BOP Program Statement 6360.03 § 9

a. Applicability of Federal Law. Controlled substances are drugs and drug products under

jurisdiction of the Controlled Substances Act of 1970 and are divided into five schedules (I, II,

III, IV, and V). Nothing in this section will be construed as authorizing or permitting any person

to engage in any act that is not authorized or permitted under existing federal laws, or that does

not meet regulations published in the most recent edition of 21 CFR Chapter II.

b. DEA Registration. The institution is the DEA registrant. The Institution Chief Pharmacist who

manages the registration on behalf of the institution is the Officer of the Registrant. At institutions

without a Bureau pharmacist, the following staff are responsible for fulfilling the role of the

Officer of the Registrant in this order of precedence: acting Chief Pharmacist (if applicable),

HSA, Assistant Health Services Administrator (AHSA), CD, Associate Warden (AW), and the

Warden. If the Institution Chief Pharmacist is vacant, the alternative Officer of the Registrant

will fulfill the functions listed throughout the remainder of this section.

The Officer of the Registrant may provide Power of Attorney (POA) for persons other than the

person who signed the current DEA registration to be able to manage the DEA registration and/or

order Schedule II controlled substances (i.e., obtaining and signing the DEA Form 222, U.S.

Official Order Forms – Schedules I & II). POA forms are kept with other controlled substance

records. POAs are void upon departure of the Officer of the Registrant. Refer to 21 CFR 1305.5

for further details and POA example.

The contact information for DEA registration and renewal is available at the DEA Diversion

Control Division portal. There is no cost for new or renewed registrations to the federal

government. The Bureau Chief Pharmacist contact information is entered as the fee exempting

official in the appropriate section. These applications are completed on-line.

 To obtain an initial DEA registration number under the Controlled Substances Act, the

Institution Chief Pharmacist completes a DEA Form 224, Application for Registration

Under the Controlled Substances Act. For legal purposes, it is very important Bureau

institutions are registered as “hospital/clinic” only.

 To renew a DEA registration, the Institution Chief Pharmacist completes a DEA Form

224a, Renewal Application for Registration Under the Controlled Substances Act or DEA

Form 363a, Renewal Application for Registration Under the Narcotic Addict Treatment

Act of 1974.

The institution DEA registration number is used only for official business and providers may not

use the institution DEA registration, provided under federal fee-exemption, outside of the

Bureau. Fee exemption is not authorized for personally held DEA numbers regardless of whether

they are being newly acquired or renewed.

Each institution will only have one registration number for controlled substances. One additional

DEA registration for Narcotic Treatment Program (NTP) may be authorized per institution for

Opioid Treatment Programs (OTP) under the guidance of the Bureau Chief Pharmacist. Each

Federal Correctional Complex in which all institutions are contiguously located on federal

property maintains only one DEA registration number for the complex. If the Complex’s

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institutions are not located on contiguous federal property, the Bureau Chief Pharmacist should

be contacted for guidance.

 Change of Officer of the Registrant. When an Officer of the Registrant (i.e., Institution

Chief Pharmacist) permanently departs from an institution, they should ensure the Officer

of the Registrant is updated to a new Officer of the Registrant, or that a POA for Officer of

the Registrant is on file with the DEA. Prior to departure, the off-going registrant and new

registrant or the newly designated POA will complete an inventory of:

 Main stock, sub-stock, and destruction controlled substances

 Controlled substance records

When a permanently assigned Officer of the Registrant arrives at an institution, the Officer

of the Registrant will be updated with the DEA, and a similar inventory will be completed

as soon as practical.

c. Security. The DEA, per 21 CFR Part 1301.71, requires safeguarding and accounting for all

controlled substances.

 The Institution Chief Pharmacist is the responsible authority for all controlled substances.

 The main stock of controlled substances is kept locked and stored in a vault or safe that

meets all DEA requirements. Only the Institution Chief Pharmacist and/or designee(s) has

the combination or keys.

 The HSA will ensure a duplicate set of keys or combinations of all vaults and safes in

Health Services are sealed in separate envelopes, plainly marked with contents, and

filed in the Warden’s or security officer’s vault or safe.

 The DEA registrant or designee must be present for any inventories, inspections,

searches or shakedowns of the storeroom, vaults, or safes.

 The Institution Chief Pharmacist will ensure all combinations or locks to main stock

vaults or safes storing controlled substances are changed:

 At transfer, reassignment, or termination of applicable Health Services

administrative or pharmacy personnel.

 When unusual circumstances dictate increased internal control measures.

 Controlled substances that are damaged, expired, or retrieved from inmates through R&D

will be segregated in the safe from other controlled substances and maintained on a

separate destruction inventory.

 Institutions with OTP certification providing methadone for opioid use disorder (OUD)

treatment may store bulk methadone in either a separate safe, distinct from that used to

store other controlled substances, or stored in the same vault, provided it is clearly

segregated from other controlled substances.

 Sub-stock controlled substances must be stored in a stationary, approved steel cabinet

with two separately key-locked steel doors, a safe with a keyed padlock, or AMDC.

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 When a controlled substance requires refrigeration, the medication must be secured in a

locked refrigerator restricted to only controlled substances or in a locked drawer within

the refrigerator if shared with non-controlled substances.

d. Purchasing and Receiving. Purchase orders for controlled substances will be prepared by a

designated staff member. The Institution Chief Pharmacist will establish a proper system of

security for their receipt. Controlled substances will be purchased in single-dose packaging when

available.

e. Records. All inventories and listings in the controlled substance records will be exact using

tablets, capsules, vials, etc., not in units of bottles or other bulk measurements. Any record

keeping error will be corrected by the person who made the error by drawing one line through

the error, writing an explanation directly below, and initialing. Errors may not be "blacked out.”

