. 195 (2015), and the section — now titled "Federal Registration Required" — provides that a person "registered with or exempt from registration with the Federal Drug Enforcement Administration" may handle controlled substances in Texas to the extent the DEA registration authorizes 7. Your DEA registration is the only controlled-substance registration this practice needs. The Texas Board of Veterinary Medical Examiners (TBVME) rule on point simply requires compliance "with all requirements of the federal Drug Enforcement Administration (DEA) regarding controlled substance registration" and with related state and federal law 8.

Two Texas additions to carry through this SOP:

  • Storage standard. TBVME requires all Schedule I–V stock to be "stored in a securely locked, substantially constructed cabinet or security cabinet" and bars access to CS storage areas "except those authorized agents required for efficient operations" 9 10. Apply this standard in the storage and security section. The rule text as archived also requires a written list of all persons with access to CS storage areas, with the dates individuals are added or removed 9 — keep the access list current (see the confirmation box below).
  • Inspections. TBVME conducts unannounced, risk-based inspections of a veterinarian's controlled-substance handling and may examine and copy drug records, invoices, inventory logs, and surgery logs 10. Keep this SOP and its logs inspection-ready at the practice.

Sources cited in this section

  1. DEA / 21 CFR — 21 CFR 1301.11(a) — Persons required to register. https://www.ecfr.gov/current/title-21/section-1301.11 (checked 2026-07-06)
  2. DEA / 21 CFR — 21 CFR 1301.13(a), (b), (d), (e)(1)(iv), (e)(2)-(3) — Application for registration; time for application; expiration date; application forms, fees. https://www.ecfr.gov/current/title-21/section-1301.13 (checked 2026-07-06)
  3. DEA / 21 CFR — 21 CFR 1301.22(b) — Exemption of agents and employees; affiliated practitioners. https://www.ecfr.gov/current/title-21/section-1301.22 (checked 2026-07-06)
  4. DEA / 21 CFR — 21 CFR 1301.36(i) — Suspension or revocation of registration; suspension of registration pending final order; extension of registration pending final order. https://www.ecfr.gov/current/title-21/section-1301.36 (checked 2026-07-06)
  5. DEA / 21 CFR — 21 CFR 1301.12(a), (c) — Separate registrations for separate locations. https://www.ecfr.gov/current/title-21/section-1301.12 (checked 2026-07-06)
  6. DEA / 21 CFR — 21 CFR 1304.21(a), (b), (d), (e) — General requirements for continuing records. https://www.ecfr.gov/current/title-21/section-1304.21 (checked 2026-07-06)
  7. Texas Legislature / Health & Safety Code — Tex. Health & Safety Code §481.061 — Federal Registration Required. https://statutes.capitol.texas.gov/Docs/HS/htm/HS.481.htm (checked 2026-07-06)
  8. Texas Board of Veterinary Medical Examiners / 22 TAC — 22 TAC §573.43 — Controlled Substances Registration. https://web.archive.org/web/20230609211143/https://texreg.sos.state.tx.us/public/readtac$ext.TacPage?sl=R&app=9&p_dir=&p_rloc=&p_tloc=&p_ploc=&pg=1&p_tac=&ti=22&pt=24&ch=573&rl=43 (checked 2026-07-06)
  9. Texas Board of Veterinary Medical Examiners / 22 TAC — 22 TAC §573.61 — Minimum Security for Controlled Substances. https://web.archive.org/web/20150908125339/http://texreg.sos.state.tx.us/public/readtac$ext.TacPage?sl=R&app=9&p_dir=&p_rloc=&p_tloc=&p_ploc=&pg=1&p_tac=&ti=22&pt=24&ch=573&rl=61 (checked 2026-07-06)
  10. Texas Board of Veterinary Medical Examiners — TBVME enforcement page; Tex. Occ. Code §801.164 — Compliance Inspections (risk-based controlled-substance inspections). https://veterinary.texas.gov/enforcement/compliance-inspections/ (checked 2026-07-06)