4015. For purposes of this chapter, the definitions of the terms in
this article shall govern the construction of this chapter, unless
otherwise indicated.
4016. "Administer" means the direct application of a drug or device
to the body of a patient or research subject by injection,
inhalation, ingestion, or other means.
4017. "Authorized officers of the law" means inspectors of the
California State Board of Pharmacy, inspectors of the Food and Drug
Branch of the State Department of Public Health, and investigators of
the department's Division of Investigation or peace officers engaged
in official investigations.
4018. "Board" means the California State Board of Pharmacy.
4019. An "order," entered on the chart or medical record of a
patient registered in a hospital or a patient under emergency
treatment in the hospital, by or on the order of a practitioner
authorized by law to prescribe drugs, shall be authorization for the
administration of the drug from hospital floor or ward stocks
furnished by the hospital pharmacy or under licensure granted under
Section 4056, and shall be considered to be a prescription if the
medication is to be furnished directly to the patient by the hospital
pharmacy or another pharmacy furnishing prescribed drugs for
hospital patients; provided that the chart or medical record of the
patient contains all of the information required by Sections 4040 and
4070 and the order is signed by the practitioner authorized by law
to prescribe drugs, if he or she is present when the drugs are given.
If he or she is not present when the drugs are given, the order
shall be signed either by the attending physician responsible for the
patient's care at the time the drugs are given to the patient or by
the practitioner who ordered the drugs for the patient on the
practitioner's next visit to the hospital.
4021. "Controlled substance" means any substance listed in Chapter
2 (commencing with Section 11053) of Division 10 of the Health and
Safety Code.
4022. "Dangerous drug" or "dangerous device" means any drug or
device unsafe for self-use in humans or animals, and includes the
following:
(a) Any drug that bears the legend: "Caution: federal law
prohibits dispensing without prescription," "Rx only," or words of
similar import.
(b) Any device that bears the statement: "Caution: federal law
restricts this device to sale by or on the order of a ____," "Rx
only," or words of similar import, the blank to be filled in with the
designation of the practitioner licensed to use or order use of the
device.
(c) Any other drug or device that by federal or state law can be
lawfully dispensed only on prescription or furnished pursuant to
Section 4006.
4022.5. (a) "Designated representative" means an individual to whom
a license has been granted pursuant to Section 4053. A pharmacist
fulfilling the duties of Section 4053 shall not be required to obtain
a license as a designated representative.
(b) "Designated representative-in-charge" means a designated
representative or a pharmacist proposed by a wholesaler or veterinary
food-animal drug retailer and approved by the board as the
supervisor or manager responsible for ensuring the wholesaler's or
veterinary food-animal drug retailer's compliance with all state and
federal laws and regulations pertaining to practice in the applicable
license category.
4023. "Device" means any instrument, apparatus, machine, implant,
in vitro reagent, or contrivance, including its components, parts,
products, or the byproducts of a device, and accessories that are
used or intended for either of the following:
(a) Use in the diagnosis, cure, mitigation, treatment, or
prevention of disease in a human or any other animal.
(b) To affect the structure or any function of the body of a human
or any other animal.
For purposes of this chapter, "device" does not include contact
lenses, or any prosthetic or orthopedic device that does not require
a prescription.
4023.5. For the purposes of this chapter, "direct supervision and
control" means that a pharmacist is on the premises at all times and
is fully aware of all activities performed by either a pharmacy
technician or intern pharmacist.
4024. (a) Except as provided in subdivision (b), "dispense" means
the furnishing of drugs or devices upon a prescription from a
physician, dentist, optometrist, podiatrist, veterinarian, or
naturopathic doctor pursuant to Section 3640.7, or upon an order to
furnish drugs or transmit a prescription from a certified
nurse-midwife, nurse practitioner, physician assistant, naturopathic
doctor pursuant to Section 3640.5, or pharmacist acting within the
scope of his or her practice.
(b) "Dispense" also means and refers to the furnishing of drugs or
devices directly to a patient by a physician, dentist, optometrist,
podiatrist, or veterinarian, or by a certified nurse-midwife, nurse
practitioner, naturopathic doctor, or physician assistant acting
within the scope of his or her practice.
4025. "Drug" means any of the following:
(a) Articles recognized in the official United States
Pharmacopoeia, official National Formulary or official Homeopathic
Pharmacopoeia of the United States, or any supplement of any of them.
(b) Articles intended for use in the diagnosis, cure, mitigation,
treatment, or prevention of disease in humans or other animals.
(c) Articles (other than food) intended to affect the structure or
any function of the body of humans or other animals.
