Compliance Inspection Report (Page 5 of 11) in pdf

Item

Requirements

YES

N/A

Comment / Observation

No.

Pharmacy Interns & Technicians, con’t.

A pharmacy technician eligible to function as a certified pharmacy technician shall wear a name tag with the individual’s

name and the title “Certified Pharmacy Technician”. (247 CMR 8.04(2)(a))

A pharmacy technician shall wear a name tag which indicates the individual’s name and the title “Pharmacy Technician”.

(247 CMR 8.02 (3) (a))

A pharmacy technician trainee shall wear a name tag with the individual’s name and the title “Pharmacy Technician

Trainee”. (247 CMR 8.03 (2) (a))

An individual may act and be designated as a pharmacy technician trainee for not more than 1000 hours, unless an

extension is granted by the Board. Pharmacy technician trainees under the age of 18 are not subject to the 1000 hour

limitation. (247 CMR 8.03 (3))

A written description of the duties delegated to certified pharmacy technicians, pharmacy technicians, and pharmacy

technician trainees shall be made available to the Board upon request. (247 CMR 8.06 (1) (b))

A written description of the scopes of responsibility for certified pharmacy technicians, pharmacy technicians, and

pharmacy technician trainees shall be made available to the Board upon request. (247 CMR 8.06 (1) (c))

Copies of pharmacy technician training program guidelines shall be provided to the Board on request.

(247 CMR 8.06 (2))

Controlled Substances Records

A pharmacist shall keep a perpetual inventory of each controlled substance in Schedules II which the pharmacist has

received, dispensed or disposed of in accordance with the law. This inventory must be reconciled at least once every ten

days. (247 CMR 9.01(14))

The responsibilities of the pharmacist Manager of Record shall include taking an inventory of controlled substances in

Schedules II, III, IV and V, based upon federal biennial inventory requirements. (247 CMR 6.07 (1) (i))

Biennial Inventory; each inventory shall contain a complete and accurate record of all controlled substances on hand on

the date the inventory is taken, and shall be maintained in written, typewritten, or printed form at the registered location,

the inventory may be taken either as of opening or as of the close of business on the inventory date and it shall be

indicated on the inventory. (247 CMR 9.01 (1)) (21 CFR 1304.11(a))

A registrant may authorize one or more individuals, whether or not located at his or her registered location, to issue

orders for Schedule II controlled substances on the registrant's behalf by executing a power of attorney for each such

individual, if the power of attorney is retained in the files, with executed Forms 222 where applicable, for the same period

as any order bearing the signature of the attorney. The power of attorney must be available for inspection together with

other order records. (247 CMR 9.01 (1)) (21 CFR 1305.05 (a))

Each DEA Form 222 must be signed and dated by a person authorized to sign an application for registration or a person

granted power of attorney to sign a Form 222 under §1305.05. The name of the purchaser, if different from the individual

signing the DEA Form 222, must also be inserted in the signature space. (247 CMR 9.01 (1)) (21 CFR 1305.12 (d))

The purchaser must record on Copy 3 of the DEA Form 222 the number of commercial or bulk containers furnished on

each item and the dates on which the containers are received by the purchaser. (247 CMR 9.01 (1))

(21 CFR 1305.13 (e))

CSOS: When a purchaser receives a shipment, the purchaser must create a record of the quantity of each item received

and the date received. The record must be electronically linked to the original order and archived. (247 CMR 9.01 (1))

(21 CFR 1305.22 (4) (g))

Compliance Inspection Report Page 5

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