• High abuse potential
• Severe psychological or physical dependence profile
• No accepted medical use in the US

Rule: No permitted prescribing, dispensing, or administering

Exception: Research activities -- requires separate registration as researcher

• High abuse potential
• Severe psychological or physical dependence profile
• Has accepted medical use in the US

Narcotics

Morphine, codeine, hydrocodone, opium, cocaine, hydromorphone, methadone, meperidine, oxycodone, fentanyl

Stimulants

Amphetamine, methamphetamine, methylphenidate

Amobarbital, glutethimide, pentobarbital, secobarbital

• Abuse potential -- less than CII, more than CIV

Products containing less than 15 mg of hydrocodone per dosage unit (Vicodin, Lorcet, Tussionex)

Products containing not more than 90 mg of codeine per dosage unit (codeine with APAP, ASA, or IBU)

Anabolic steroids, benzphetamine, phendimetrazine, and any compound, mixture, preparation, or suppository dosage form containing amobarbital, secobarbital, pentobarbital, dronabinol, or ketamine

• Abuse potential, but much fewer physical dependency concerns -- less than CIII, more than CV

Narcotics: propoxyphene, butorphanol, pentazocine

Benzodiazepine-type substances: alprazolam, clonazepam, clorazepate, diazepam, flurazepam, halazepam, lorazepam, midazolam, orazepam, prazepam, temazepam, triazolam, quazepam

Other: barbital, phenobarbital, chloral hydrate, ethchlorvynol, chlordiazepoxide, ethinamate, meprobamate, paraldehyde, methohexital, phentermine, diethylpropion, pemoline, mazindol, sibutramine

• Less abuse potential than CIV
• Consists primarily of preparations containing limited quantities of certain narcotic and stimulant drugs
• Generally for antitussive, antidiarrheal, and analgesic  purposes

Cough preparations containing not more than 200 mg of codeine per 100 ml (Robitussin AC, Phenergan with Codeine)

Application for New Registration

• Pharmacist must fill this form in order to dispense controlled substances
• Registration must be renewed every 3 years

• Registration with the DEA must be every 3 years
• Registrants receive a renewal application from the DEA ~ 45 days before registration expiration
• If the renewal form is not received within 30 days before the expiration date of the current expiration, the pharmacy should contact the DEA registration unit

• Only CI and CII are ordered with this form
• When there is a change of address, the DEA will issue a new certificate of registration and, if requested, new Schedule II order forms

• Renewal Application for Registration will only be sent to the registered address on file with the DEA

The US Attorney General may suspend or revoke a DEA registration upon a finding that the registrant has:

1. Materially falsified any portion of the DEA application
2. Been convicted of a felony relating to a controlled substance
3. Had its state license or registration suspended, revoked, or denied
4. Committed an act which would render his/her registration inconsistent with the public interest
5. Been excluded from participation in a Medicaid or Medicare program

• Any registrant who discontinues his/her business or transfers it to another person must notify the local DEA office in writing before terminating the pharmacy's registration
• Send back the DEA Certificate of Registration and any unused Official Order Forms (DEA Form-222)
• The registrant should write or stamp the word "VOID" across the face of EACH Official Order Form before returning them to the DEA
• The notice to DEA should indicate where the controlled substance inventories and records will be kept and how the controlled substances were transferred or destroyed (with these records kept for 2 years)

If transferring a pharmacy business to another registrant, notify the nearest DEA at least 14 days before the date of the transfer and provide the following information:

1. Name, address, registration number of the registrant discontinuing/acquiring the business
2. Whether the business activities will be continued at the current registration location or moved to another location.  If the latter, provide the address of the new location and;
3. The date on which the controlled substances will be transferred to the registrant acquiring the pharmacy

• On the day the controlled substances are transferred, a complete inventory must be taken documenting the drug name, dosage form, strength, quantity, and date transferred
• A copy of the inventory must be included in the records of both the person transferring the business and the person acquiring the business
• DEA Form-222 (Official Order Form) must be prepared to document the transfer of Schedule II controlled substances
• This inventory will serve as the final inventory for the registrant going out of business and as the initial inventory for the registrant acquiring the controlled substances