(d) Articles intended for use as a component of any article
specified in subdivision (a), (b), or (c).
4025.1. "Nonprescription drug" means a drug which may be sold
without a prescription and which is labeled for use by the consumer
in accordance with the requirements of the laws and rules of this
state and the federal government.
4026. "Furnish" means to supply by any means, by sale or otherwise.
4026.5. "Good standing" means a license issued by the board that is
unrestricted by disciplinary action taken pursuant to Chapter 5
(commencing with Section 11500) of Part 1 of Division 3 of Title 2 of
the Government Code.
4027. (a) As used in this chapter, the terms "skilled nursing
facility," "intermediate care facility," and other references to
health facilities shall be construed with respect to the definitions
contained in Article 1 (commencing with Section 1250) of Chapter 2 of
Division 2 of the Health and Safety Code.
(b) As used in Section 4052.1, "licensed health care facility"
means a facility licensed pursuant to Article 1 (commencing with
Section 1250) of Chapter 2 of Division 2 of the Health and Safety
Code or a facility, as defined in Section 1250 of the Health and
Safety Code, operated by a health care service plan licensed pursuant
to Chapter 2.2 (commencing with Section 1340) of Division 2 of the
Health and Safety Code.
(c) As used in Section 4052.2, "health care facility" means a
facility, other than a facility licensed under Division 2 (commencing
with Section 1200) of the Health and Safety Code, that is owned or
operated by a health care service plan licensed pursuant to Chapter
2.2 (commencing with Section 1340) of the Health and Safety Code, or
by an organization under common ownership or control of the health
care service plan; "licensed home health agency" means a private or
public organization licensed by the State Department of Public Health
pursuant to Chapter 8 (commencing with Section 1725) of Division 2
of the Health and Safety Code, as further defined in Section 1727 of
the Health and Safety Code; and "licensed clinic" means a clinic
licensed pursuant to Article 1 (commencing with Section 1200) of
Chapter 1 of Division 2 of the Health and Safety Code.
(d) "Licensed health care facility" or "facility," as used in
Section 4065, means a health facility licensed pursuant to Article 1
(commencing with Section 1250) of Chapter 2 of Division 2 of the
Health and Safety Code or a facility that is owned or operated by a
health care service plan licensed pursuant to Chapter 2.2 (commencing
with Section 1340) of Division 2 of the Health and Safety Code or by
an organization under common ownership or control with the health
care service plan.
4028. "Licensed hospital" means an institution, place, building, or
agency that maintains and operates organized facilities for one or
more persons for the diagnosis, care, and treatment of human
illnesses to which persons may be admitted for overnight stay, and
includes any institution classified under regulations issued by the
State Department of Public Health as a general or specialized
hospital, as a maternity hospital, or as a tuberculosis hospital, but
does not include a sanitarium, rest home, a nursing or convalescent
home, a maternity home, or an institution for treating alcoholics.
4029. (a) "Hospital pharmacy" means and includes a pharmacy,
licensed by the board, located within any licensed hospital,
institution, or establishment that maintains and operates organized
facilities for the diagnosis, care, and treatment of human illnesses
to which persons may be admitted for overnight stay and that meets
all of the requirements of this chapter and the rules and regulations
of the board.
(b) A hospital pharmacy also includes a pharmacy that may be
located outside of the hospital, in another physical plant that is
regulated under a hospital's consolidated license issued pursuant to
Section 1250.8 of the Health and Safety Code. As a condition of
licensure by the board, the pharmacy in another physical plant shall
provide pharmaceutical services only to registered hospital patients
who are on the premises of the same physical plant in which the
pharmacy is located. The pharmacy services provided shall be directly
related to the services or treatment plan administered in the
physical plant. Nothing in this paragraph shall be construed to
restrict or expand the services that a hospital pharmacy may provide.
4030. "Intern pharmacist" means a person issued a license pursuant
to Section 4208.
4031. "Laboratory" means a research, teaching, or testing
laboratory not engaged in the dispensing or furnishing of drugs or
devices but using dangerous drugs or dangerous devices for scientific
or teaching purposes. Every laboratory shall maintain an established
place of business and keep purchase records. Every laboratory shall
be subject to the jurisdiction of the board.
4032. "License" means and includes any license, permit,
registration, certificate, or exemption issued by the board and
includes the process of applying for and renewing the same.
4033. (a) (1) "Manufacturer" means and includes every person who
prepares, derives, produces, compounds, or repackages any drug or
device except a pharmacy that manufactures on the immediate premises
where the drug or device is sold to the ultimate consumer.
