§ 6831. Special provisions relating to outsourcing facilities.

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§ 6831. Special provisions relating to outsourcing facilities. 1.

Registration. Any outsourcing facility that is engaged in the

compounding of sterile drugs in this state shall be registered as an

outsourcing facility under the Federal Food, Drug and Cosmetic Act and

be registered as an outsourcing facility pursuant to this article.

2. New drugs. Sections 502(f)(1), 505 and 582 of the Federal Food,

Drug and Cosmetic Act shall not apply to a drug compounded in an

outsourcing facility registered under the Federal Food, Drug and

Cosmetic Act.

3. Prescriptions. Notwithstanding any other provision of law to the

contrary, no outsourcing facility may distribute or dispense any drug to

any person pursuant to a prescription unless it is also registered as a

pharmacy in this state and meets all other applicable requirements of

federal and state law.

4. Restrictions. Any drugs compounded in an outsourcing facility

registered pursuant to this article shall be compounded in accordance

with all applicable federal and state laws.

5. Labeling. Notwithstanding any other provision of law to the

contrary, the label of any drug compounded by an outsourcing facility

shall include, but not be limited to the following:

(a)a statement that the drug is a compounded drug or a reasonable

comparable alternative statement that prominently identifies the drug as

a compounded drug;

(b)the name, address, and phone number of the applicable outsourcing

facility; and

(c)with respect to the drug:

(i)the lot or batch number;

(ii)the established name of the drug;

(iii)the dosage form and strength;

(iv)the statement of quantity or volume, as appropriate;

(v)the date that the drug was compounded;

(vi)the expiration date;

(vii)storage and handling instructions;

(viii)the National Drug Code number, if available;

(ix)the statement that the drug is not for resale, and the statement

"Office Use Only"; and

(x)a list of the active and inactive ingredients, identified by

established name, and the quantity or proportion of each ingredient.

6. Container. The container from which the individual units of the

drug are removed for dispensing or for administration (such as a plastic

bag containing individual product syringes) shall include:

(a)a list of active and inactive ingredients, identified by

established name, and the quantity or proportion of each ingredient; and

(b)any other information required by regulations promulgated by the

commissioner to facilitate adverse event reporting in accordance with

the requirements established in section 310.305 of title 21 of the code

of federal regulations.

7. Bulk drugs. A drug may only be compounded in an outsourcing

facility that does not compound using bulk drug substances as defined in

section 207.3(a)(4) of title 21 of the code of federal regulations or

any successor regulation unless:

(a)the bulk drug substance appears on a list established by the

secretary of health and human services identifying bulk drug substances

for which there is a clinical need;

(b)the drug is compounded from a bulk drug substance that appears on

the federal drug shortage list in effect at the time of compounding,

distributing, and dispensing;

(c)if an applicable monograph exists under the United States

Pharmacopeia, the national formulary, or another compendium or

pharmacopeia recognized by the secretary of health and human services

and the bulk drug substances each comply with the monograph;

(d)the bulk drug substances are each manufactured by an establishment

that is registered with the federal government.

8. Ingredients. If an outsourcing facility uses ingredients, other

than bulk drug substances, such ingredients must comply with the

standards of the applicable United States pharmacopeia or national

formulary monograph, if such monograph exists, or of another compendium

or pharmacopeia recognized by the secretary of health and human services

for purposes of this subdivision, if any.

9. Unsafe or ineffective drugs. No outsourcing facility may compound a

drug that appears on a list published by the secretary of health and

human services that has been withdrawn or removed from the market

because such drugs or components of such drugs have been found to be

unsafe or not effective.

10. Prohibition on wholesaling. No compounded drug will be sold or

transferred by any entity other than the outsourcing facility that

compounded such drug. This does not prohibit the administration of a

drug in a health care setting or dispensing a drug pursuant to a

properly executed prescription.

11. Prohibition against copying an approved drug. No outsourcing

facility may compound a drug that is essentially a copy of one or more

approved drugs.

12. Prohibition against compounding drugs presenting demonstrable

difficulties. No outsourcing facility may compound a drug:

i. that is identified, directly or as part of a category of drugs, on

a list published by the secretary of health and human services that

present demonstrable difficulties for compounding that are reasonably

likely to lead to an adverse effect on the safety or effectiveness of

the drug or category of drugs, taking into account the risks and

benefits to patients; or

ii. that is compounded in accordance with all applicable conditions

identified on the drug list as conditions that are necessary to prevent

the drug or category of drugs from presenting demonstrable difficulties.

13. Adverse event reports. Outsourcing facilities shall submit a copy

of all adverse event reports submitted to the secretary of health and

human services in accordance with the content and format requirements

established in section 310.305 of title 21 of the code of federal

regulations, or any successor regulation, to the executive secretary for

the state board of pharmacy.

14. Reports. The commissioner, in consultation with the commissioner

of health, shall prepare and submit a report to the governor and the

legislature, due eighteen months from the effective date of this

section, evaluating the effectiveness of the registration and oversight

of outsourcing facilities related to compounding.