Consistent with 21 CFR 1304.4, the Institution Chief Pharmacist will maintain all records

pertaining to purchase, administration, inventory, and audits for at least two years prior to the

most recent federal biennial inventory. These records will be kept in a vault, safe, or readily

retrievable electronic format. No other items may be stored with controlled substances or their

records.

 Main stock Records. The pharmacist will maintain adequate main stock inventory

records via the current electronic pharmacy system for each controlled substance.

Headings will indicate:

 Sub-stock unit

 Date

 Record number/Purchase Order number

 Quantity received

 Quantity issued to sub-stock or dispensing

 Balance on hand

 Sub-stock Records. Controlled substances in sub-stock locations are to be used for

administration only (e.g., on medical/nursing units or DOT).

Sub-stock will have records maintained for proof of use for each controlled substance on

hand. The completed proof of use sheet will be returned to the pharmacy and kept with

controlled substance records. The use of an AMDC negates the need for proof of use

sheets for controlled substances.

Each proof of use sheet will contain:

 Name and strength of drug

 Date issued

 Amount issued

 Pharmacy control number

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 Department location (if applicable)

 Date and amount returned

 Date and time of administration

 Name and number of inmate

 Dosage administered

 Corresponding medication order number

 Signature of person administering

 Balance on hand

f. Sub-stock Inventories.

 For institutions using AMDCs, a complete sub-stock controlled substance inventory

must be completed through the AMDC at least once every quarter. For institutions with

higher usage rates, more frequent inventories are recommended.

 For institutions not using AMDCs, at the beginning of each shift, a staff member will

conduct a complete sub-stock inventory. This staff member will sign the “sub-stock

inventory certification sheet” for each shift.

 Access to the controlled substances sub-stock is limited to the staff member who is

responsible for the shift inventory of sub-stock.

 The staff member completing the sub-stock inventory certification sheet will return it

to the pharmacy. The pharmacist will review and retain the forms for two years prior

to the last federally mandated biennial inventory.

 The change of shift record will include:

 Date and time of the count

 Signature of off-going and oncoming staff

 Exact quantity of all controlled substances on hand in that sub-stock at that time

The only exceptions to inventory requirements for both of the above instances are properly sealed

emergency carts or kits.

g. Discrepancies. Discrepancies may occur for a variety of reasons, and it is important to

distinguish between human error and potential misconduct. If the cause of the discrepancy is

easily determined, staff will resolve the discrepancy immediately.

 The staff member discovering the discrepancy will notify the Institution Chief Pharmacist

and HSA per procedures outlined in the institution supplement.

 For institutions using an AMDC, an institution pharmacist will review discrepancy reports

daily. At institutions without a pharmacist, the HSA will perform this task.

 The institution supplement will include processes for monitoring and addressing

unresolved discrepancies.

h. Biennial Inventory. The Controlled Substances Act requires each registrant to make a

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complete and accurate record of all controlled substance stock on hand in all main stock and sub-stock locations every two years. The Institution Chief Pharmacist will complete the biennial

inventory on the date mandated by federal law. The Institution Chief Pharmacist will maintain

the inventory with the controlled substances records. The inventory records must include:

 The registrant’s name, address, and DEA registration number

 The date and time the inventory is taken (opening or close of business)

 Signature of the person or persons responsible for taking the inventory

 The name of each controlled substance

 The dosage form and unit strength of each controlled substance

 The number of units in each container of each controlled substance

 The number of each container of each controlled substance

 Separate Schedule II controlled substances from all others

i. Additional Auditing Requirements.

 Controlled Substances Inventory Team. The Controlled Substances Inventory Team

will consist of the HSA or designee, and at least one other supervisor.

 The Institution Chief Pharmacist will be a technical advisor and will be present during

the inventory but may not be a team member.

 The team will conduct a quarterly count of all main stock controlled substances

including controlled substances marked for destruction.

 Each team member will then sign the BP-A0825, Quarterly Narcotics Audit Team

Certificate form to be filed with the controlled substance records.

 A copy of this form should be sent to the Bureau Regional Chief Pharmacist.

 This count may be done at any time within the time frame of the quarter.

 Quarterly Report by Date Range. At the end of each quarter, the Institution Chief

Pharmacist will complete an Inventory Report by Date Range as produced by the

pharmacy software for controlled substances to include both main stock and destruction.

An electronic copy will be submitted to the Bureau Regional Chief Pharmacist within 30

days of the end of the quarter. Each quarterly report will reflect the usage pertaining to

the following dates (variance from these dates will not be allowed):

 1st Quarter = October 1 to December 31.

 2nd Quarter = January 1 to March 31.

 3rd Quarter = April 1 to June 30.

 4th Quarter = July 1 to September 30.

j. Theft or Loss. Any incident of theft or loss must be documented by the individual

discovering it. The Institution Chief Pharmacist will in turn send a memorandum to the HSA,

with a copy to the Warden. The Institution Chief Pharmacist, upon consultation with the Warden

will notify the DEA of significant loss, as defined by the DEA, of controlled substances via DEA

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Form 106, Report of Theft or Loss of Controlled Substances. The Institution Chief Pharmacist

will maintain a copy of this submission with the controlled substance records.

k. Disposal. The Institution Chief Pharmacist or designee will dispose of controlled substances

from the main stock inventory, when necessary, in the manner prescribed by the DEA in 21 CFR

1317. Questions regarding the proper method to dispose of controlled substances should be

referred to Regional Chief Pharmacists.