(2) Notwithstanding paragraph (1), "manufacturer" shall not mean a
pharmacy compounding a drug for parenteral therapy, pursuant to a
prescription, for delivery to another pharmacy for the purpose of
delivering or administering the drug to the patient or patients named
in the prescription, provided that neither the components for the
drug nor the drug are compounded, fabricated, packaged, or otherwise
prepared prior to receipt of the prescription.
(3) Notwithstanding paragraph (1), "manufacturer" shall not mean a
pharmacy that, at a patient's request, repackages a drug previously
dispensed to the patient, or to the patient's agent, pursuant to a
prescription.
(b) Notwithstanding subdivision (a), as used in Sections 4034,
4163, 4163.1, 4163.2, 4163.3, 4163.4, and 4163.5, "manufacturer"
means a person who prepares, derives, manufactures, produces, or
repackages a dangerous drug, as defined in Section 4022, device, or
cosmetic. Manufacturer also means the holder or holders of a New Drug
Application (NDA), an Abbreviated New Drug Application (ANDA), or a
Biologics License Application (BLA), provided that such application
has been approved; a manufacturer's third party logistics provider; a
private label distributor (including colicensed partners) for whom
the private label distributor's prescription drugs are originally
manufactured and labeled for the distributor and have not been
repackaged; or the distributor agent for the manufacturer, contract
manufacturer, or private label distributor, whether the establishment
is a member of the manufacturer's affiliated group (regardless of
whether the member takes title to the drug) or is a contract
distributor site.
4034. (a) "Pedigree" means a record, in electronic form, containing
information regarding each transaction resulting in a change of
ownership of a given dangerous drug, from sale by a manufacturer,
through acquisition and sale by one or more wholesalers,
manufacturers, repackagers, or pharmacies, until final sale to a
pharmacy or other person furnishing, administering, or dispensing the
dangerous drug. The pedigree shall be created and maintained in an
interoperable electronic system, ensuring compatibility throughout
all stages of distribution.
(b) A pedigree shall include all of the following information:
(1) The source of the dangerous drug, including the name, the
federal manufacturer's registration number or a state license number
as determined by the board, and principal address of the source.
(2) The trade or generic name of the dangerous drug, the quantity
of the dangerous drug, its dosage form and strength, the date of the
transaction, the sales invoice number or, if not immediately
available, a customer-specific shipping reference number linked to
the sales invoice number, the container size, the number of
containers, the expiration dates, and the lot numbers.
(3) The business name, address, and the federal manufacturer's
registration number or a state license number as determined by the
board, of each owner of the dangerous drug, and the dangerous drug
shipping information, including the name and address of each person
certifying delivery or receipt of the dangerous drug.
(4) A certification under penalty of perjury from a responsible
party of the source of the dangerous drug that the information
contained in the pedigree is true and accurate.
(5) The unique identification number described in subdivision (i).
(c) A single pedigree shall include every change of ownership of a
given dangerous drug from its initial manufacture through to its
final transaction to a pharmacy or other person for furnishing,
administering, or dispensing the drug, regardless of repackaging or
assignment of another National Drug Code (NDC) Directory number.
Dangerous drugs that are repackaged shall be serialized by the
repackager and a pedigree shall be provided that references the
pedigree of the original package or packages provided by the
manufacturer.
(d) A pedigree shall track each dangerous drug at the smallest
package or immediate container distributed by the manufacturer,
received and distributed by the wholesaler or repackager, and
received by the pharmacy or another person furnishing, administering,
or dispensing the dangerous drug. For purposes of this section, the
"smallest package or immediate container" of a dangerous drug shall
include any dangerous drug package or container made available to a
repackager, wholesaler, pharmacy, or other entity for repackaging or
redistribution, as well as the smallest unit made by the manufacturer
for sale to the pharmacy or other person furnishing, administering,
or dispensing the drug.
(e) Any return of a dangerous drug to a wholesaler or manufacturer
shall be documented on the same pedigree as the transaction that
resulted in the receipt of the drug by the party returning it.
(f) If a licensed health care service plan, hospital organization,
and one or more physician organizations have exclusive contractual
relationships to provide health care services, drugs distributed
between these persons shall be deemed not to have changed ownership.
(g) The following transactions are exempt from the pedigree
requirement created by this section:
(1) An intracompany sale or transfer of a dangerous drug. For
purposes of this section, "intracompany sale or transfer" means any
transaction for any valid business purpose between a division,
subsidiary, parent, or affiliated or related company under the common
ownership and control of the same corporate or legal entity.
(2) Dangerous drugs received by the state or a local government
entity from a department or agency of the federal government or an
agent of the federal government specifically authorized to deliver
dangerous drugs to the state or local government entity.