• Once each calendar year, retail pharmacies may request authorization to destroy damaged, outdated, or otherwise unwanted controlled substances
• Must complete DEA Form-41 (Registrants Inventory of Drugs Surrendered)
• Must prepare a letter requesting permission to destroy the controlled substances, proposing a date and method of destruction, and listing the names of at least 2 people to witness the destruction
• Witnesses should be either a licensed pharmacist, nurse, physician, mid-level practitioner, or from law enforcement
• Signed copies of the DEA Form-41 must be forwarded to the DEA

1. Notify DEA and local police
2. Complete DEA Form-106 (if warranted)
3. If investigation finds no theft or loss (no DEA Form-106)
4. It is the registrant's responsibility for identifying "significant loss"

1. Schedule of missing items
2. Abuse potential of missing items
3. Abuse potential in the area 
4. Quantity missing
5. First time?
6. Was it reported to local law enforcement authorities?
7. If there is question as to whether a loss is significant, a registrant should err on the side of caution and report it to the DEA

• Shipment to a "reverse distributor" or by a DEA approved process
• When this disposal occurs, it must be reported to DEA on a DEA Form-41

Provides for Federal Investigation of pharmaceutical thefts and robberies if any of these conditions exist:

1. Replacement cost of the controlled substances taken is $500 or more
2. A registrant or other person is killed or suffers "signifcant" bodily injury during the commission of the robbery or theft of a controlled substance
3. Interstate or foreign commerce is involved in planning or executing the crime

Records of controlled substances must be:

1. Maintained for 2 years
2. Records and inventories of CII must be maintained separately from all other records of the registrant
3. CIII, CIV, and CV must be maintained either separately from all other records in such a form that the information required is readily retrievable from the ordinary business records

• Records maintained by automatic data processing systems or other electronic or mechanized means such that they can be separated out from all other records in a reasonable amount of time (< 24 hrs)
• Records with items which are asterisked, red-lined, highlighted or in some manner visually distinct from other items appearing on the records

Three Separate Files

1. a file for CII drugs dispensed
2. a file for CIII-CV drugs dispensed
3. a file for prescription orders for all noncontrolled drugs dispensed

Two Separate Files

• a file for all CII drugs dispensed
• a file for all other drugs dispensed

If this method is used, a prescription for CIII-CV drugs must be made readily retrievable by use of a red "C" stamp not less than one inch high

Two Separate Files

• a file for all CII-CV drugs dispensed
• a file for all other drugs dispensed

If this method is used, a prescription for CIII-CV drugs must be made readily retrievable by use of a red "C" stamp not less than one inch high

• Maintained at registered location in a readily retrievable manner
• Inventory of CII must be kept separate from all other controlled substances
• No requirement to submit a copy to the DEA
• Following the initial inventory, the registrant is required to take a biennial inventory (every 2 years)

False

Must be exact

True

Exception: opened containers > 1000 units -- must be exact

• Requires a written prescription which must be signed by the practitioner
• There is no time limit when a CII prescription must be filled after being signed by the physician
• Federal regulations place no quantity limits on Rxs
• Oral Rx is permitted ONLY in an emergency situation
• Refilling a CII is prohibited
• A prescriber may fax the CII Rx; must eventually get the original

• Written prescription signed by a practitioner
• Fax of that Rx transmitted by the practitioner or his/her agent
• Oral Rx given by the practitioner or his/her agent, which the pharmacist must promptly reduce to writing
• e-Rx in conformance with federal and state e-prescribing laws
• Pharmacists may partially dispense a prescription
• All refills to be dispensed within a 6 month period

Under a bona fide emergency:

• From a valid practitioner
• Immediately reduced to writing by RPh
• Covers emergency period ONLY
• Receive a written, signed Rx within 7 days
• Written on face: "Emergency Dispensing"

• May be partially dispensed if unable to supply the full quantity
• Remaining portion may be dispensed within 72 hrs of the first partial dispensing --> HOWEVER, if the remaining portion is not or cannot be dispensed within the 72 hr period, the pharmacist must notify the prescribing practitioner
• No quantity may be supplied beyond the 72 hr, except a valid, new prescription

• CII- Form 222 required
• Total number of dosage units of controlled substances distributed by a pharmacy may not exceed 5% of all controlled substances dispensed by the pharmacy during a calendar year
• If controlled substances is in excess of 5%, the pharmacy must register as a distributor