Pharmacist's Manual

Closed System of Distribution

All handlers of controlled substances (besides end-users/patients) including manufacturers, distributors, physicians/prescribers, and pharmacies MUST be registered with the DEA and maintain strict accounting for all transactions

Schedule 1 Controlled Substances

HIGH potential for abuse, no accepted medical use

Example: heroin, LSD, MDMA, marijuana

Schedule 2 Controlled Substances

HIGH potential for abuse which may lead to severe psychological or physical dependence, accepted medical use with strict restrictions

Example: narcotics, stimulants, amobarbital

Schedule 3 Controlled Substances

Potential abuse less than schedule 1 or 2, and may lead to high psychological dependence or moderate to low physical dependence

Example: certain morphine products, buprenorphine, ketamine, testosterone products

Schedule 4 Controlled Substances

Have low potential for abuse compared to other higher controlled substances, abuse may lead to limited physical or psychological dependence

Example: tramadol, benzodiazepines

Schedule 5 Controlled Substances

Have low potential for abuse compared to other higher controlled substances, abuse may lead to limited physical or psychological dependence

Examples: cough preparations containing no more than 200mg of codeine per 100mL

Schedule Listed Chemical Products

products that contain ephedrine, pseudoephedrine, or phenylpropanolamine and marketed as over the counter

DEA Form 223

Certificate of Registration: maintained at registered location and available for inspection

DEA Form 224

Registration of new pharmacy

DEA Form 224a

DEA renewal registration form - renewed online, no earlier than 60 days prior to expiration date

Renewal and Reinstatement of DEA Registration

DEA allows reinstatement of an expired registration for one calendar month

Federal law prohibits handling of controlled substances for any period of time under an expired registration

DEA Form 224b

chain pharmacy renewal - if corporation owns or operates a chain of pharmacies, submit in lieu of separate renewal applications for each location

DEA requests corporations with 50 or more retail registrations enroll in the Chain Renewal program

Registration Requirements Change of Business Address

BEFORE moving to a new physical location, pharmacy should request a modification to their current registration

If modification is approved, DEA will issue an updated Certificate of Registration, and if requested, new Schedule II order forms

Registrant is to maintain the new certificate with the old certificate until the expiration date

Registration Requirements Termination of Registration

If a pharmacy discontinues business activities or stops dispensing controlled substances, it must return its DEA Registration certificate AND any unused DEA Form 222 to the local DEA specialist office

DEA may ask for location where inventories, prescriptions, and other required controlled substance records will be stored for the two-year record retention period

Registration Requirements Transfer of Business

MUST submit in person or by certified mail to the Special Agent in Charge at least 14 days in advance of proposed transfer

On the day of the controlled substances are transferred, a complete inventory must be taken, copy of the inventory must be included in the records of each registrant

Registration Requirements Chemical Registrations

DEA registration is not required for regulated sellers of scheduled listed chemical products

Regulated seller must self-certify with DEA under the Combat Methamphetamine Epidemic Act

Ordering Controlled Substances

Use DEA Form 222 and may use electronic equivalent

REQUIRED for any distribution or transfer of Schedule I or II

Purchaser must make a copy of the original form for their records and send to the original order form to the supplier

Each form must be signed and dated by a person authorized to sign a registration application or a person granted power of attorney

Electronic copies do NOT need to be stored on a different server from the registrant’s other records

Requesting DEA Forms 222

Order forms issued in mailing envelopes with quantities sent to registrants based on their business activity

May be ordered via phone or online with the DEA

Order forms are sent in numeric sequence and are issued with the name, address, and registration number of the registrant

Power of Attorney to Sign DEA Forms 222

Any registrant may authorize one or more individuals, whether or not they are located at the registered location, to obtain and execute DEA Forms 222

Power of Attorney must be signed by the registrant, a partner of the registrant, or an officer of the registrant corporation, the person to whom the power of attorney is being granted, and two witnesses

Power of Attorney can be revoked at any time!

Lost or Stolen DEA Forms

purchaser must execute a new DEA form and attach a statement containing the order form number and date of the lost form and stating the original items were not received

A copy of the second form must be kept with the copy of the first form along with a copy of the above mentioned statement

Any lost or stolen forms must be reported immediately to the local DEA Diversion Field Office and provide the Order Form numbers or approximate date of issuance that are lost or stolen

Controlled Substance Ordering System (CSOS)

Any registrant permitted to order Schedule II may do so electronically using CSOS

completely optional

ONLY electronically means of ordering Schedule II medications

Electronic orders are to be signed using a digital signature which is password protected

Ordering all other Controlled Substances

Registrant must keep a receipt/invoice or packing slip on which is records the date the drugs are received and confirm that the order is accurate

Receipts must be maintained either separately from all other records or readily retrievable

Inventory

complete and accurate list of all controlled substances in the possession of the registrant on the date the inventory is taken

CII Inventory

actual physical count required

All other Controlled Substances Inventory

If open bottle contains <1,000 tablets/capsules, may make the estimated count

If container holds more than 1,000 tablets/capsules, must make exact count

Valid Prescription Requirements

patient full name and address

Practitioner’s full name, address, and DEA registration number

Drug name, strength, dosage form

Quantity prescribed

Directions for use

Number of refills authorized (if any)

Who must be registered with the DEA?

All individuals, manufacturers, distributors, labs, exporters, narcotic treatment programs or dispensing locations (pharmacies) which are authorized to possess controlled substances

Who does NOT need its own DEA registration?

Warehouses, practitioner’s office, common carriers, sales offices

Scheduling of Compounded Controlled Substances

A pharmacy may compound narcotic controlled substance prescriptions pursuant to a prescription

DEA limits to not more than 20% concentration

Must be compounded with one or more nonnarcotic therapeutic ingredients

ARCOS Registrant

Automated Reports and Consolidated Ordering System: A manufacturer or distributor required to report controlled substance inventories and transactions to DEA

Practitioner Self-Prescribing

Prescription for a controlled substance is valid only if it is issued for a legitimate medical purpose by a practitioner acting in the usual course of sound professional practice

Faxing of Schedule II Prescriptions

Allowable for home infusion pharmacies, resident of a LTCF, hospice patient (can be a patient at home or in a hospice facility)

Labeling Schedule II Prescriptions

Date of filling, pharmacy name and address, Rx number, name of patient, name of prescriber, directions for use, “Caution: Federal” auxiliary label, other cautionary statements contained in prescription of required by law

Controlled substances that must be inventoried include those:

On inventory shelves or in locked cabinet

Returned by a customer

Ordered by customer by not yet sold

Stored in warehouse on behalf of registrant

In possession of employees of registrant and intended for distribution as complimentary samples

DEA Verification Calculation

Add 1st, 3rd, and 5th

Add 2nd, 4th, 6th and multiply sum by two

Add results of calculations together

DEA is valid if: last digit in the sum from above is the same as the last digit of the DEA number

DEA Form 106

Formally document the circumstances and quantities lost once this information has been determined

Send copy of 106 to DEA and retain a copy

CMEA pseudoephedrine maxes

3.6 grams/day max

9 grams/30 days max