Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-5 - Outpatient Pharmacies › Section 4729:5-5-23 - Security, control and storage of dangerous drugs in an outpatient pharmacy

Current through all regulations passed and filed through July 1, 2024
(A)
								The following
			 applies to an outpatient pharmacy licensed as a terminal distributor of
			 dangerous drugs:
(1)
									Except as provided in paragraph (A)(6) of this rule, a
			 pharmacist shall provide supervision of the dangerous drugs, hypodermics,
			 D.E.A. controlled substance order forms, all records relating to the
			 distribution of dangerous drugs, except where the board has granted permission
			 for such records to be stored at a secure off-site location in accordance with
			 this chapter of the Administrative Code, at all times in order to deter and
			 detect theft or diversion.
(2)
									The pharmacy
			 shall be separated from the merchandising or public areas.
(3)
									The pharmacist or
			 pharmacists on duty:
(a)
										Shall be physically present at the licensed location
			 and responsible for the security of the pharmacy and supervision of pharmacy
			 personnel.
(b)
										If the pharmacy is located within a store or business,
			 shall ensure that all dangerous drugs, controlled substances, and hypodermics
			 that are delivered onto the premises of the store or business are immediately
			 placed and secured in the pharmacy under the physical control of the pharmacist
			 or pharmacists on duty or secured in a designated area in accordance with
			 paragraph (A)(6)(i) of this rule.
(4)
									No person, other
			 than a licensed pharmacist, may enter the pharmacy unless the person is on
			 business directly concerning the operation, maintenance or repair of the
			 pharmacy and a pharmacist employed by the pharmacy is physically present at the
			 same time.
(5)
									All schedule II controlled substance dangerous drugs
			 shall be stored in a securely locked, substantially constructed cabinet or safe
			 and shall not be dispersed through the stock of dangerous drugs. The cabinet or
			 safe shall remain locked and secured when not in use. Schedule III through V
			 controlled substance dangerous drugs may be stored with Schedule II controlled
			 substance dangerous drugs.
(6)
									Whenever a
			 pharmacist cannot meet the supervision requirements in paragraph (A)(3)(a) of
			 this rule, security of the pharmacy must be provided in accordance with the
			 following:
(a)
										
			 The pharmacy must be secured by either:
(i)
											A physical
			 barrier (i.e. barricade) with suitable locks approved by the board. Except for
			 extraordinary circumstances beyond the pharmacy's control, a pharmacy shall
			 notify the board of any installation or modification to a physical barrier
			 prior to implementation.
(ii)
											An alarm system approved by the board that is monitored
			 by a central station for control and can detect unauthorized access to the
			 pharmacy. The alarm system shall be tested on a biannual basis. The pharmacy or
			 the entity that manages security for the pharmacy shall maintain testing
			 records for three years from the date of testing and shall make such records
			 readily retrievable. The pharmacy shall be responsible for obtaining testing
			 records if such records are maintained by a third-party. Except for
			 extraordinary circumstances beyond the pharmacy's control, a pharmacy shall
			 notify the board of any installation or modification to an alarm system prior
			 to implementation. This notification requirement does not apply if a pharmacy
			 also utilizes an approved physical barrier in accordance with paragraph
			 (A)(6)(a)(i) of this rule.
(b)
										Except as
			 provided in paragraph (A)(6)(i) of this rule, the pharmacy must contain all
			 dangerous drugs, hypodermics, and D.E.A. controlled substance order forms and
			 every other item or product that requires the supervision or sale by a
			 pharmacist.
(c)
										Only a licensed pharmacist may have access to keys or
			 other methods of gaining access to the pharmacy.
(i)
											Keys to the
			 pharmacy that are not in the possession of a licensed pharmacist that are
			 maintained on-site shall be secured to prevent unauthorized
			 access.
(ii)
											All combinations or access codes, including alarm
			 codes, shall be changed upon termination of employment of an employee having
			 knowledge of the combination or access code.
(d)
										All records
			 relating to the distribution of dangerous drugs must be maintained in the
			 pharmacy, except as follows:
(i)
											The board has granted permission for such records to be
			 stored at a secure off-site location in accordance with this chapter of the
			 Administrative Code; or
(ii)
											Any designated area outside the pharmacy used to store
			 records that complies with paragraph (A)(6)(i) of this rule.
(e)
										No
			 item, product, record, or equipment that must be accessible to anyone other
			 than a pharmacist may be stored in the pharmacy.
(f)
										Only a pharmacist
			 may have access to the pharmacy or stock of dangerous drugs or assume
			 responsibility for the security of dangerous drugs, hypodermics, and any other
			 item or product that requires the supervision or sale by a
			 pharmacist.
(g)
										No prescription, dangerous drug, hypodermic, nor any
			 other item or product that requires the supervision or sale by a pharmacist may
			 be sold, given away, or disposed of at any time the pharmacy is
			 closed.
(h)
										New or refill prescription orders may be deposited into
			 a secured area within the building where the pharmacy is located when a
			 pharmacist is not present. Only a pharmacist may have access to this secured
			 area.
(i)
										Any designated area outside the pharmacy at the
			 location licensed as a terminal distributor of dangerous drugs intending to be
			 used for the storage of dangerous drugs, D.E.A. controlled substance order
			 forms, hypodermics, and records relating to the distribution of dangerous
			 drugs, except where the board has granted a permission for such records to be
			 stored at a secure off-site location pursuant to this chapter of the
			 Administrative Code, and every other item or product that requires the
			 supervision or sale by a pharmacist shall meet the following
			 requirements:
(i)
											The designated area shall be secured by an approved
			 physical barrier with suitable locks to detect unauthorized entry. Except for
			 extraordinary circumstances beyond the pharmacy's control, a pharmacy shall
			 notify the board of any installation or modification to a physical barrier
			 prior to implementation.
(ii)
											No item, product, record, or equipment that must be
			 accessible to anyone other than a pharmacist may be stored in the designated
			 area, unless authorized by the board of pharmacy.
(iii)
											Authorized
			 personnel may have access if there is supervision by a
			 pharmacist.
(iv)
											No controlled substances may be stored outside of the
			 pharmacy, except as authorized under division 4729:10 of the Administrative
			 Code.
(j)
										If an outpatient pharmacy provides services by means of
			 a drive-through facility, the drive-through facility shall be constructed and
			 maintained in a manner, and with materials, that secures the premises of the
			 pharmacy from unauthorized access.