N.Y. Education Law § 6811-a: Certain drugs to be clearly marked or labeled

§ 6811-a. Certain drugs to be clearly marked or labeled. 1. Except as

otherwise authorized in the Federal Food, Drug and Cosmetic Act, no drug

for which a prescription is required by the provisions of the Federal

Food, Drug and Cosmetic Act or by the commissioner of health may be

manufactured or commercially distributed within this state in tablet or

capsule form unless it has clearly marked or imprinted on each such

tablet or capsule in conformance with the applicable plan required by

subdivision three of this section:

(a) an individual symbol, number, company name, words, letters,

marking or National Drug Code (hereinafter referred to as N. D. C.)

number identifying the manufacturer or distributor of the drug; and

(b) an N. D. C. number, symbol, number, letters, words or marking

identifying such drug or combination of drugs.

2. Except as otherwise authorized in the Federal Food, Drug and

Cosmetic Act, no drug for which any prescription is required by the

provisions of the Federal Food, Drug and Cosmetic Act or by the

commissioner of health contained within a bottle, vial, carton or other

container, or in any way affixed or appended to or enclosed within a

package of any kind, and designed or intended for delivery in such

container or package to an ultimate consumer, shall be manufactured or

distributed within this state unless such container or package has

clearly and permanently marked or imprinted upon it in conformance with

the applicable plan required by subdivision three of this section:

(a) an individual symbol, N. D. C. number, company name, number,

letters, words or marking identifying the manufacturer or distributor of

the drug;

(b) an N. D. C. number, symbol, number, letters, words or marking

identifying such drug or combination of drugs; and

(c) whenever the distributor of the prescription drug product does not

also manufacture the product the names and places of business of both

shall appear on the label in words clearly distinguishing each.

3. (a) Each manufacturer and distributor shall prepare and submit to

the commissioner of health a proposed plan of the manufacturer or

distributor, as the case may be, to have its products comply with the

marking and labeling requirements of this section.

(b) Such plan shall be in writing and shall give the respective dates

by which the various products manufactured or distributed will each

contain the required mark or label. The plan shall state the reasons why

the projected date of compliance has been proposed and such other

information deemed relevant or that the commissioner of health shall

require.

(c) The commissioner may either approve the plan as proposed or, after

consultation with the manufacturer or distributor, require an amendment

or the commissioner may promulgate a plan for the manufacturer or

distributor. No plan or amendment to the plan shall be effective until

approved or promulgated by the commissioner of health upon a finding by

him that the time limitations provided for therein are reasonable and

will best carry out the intendment of this section.

4. Each manufacturer and/or distributor shall publish and make

available, upon request, to the department of education, to each

physician, dentist, pharmacy, hospital or other institution wherein such

drugs may be used, a printed material which will identify each imprint

used by the manufacturer or distributor. Updated materials shall be

provided as changes occur, upon the filing of an annual request. The

provisions of this subdivision shall be deemed to be complied with when

a prescription drug product is included in the Physician's Desk

Reference.

5. Every person, firm or corporation violating the provisions of this

section for any prescription drug product shall be guilty of an offense

punishable by a fine of not less than twenty-five hundred dollars nor

more than ten thousand dollars. Any prescription drug product prepared

or manufactured in violation of this section shall be contraband and

subject to seizure either by the state board of pharmacy or by any law

enforcement officer of the state.

6. The provisions of this section shall not apply to any tablet or

capsule which contains a controlled substance as that term is defined by

article thirty-three of the public health law or which is prepared or

manufactured by a pharmacist duly licensed by the state which is made by

him for the purpose of retail sale from his principal place of business

and not intended for resale.

7. The commissioner of health may exempt a particular tablet or

capsule from the requirements of this section, upon application by a

manufacturer, on the grounds that labeling such a tablet or capsule is

unfeasible because of size or texture or other unique characteristics.

8. (a) As used in this section, the term "distributor" means the

person, firm, corporation or other entity which is not the actual

manufacturer of a prescription drug product but which distributes such

product for resale under the label of such person, firm, corporation or

entity.

(b) For purposes of subdivision four "drug product" means the entire

supply of the finished dosage form of the drug.