(3) The provision of samples of dangerous drugs by a manufacturer'
s employee to an authorized prescriber, provided the samples are
dispensed to a patient of the prescriber without charge.
(4) (A) A sale, trade, or transfer of a radioactive drug, as
defined in Section 1708.3 of Title 16 of the California Code of
Regulations, between any two entities licensed by the Radiologic
Health Branch of the State Department of Public Health, the federal
Nuclear Regulatory Commission, or an Agreement state.
(B) The exemption in this paragraph shall remain in effect unless
the board, no earlier than the date that is two years after the
compliance date for manufacturers set forth in subdivision (k) of
Section 4034 or Section 4163.5, determines after consultation with
the Radiologic Health Branch of the State Department of Public Health
that the risk of counterfeiting or diversion of a radioactive drug
is sufficient to require a pedigree. Two years following the date of
any such determination, this paragraph shall become inoperative.
(5) The sale, trade, or transfer of a dangerous drug that is
labeled by the manufacturer as "for veterinary use only."
(6) The sale, trade, or transfer of compressed medical gas. For
purposes of this section, "compressed medical gas" means any
substance in its gaseous or cryogenic liquid form that meets medical
purity standards and has application in a medical or homecare
environment, including, but not limited to, oxygen and nitrous oxide.
(7) The sale, trade, or transfer of solutions. For purposes of
this section, "solutions" means any of the following:
(A) Those intravenous products that, by their formulation, are
intended for the replenishment of fluids and electrolytes, such as
sodium, chloride, and potassium, calories, such as dextrose and amino
acids, or both.
(B) Those intravenous products used to maintain the equilibrium of
water and minerals in the body, such as dialysis solutions.
(C) Products that are intended for irrigation or reconstitution,
as well as sterile water, whether intended for those purposes or for
injection.
(8) Dangerous drugs that are placed in a sealed package with a
medical device or medical supplies at the point of first shipment
into commerce by the manufacturer and the package remains sealed
until the drug and device are used, provided that the package is only
used for surgical purposes.
(9) A product that meets either of the following criteria:
(A) A product comprised of two or more regulated components, such
as a drug/device, biologic/device, or drug/device/biologic, that are
physically, chemically, or otherwise combined or mixed and produced
as a single entity.
(B) Two or more separate products packaged together in a single
package or as a unit and comprised of drug and device products or
device and biological products.
(h) If a manufacturer, wholesaler, or pharmacy has reasonable
cause to believe that a dangerous drug in, or having been in, its
possession is counterfeit or the subject of a fraudulent transaction,
the manufacturer, wholesaler, or pharmacy shall notify the board
within 72 hours of obtaining that knowledge. This subdivision shall
apply to any dangerous drug that has been sold or distributed in or
through this state.
(i) "Interoperable electronic system" as used in this chapter
means an electronic track and trace system for dangerous drugs that
uses a unique identification number, established at the point of
manufacture and supplemented by a linked unique identification number
in the event that drug is repackaged, contained within a
standardized nonproprietary data format and architecture, that is
uniformly used by manufacturers, wholesalers, repackagers, and
pharmacies for the pedigree of a dangerous drug. No particular data
carrier or other technology is mandated to accomplish the attachment
of the unique identification number described in this subdivision.
(j) The application of the pedigree requirement shall be subject
to review during the board's evaluation pursuant to Section 473.4.
(k) This section shall become operative on January 1, 2015.
4034.1. (a) (1) Upon the effective date of federal legislation or
adoption of a federal regulation addressing pedigree or serialization
measures for dangerous drugs, Sections 4034, 4163, 4163.1, 4163.2,
4163.4, and 4163.5 shall become inoperative.
(2) Within 90 days of the enactment of federal legislation or
adoption of a regulation addressing pedigree or serialization
measures for dangerous drugs, the board shall publish a notice that
Sections 4034, 4163, 4163.1, 4163.2, 4163.4, and 4163.5 are
inoperative.
(3) Within 90 days of the enactment of federal legislation or
adoption of a regulation that is inconsistent with any provision of
California law governing the application of any pedigree or
serialization requirement or standard, the board shall adopt
emergency regulations necessary to reflect the inoperation of state
law.
(b) (1) If the Food and Drug Administration (FDA) enacts any rule,
standard, or takes any other action that is inconsistent with any
provision of California law governing application of a pedigree to a
dangerous drug, that provision of California law shall be
inoperative.
(2) Within 90 days of the FDA enacting any rule, standard, or
taking any other action that is inconsistent with any provision of
California law governing application of a pedigree to a dangerous
drug, the board shall publish a notice that the provision is
inoperative.
