DEA & Compounding

Question 1

How to do DEA registration

Answer 1

• must include physical location/name
• DVMS may function as agents of the registrant
• Agents may dispense/administer
• Only DVMs w/ valid DEA # may prescribe
• Power of attorney may be granted for ordering inventory

Question 2

Storage of controlled drugs and forms

Answer 2

• locked cabinet for CII-CV
  
  • Carfentanil, etorphine, diprenorphine stored in a CV security container
• Schedule II order forms locked up as well
• Keep records of ordering and administration separate

Question 3

What form is used to order controlled (CII) substances?

Answer 3

DEA222

Question 4

Controlled Drug Schedule is defined by:

Answer 4

1. potential for abuse
2. established medical use or lack thereof
3. potential for psychological or physical dependence

Question 5

CII

Answer 5

high abuse potential, accepted medical use, high potential for psychological or physical dependence w/ abuse (ex. Opioids, hydrocodone, methadone, fentanyl)

Question 6

CIII/IIIN

Answer 6

• less potential for abuse than drugs in CI/II, accepted medical use, potential for moderate to low physical dependence or high psychological dependence w/ abuse (III narcotics: Buprenorphine)
• IIIN (non-narcotics): ketamine, pentobarbital/phenytoin (Beuthanasia)

Question 7

CIV

Answer 7

low potential for abuse relative to CIII, accepted medical use, abuse of drug may lead to limited physical dependence or psychological dependence relative to CIII (Ex. Benzodiazepines, Barbiturates, tramadol, alprazolam, diazepam, midazolam)

Question 8

CV

Answer 8

low potential for abuse relative to CIV, accepted medical use, abuse of the drug may lead to limited physical dependence or psychological dependence relative to CIV (Ex. Diphenoxylate/Atropine)

Question 9

Inventory

Answer 9

Take initial and biennially; don’t store records (CII) with other inventory records

• no requirement to turn in form to DEA

Question 10

Expired drugs

Answer 10

• must be quarantined/kept secure
• can either be returned to manufacturer, DEA form 41: registrants inventory of drugs surrendered, or reverse distribution
• MUST maintain disposal records

Question 11

Loss or theft

Answer 11

DEA Form 106: MUST be reported within 1 business day of discovery

Question 12

Prescriptions

Answer 12

• CII: no refills - written Rx required
• CII-V: 5 refills in 6 months; may be called in by DEA registratnt/their agent, oral Rx for CIII may not be filled for >30 days

Question 13

Misbranding

Answer 13

labeling, warnings/precautions, directions, sell by expiry

Question 14

Compounding

Answer 14

Vets are legal prescribers, dispensers, and compounders in Florida

• should be dispensed per valid VCPR:
  
  • intolerable dosage form commercially available
  • allergies
  • inappropriate concentration by volume commercially available
• May NOT be made: to reduce cost or when copies are available

Question 15

CI

Answer 15

no currently accepted medical use, lack of accepted safety for use, high potential for abuse (ex: heroin, LSD, marijuana, peyote, Ecstasy)

Question 16

How long do you keep records for?

Answer 16

DEA: 2 years

Florida practice: 4 yrs (shelter/pharmacy), 3 yrs (veterinary)

Statute of limitations: 5 yrs

Question 17

Adulterated

Answer 17

strength/quality, container/closure, manufacturer GMP

Question 18

Packaging

Answer 18

United States Poison Prevention Packaging Act of 1970

Question 19

Counterproof prescription pads are/are not required in FL for vets?

Answer 19

are not

Question 20

What are NPI numbers?

Answer 20

National Provider Identifier: 10 digit ID # required by HIPAA and assigned through National Plan and Provider Enumeration System - for Medicare/Medicaid

• not legal for vets to hold but can be obtained

Question 21

Certain products that may not be compounded

Answer 21

FARAD: food animal restrictions

• FDA alert items: trilostane, phenylbutazone (horses), proin chewables