Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-8 - Non-resident Pharmacies › Section 4729:5-8-04 - Drugs compounded by a nonresident pharmacy

Current through all regulations passed and filed through July 1, 2024
(A)
								Except as
			 otherwise provided in this rule, the terms and references used in this rule
			 have the same meaning as in rules
			 4729:7-1-01
			 and 4729:7-2-01 of the Administrative Code.
(B)
								For all
			 non-sterile compounded drug preparations, a pharmacy licensed as a nonresident
			 terminal distributor of dangerous drugs shall comply with United States
			 pharmacopeia chapter <795>. The requirements of this rule do not apply to
			 the preparation of non-hazardous, conventionally manufactured non-sterile
			 products in accordance with the directions contained in the approved labeling
			 provided by the product's manufacturer.
(C)
								For all sterile
			 compounded drug preparations, a pharmacy licensed as a nonresident terminal
			 distributor of dangerous drugs shall comply with United States pharmacopeia
			 chapter <797>.
(D)
								For all antineoplastic compounded hazardous drug
			 preparations listed in table one on the national institute for occupational
			 safety and health's list of antineoplastic and other hazardous drugs in
			 healthcare settings as referenced in rule
			 4729:7-1-01
			 of the Administrative Code, a pharmacy licensed as a nonresident terminal
			 distributor of dangerous drugs shall comply with United States pharmacopeia
			 chapter <800>.
(E)
								For all non-antineoplastic compounded hazardous drug
			 preparations listed in table one on the national institute for occupational
			 safety and health's list of antineoplastic and other hazardous drugs in
			 healthcare settings as referenced in rule
			 4729:7-1-01
			 of the Administrative Code and for all compounded hazardous drug preparations
			 listed in table two or three on the national institute for occupational safety
			 and health's list of antineoplastic and other hazardous drugs in healthcare
			 settings as referenced in rule
			 4729:7-1-01
			 of the Administrative Code, a pharmacy licensed as a nonresident terminal
			 distributor of dangerous drugs shall comply with either:
(1)
									United States
			 pharmacopeia chapter <800>; or
(2)
									All the
			 following:
(a)
										Conduct a risk assessment for any hazardous drug
			 preparations listed in paragraph (E) of this rule to determine if any
			 additional containment strategies, work practices, and/or training is required
			 to minimize occupational exposure. Risk assessments shall be made readily
			 retrievable for review by an agent, inspector or employee of the state board of
			 pharmacy. The risk assessment must be reviewed at least every twelve months and
			 the review documented. If a risk assessment is not performed, the compounded
			 drug preparations shall be prepared in accordance with paragraph (E)(1) of this
			 rule. The risk assessment must, at a minimum, consider the following:
(i)
											Type of hazardous
			 drug (e.g., non-antineoplastic or reproductive risk only);
(ii)
											Dosage
			 form;
(iii)
											Risk of exposure;
(iv)
											Packaging;
			 and
(v)
											Manipulation.
(b)
										Ensure that any
			 employees of reproductive capability confirm in writing that they understand
			 the potential risks of handling drugs listed in paragraph (E) of this
			 rule.