(3) Within 90 days of the FDA enacting any rule, standard, or
taking any other action that is inconsistent with any provision of
California law governing application of a pedigree to a dangerous
drug, the board shall adopt emergency regulations necessary to
reflect the inoperation of state law.
(c) If the board fails to recognize the inoperation within 90 days
pursuant to this section, nothing in this section shall preclude a
party from filing an action in state or federal court for declaratory
or injunctive relief as an alternative to filing a petition with the
board.
4035. "Person" includes firm, association, partnership,
corporation, limited liability company, state governmental agency, or
political subdivision.
4036. "Pharmacist" means a natural person to whom a license has
been issued by the board, under Section 4200, except as specifically
provided otherwise in this chapter. The holder of an unexpired and
active pharmacist license issued by the board is entitled to practice
pharmacy as defined by this chapter, within or outside of a licensed
pharmacy as authorized by this chapter.
4036.5. "Pharmacist-in-charge" means a pharmacist proposed by a
pharmacy and approved by the board as the supervisor or manager
responsible for ensuring the pharmacy's compliance with all state and
federal laws and regulations pertaining to the practice of pharmacy.
4037. (a) "Pharmacy" means an area, place, or premises licensed by
the board in which the profession of pharmacy is practiced and where
prescriptions are compounded. "Pharmacy" includes, but is not limited
to, any area, place, or premises described in a license issued by
the board wherein controlled substances, dangerous drugs, or
dangerous devices are stored, possessed, prepared, manufactured,
derived, compounded, or repackaged, and from which the controlled
substances, dangerous drugs, or dangerous devices are furnished,
sold, or dispensed at retail.
(b) "Pharmacy" shall not include any area in a facility licensed
by the State Department of Public Health where floor supplies, ward
supplies, operating room supplies, or emergency room supplies of
dangerous drugs or dangerous devices are stored or possessed solely
for treatment of patients registered for treatment in the facility or
for treatment of patients receiving emergency care in the facility.
4038. (a) "Pharmacy technician" means an individual who assists a
pharmacist in a pharmacy in the performance of his or her pharmacy
related duties, as specified in Section 4115.
(b) A "pharmacy technician trainee" is a person who is enrolled in
a pharmacy technician training program operated by a California
public postsecondary education institution or by a private
postsecondary vocational institution approved by the Bureau for
Private Postsecondary and Vocational Education.
4039. "Physicians," "dentists," "optometrists," "pharmacists,"
"podiatrists," "veterinarians," "veterinary surgeons," "registered
nurses," "naturopathic doctors," and "physician's assistants" are
persons authorized by a currently valid and unrevoked license to
practice their respective professions in this state. "Physician"
means and includes any person holding a valid and unrevoked physician'
s and surgeon's certificate or certificate to practice medicine and
surgery, issued by the Medical Board of California or the Osteopathic
Medical Board of California, and includes an unlicensed person
lawfully practicing medicine pursuant to Section 2065, when acting
within the scope of that section.
4040. (a) "Prescription" means an oral, written, or electronic
transmission order that is both of the following:
(1) Given individually for the person or persons for whom ordered
that includes all of the following:
(A) The name or names and address of the patient or patients.
(B) The name and quantity of the drug or device prescribed and the
directions for use.
(C) The date of issue.
(D) Either rubber stamped, typed, or printed by hand or typeset,
the name, address, and telephone number of the prescriber, his or her
license classification, and his or her federal registry number, if a
controlled substance is prescribed.
(E) A legible, clear notice of the condition or purpose for which
the drug is being prescribed, if requested by the patient or
patients.
(F) If in writing, signed by the prescriber issuing the order, or
the certified nurse-midwife, nurse practitioner, physician assistant,
or naturopathic doctor who issues a drug order pursuant to Section
2746.51, 2836.1, 3502.1, or 3640.5, respectively, or the pharmacist
who issues a drug order pursuant to either Section 4052.1 or 4052.2.
(2) Issued by a physician, dentist, optometrist, podiatrist,
veterinarian, or naturopathic doctor pursuant to Section 3640.7 or,
if a drug order is issued pursuant to Section 2746.51, 2836.1,
3502.1, or 3460.5, by a certified nurse-midwife, nurse practitioner,
physician assistant, or naturopathic doctor licensed in this state,
or pursuant to either Section 4052.1 or 4052.2 by a pharmacist
licensed in this state.
