Bill Text: CA AB1139 | 2013-2014 | Regular Session | Introduced

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Bill Title: Prescriptions: biosimilar products.

Spectrum: Partisan Bill (Democrat 2-0)

Status: (Introduced - Dead) 2014-02-03 - From committee: Filed with the Chief Clerk pursuant to Joint Rule 56. [AB1139 Detail]

Download: California-2013-AB1139-Introduced.html

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BILL NUMBER: AB 1139	INTRODUCED
	BILL TEXT


INTRODUCED BY   Assembly Member Lowenthal
   (Principal coauthor: Senator DeSaulnier)

                        FEBRUARY 22, 2013

   An act to amend Section 4073 of the Business and Professions Code,
relating to pharmacy.


	LEGISLATIVE COUNSEL'S DIGEST


   AB 1139, as introduced, Lowenthal. Prescriptions: biosimilar
products.
   The Pharmacy Law governs the practice of pharmacy in this state,
including the permissible duties of licensed pharmacists. Among other
permitted acts, a pharmacist filling a prescription order for a drug
product prescribed by its trade or brand name may select another
drug product with the same active chemical ingredients of the same
strength, quantity, and dosage form, and of the same generic drug
name as determined by a specified federal entity, of those drug
products having the same active chemical ingredients. A person who
knowingly violates the Pharmacy Law is guilty of a misdemeanor, as
specified.
   This bill would authorize a pharmacist filling a prescription
order for a biological product subject to the Federal Food, Drug, and
Cosmetic Act, as specified, to select a biosimilar product, as
defined by federal statute, provided that product is deemed by the
federal Food and Drug Administration (FDA) to be interchangeable with
the prescribed product.
   Vote: majority. Appropriation: no. Fiscal committee: no.
State-mandated local program: no.


THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:

  SECTION 1.  Section 4073 of the Business and Professions Code is
amended to read:
   4073.  (a) A pharmacist filling a prescription order for a drug
product prescribed by its trade or brand name may select another drug
product with the same active chemical ingredients of the same
strength, quantity, and dosage form, and of the same generic drug
name as determined by the United States Adopted Names (USAN) and
accepted by the federal Food and Drug Administration (FDA), of those
drug products having the same active chemical ingredients. 
   (b) A pharmacist filling a prescription order for a biological
product subject to Section 503(b) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. Sec. 353(b)), may select a biosimilar
product, as defined by Section 351 of the federal Public Health
Service Act (42 U.S.C. Sec. 262), provided that product is deemed by
the FDA to be interchangeable with the prescribed product. 

   (b) 
    (   c)  In no case shall a selection be made
pursuant to this section if the prescriber personally indicates,
either orally or in his or her own handwriting, "Do not substitute,"
or words of similar meaning. Nothing in this subdivision shall
prohibit a prescriber from checking a box on a prescription marked
"Do not substitute"; provided that the prescriber personally initials
the box or checkmark. To indicate that a selection shall not be made
pursuant to this section for an electronic data transmission
prescription as defined in subdivision (c) of Section 4040, a
prescriber may indicate "Do not substitute," or words of similar
meaning, in the prescription as transmitted by electronic data, or
may check a box marked on the prescription "Do not substitute." In
either instance, it shall not be required that the prohibition on
substitution be manually initialed by the prescriber. 
   (c) 
    (d)  Selection pursuant to this section is within the
discretion of the pharmacist, except as provided in subdivision
 (b)   (c)  . The person who selects the
drug product to be dispensed pursuant to this section shall assume
the same responsibility for selecting the dispensed drug product as
would be incurred in filling a prescription for a drug product
prescribed by generic name. There shall be no liability on the
prescriber for an act or omission by a pharmacist in selecting,
preparing, or dispensing a drug product pursuant to this section. In
no case shall the pharmacist select a drug product pursuant to this
section unless the drug product selected costs the patient less than
the prescribed drug product. Cost, as used in this subdivision, is
defined to include any professional fee that may be charged by the
pharmacist. 
   (d) 
    (e)  This section shall apply to all prescriptions,
including those presented by or on behalf of persons receiving
assistance from the federal government or pursuant to the California
Medical Assistance Program set forth in Chapter 7 (commencing with
Section 14000) of Part 3 of Division 9 of the Welfare and
Institutions Code. 
   (e) 
    (f) When a substitution is made pursuant to this
section, the use of the cost-saving drug product dispensed shall be
communicated to the patient and the name of the dispensed drug
product shall be indicated on the prescription label, except where
the prescriber orders otherwise.