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This entry was published on 2014-09-22
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SECTION 6831
Special provisions relating to outsourcing facilities
Education (EDN) CHAPTER 16, TITLE 8, ARTICLE 137
§ 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.