(b) Notwithstanding subdivision (a), a written order of the
prescriber for a dangerous drug, except for any Schedule II
controlled substance, that contains at least the name and signature
of the prescriber, the name and address of the patient in a manner
consistent with paragraph (2) of subdivision (a) of Section 11164 of
the Health and Safety Code, the name and quantity of the drug
prescribed, directions for use, and the date of issue may be treated
as a prescription by the dispensing pharmacist as long as any
additional information required by subdivision (a) is readily
retrievable in the pharmacy. In the event of a conflict between this
subdivision and Section 11164 of the Health and Safety Code, Section
11164 of the Health and Safety Code shall prevail.
(c) "Electronic transmission prescription" includes both image and
data prescriptions. "Electronic image transmission prescription"
means any prescription order for which a facsimile of the order is
received by a pharmacy from a licensed prescriber. "Electronic data
transmission prescription" means any prescription order, other than
an electronic image transmission prescription, that is electronically
transmitted from a licensed prescriber to a pharmacy.
(d) The use of commonly used abbreviations shall not invalidate an
otherwise valid prescription.
(e) Nothing in the amendments made to this section (formerly
Section 4036) at the 1969 Regular Session of the Legislature shall be
construed as expanding or limiting the right that a chiropractor,
while acting within the scope of his or her license, may have to
prescribe a device.
4040.5. "Reverse distributor" means every person who acts as an
agent for pharmacies, drug wholesalers, manufacturers, and other
entities by receiving, inventorying, and managing the disposition of
outdated or nonsalable dangerous drugs.
4041. "Veterinary food-animal drug retailer" is an area, place, or
premises, other than a pharmacy, that holds a valid license from the
Board of Pharmacy of the State of California as a wholesaler and, in
and from which veterinary drugs for food-producing animals are
dispensed pursuant to a prescription from a licensed veterinarian.
"Veterinary food-animal retailer" includes, but is not limited to,
any area, place, or premises described in a permit issued by the
board wherein veterinary food-animal drugs, as defined in Section
4042, are stored, possessed, or repackaged, and from which veterinary
drugs are furnished, sold, or dispensed at retail pursuant to a
prescription from a licensed veterinarian.
4042. "Veterinary food-animal drugs" as used in this chapter shall
include the following:
(a) Any drug to be used in food-producing animals bearing the
legend, "Caution, federal law restricts this drug to use by or on the
order of a licensed veterinarian" or words of similar import.
(b) Any other drug as defined in Section 14206 of the Food and
Agricultural Code that is used in a manner that would require a
veterinary prescription.
4043. (a) "Wholesaler" means and includes a person who acts as a
wholesale merchant, broker, jobber, customs broker, reverse
distributor, agent, or a nonresident wholesaler, who sells for
resale, or negotiates for distribution, or takes possession of, any
drug or device included in Section 4022. Unless otherwise authorized
by law, a wholesaler may not store, warehouse, or authorize the
storage or warehousing of drugs with any person or at any location
not licensed by the board.
(b) This section shall become operative January 1, 2006.
4044. "Repackager" means a person or entity that is registered with
the federal Food and Drug Administration as a repackager and
operates an establishment that packages finished drugs from bulk or
that repackages dangerous drugs into different containers, excluding
shipping containers.
4045. "Third-party logistics provider" or "reverse third-party
logistic provider" means an entity licensed as a wholesaler that
contracts with a dangerous drug manufacturer to provide or coordinate
warehousing, distribution, or other similar services on behalf of a
manufacturer, but for which there is no change of ownership in the
dangerous drugs. For purposes of Sections 4034, 4163, 4163.1, 4163.2,
4163.3, 4163.4, and 4163.5, a third-party logistics provider shall
not be responsible for generating or updating pedigree documentation,
but shall maintain copies of the pedigree. To be exempt from
documentation for pedigrees, a reverse third-party logistic provider
may only accept decommissioned drugs from pharmacies or wholesalers.
4015. For purposes of this chapter, the definitions of the terms in
this article shall govern the construction of this chapter, unless
otherwise indicated.
4016. "Administer" means the direct application of a drug or device
to the body of a patient or research subject by injection,
inhalation, ingestion, or other means.
4017. "Authorized officers of the law" means inspectors of the
California State Board of Pharmacy, inspectors of the Food and Drug
Branch of the State Department of Public Health, and investigators of
the department's Division of Investigation or peace officers engaged
in official investigations.
4018. "Board" means the California State Board of Pharmacy.
4019. An "order," entered on the chart or medical record of a
patient registered in a hospital or a patient under emergency
treatment in the hospital, by or on the order of a practitioner
authorized by law to prescribe drugs, shall be authorization for the
administration of the drug from hospital floor or ward stocks
furnished by the hospital pharmacy or under licensure granted under
Section 4056, and shall be considered to be a prescription if the
medication is to be furnished directly to the patient by the hospital
pharmacy or another pharmacy furnishing prescribed drugs for
hospital patients; provided that the chart or medical record of the
patient contains all of the information required by Sections 4040 and
4070 and the order is signed by the practitioner authorized by law
to prescribe drugs, if he or she is present when the drugs are given.
If he or she is not present when the drugs are given, the order
shall be signed either by the attending physician responsible for the
patient's care at the time the drugs are given to the patient or by
the practitioner who ordered the drugs for the patient on the
practitioner's next visit to the hospital.
4021. "Controlled substance" means any substance listed in Chapter
2 (commencing with Section 11053) of Division 10 of the Health and
Safety Code.
4022. "Dangerous drug" or "dangerous device" means any drug or
device unsafe for self-use in humans or animals, and includes the
following:
(a) Any drug that bears the legend: "Caution: federal law
prohibits dispensing without prescription," "Rx only," or words of
similar import.
(b) Any device that bears the statement: "Caution: federal law
restricts this device to sale by or on the order of a ____," "Rx
only," or words of similar import, the blank to be filled in with the
designation of the practitioner licensed to use or order use of the
device.
(c) Any other drug or device that by federal or state law can be
lawfully dispensed only on prescription or furnished pursuant to
Section 4006.
4022.5. (a) "Designated representative" means an individual to whom
a license has been granted pursuant to Section 4053. A pharmacist
fulfilling the duties of Section 4053 shall not be required to obtain
a license as a designated representative.
(b) "Designated representative-in-charge" means a designated
representative or a pharmacist proposed by a wholesaler or veterinary
food-animal drug retailer and approved by the board as the
supervisor or manager responsible for ensuring the wholesaler's or
veterinary food-animal drug retailer's compliance with all state and
federal laws and regulations pertaining to practice in the applicable
license category.
4023. "Device" means any instrument, apparatus, machine, implant,
in vitro reagent, or contrivance, including its components, parts,
products, or the byproducts of a device, and accessories that are
used or intended for either of the following:
(a) Use in the diagnosis, cure, mitigation, treatment, or
prevention of disease in a human or any other animal.
(b) To affect the structure or any function of the body of a human
or any other animal.
For purposes of this chapter, "device" does not include contact
lenses, or any prosthetic or orthopedic device that does not require
a prescription.
4023.5. For the purposes of this chapter, "direct supervision and
control" means that a pharmacist is on the premises at all times and
is fully aware of all activities performed by either a pharmacy
technician or intern pharmacist.
4024. (a) Except as provided in subdivision (b), "dispense" means
the furnishing of drugs or devices upon a prescription from a
physician, dentist, optometrist, podiatrist, veterinarian, or
naturopathic doctor pursuant to Section 3640.7, or upon an order to
furnish drugs or transmit a prescription from a certified
nurse-midwife, nurse practitioner, physician assistant, naturopathic
doctor pursuant to Section 3640.5, or pharmacist acting within the
scope of his or her practice.
(b) "Dispense" also means and refers to the furnishing of drugs or
devices directly to a patient by a physician, dentist, optometrist,
podiatrist, or veterinarian, or by a certified nurse-midwife, nurse
practitioner, naturopathic doctor, or physician assistant acting
within the scope of his or her practice.
4025. "Drug" means any of the following:
(a) Articles recognized in the official United States
Pharmacopoeia, official National Formulary or official Homeopathic
Pharmacopoeia of the United States, or any supplement of any of them.
(b) Articles intended for use in the diagnosis, cure, mitigation,
treatment, or prevention of disease in humans or other animals.
(c) Articles (other than food) intended to affect the structure or
any function of the body of humans or other animals.
(d) Articles intended for use as a component of any article
specified in subdivision (a), (b), or (c).
4025.1. "Nonprescription drug" means a drug which may be sold
without a prescription and which is labeled for use by the consumer
in accordance with the requirements of the laws and rules of this
state and the federal government.
4026. "Furnish" means to supply by any means, by sale or otherwise.
4026.5. "Good standing" means a license issued by the board that is
unrestricted by disciplinary action taken pursuant to Chapter 5
(commencing with Section 11500) of Part 1 of Division 3 of Title 2 of
the Government Code.
4027. (a) As used in this chapter, the terms "skilled nursing
facility," "intermediate care facility," and other references to
health facilities shall be construed with respect to the definitions
contained in Article 1 (commencing with Section 1250) of Chapter 2 of
Division 2 of the Health and Safety Code.
(b) As used in Section 4052.1, "licensed health care facility"
means a facility licensed pursuant to Article 1 (commencing with
Section 1250) of Chapter 2 of Division 2 of the Health and Safety
Code or a facility, as defined in Section 1250 of the Health and
Safety Code, operated by a health care service plan licensed pursuant
to Chapter 2.2 (commencing with Section 1340) of Division 2 of the
Health and Safety Code.
(c) As used in Section 4052.2, "health care facility" means a
facility, other than a facility licensed under Division 2 (commencing
with Section 1200) of the Health and Safety Code, that is owned or
operated by a health care service plan licensed pursuant to Chapter
2.2 (commencing with Section 1340) of the Health and Safety Code, or
by an organization under common ownership or control of the health
care service plan; "licensed home health agency" means a private or
public organization licensed by the State Department of Public Health
pursuant to Chapter 8 (commencing with Section 1725) of Division 2
of the Health and Safety Code, as further defined in Section 1727 of
the Health and Safety Code; and "licensed clinic" means a clinic
licensed pursuant to Article 1 (commencing with Section 1200) of
Chapter 1 of Division 2 of the Health and Safety Code.
(d) "Licensed health care facility" or "facility," as used in
Section 4065, means a health facility licensed pursuant to Article 1
(commencing with Section 1250) of Chapter 2 of Division 2 of the
Health and Safety Code or a facility that is owned or operated by a
health care service plan licensed pursuant to Chapter 2.2 (commencing
with Section 1340) of Division 2 of the Health and Safety Code or by
an organization under common ownership or control with the health
care service plan.
4028. "Licensed hospital" means an institution, place, building, or
agency that maintains and operates organized facilities for one or
more persons for the diagnosis, care, and treatment of human
illnesses to which persons may be admitted for overnight stay, and
includes any institution classified under regulations issued by the
State Department of Public Health as a general or specialized
hospital, as a maternity hospital, or as a tuberculosis hospital, but
does not include a sanitarium, rest home, a nursing or convalescent
home, a maternity home, or an institution for treating alcoholics.
4029. (a) "Hospital pharmacy" means and includes a pharmacy,
licensed by the board, located within any licensed hospital,
institution, or establishment that maintains and operates organized
facilities for the diagnosis, care, and treatment of human illnesses
to which persons may be admitted for overnight stay and that meets
all of the requirements of this chapter and the rules and regulations
of the board.
(b) A hospital pharmacy also includes a pharmacy that may be
located outside of the hospital, in another physical plant that is
regulated under a hospital's consolidated license issued pursuant to
Section 1250.8 of the Health and Safety Code. As a condition of
licensure by the board, the pharmacy in another physical plant shall
provide pharmaceutical services only to registered hospital patients
who are on the premises of the same physical plant in which the
pharmacy is located. The pharmacy services provided shall be directly
related to the services or treatment plan administered in the
physical plant. Nothing in this paragraph shall be construed to
restrict or expand the services that a hospital pharmacy may provide.
4030. "Intern pharmacist" means a person issued a license pursuant
to Section 4208.
4031. "Laboratory" means a research, teaching, or testing
laboratory not engaged in the dispensing or furnishing of drugs or
devices but using dangerous drugs or dangerous devices for scientific
or teaching purposes. Every laboratory shall maintain an established
place of business and keep purchase records. Every laboratory shall
be subject to the jurisdiction of the board.
4032. "License" means and includes any license, permit,
registration, certificate, or exemption issued by the board and
includes the process of applying for and renewing the same.
4033. (a) (1) "Manufacturer" means and includes every person who
prepares, derives, produces, compounds, or repackages any drug or
device except a pharmacy that manufactures on the immediate premises
where the drug or device is sold to the ultimate consumer.
(2) Notwithstanding paragraph (1), "manufacturer" shall not mean a
pharmacy compounding a drug for parenteral therapy, pursuant to a
prescription, for delivery to another pharmacy for the purpose of
delivering or administering the drug to the patient or patients named
in the prescription, provided that neither the components for the
drug nor the drug are compounded, fabricated, packaged, or otherwise
prepared prior to receipt of the prescription.
(3) Notwithstanding paragraph (1), "manufacturer" shall not mean a
pharmacy that, at a patient's request, repackages a drug previously
dispensed to the patient, or to the patient's agent, pursuant to a
prescription.
(b) Notwithstanding subdivision (a), as used in Sections 4034,
4163, 4163.1, 4163.2, 4163.3, 4163.4, and 4163.5, "manufacturer"
means a person who prepares, derives, manufactures, produces, or
repackages a dangerous drug, as defined in Section 4022, device, or
cosmetic. Manufacturer also means the holder or holders of a New Drug
Application (NDA), an Abbreviated New Drug Application (ANDA), or a
Biologics License Application (BLA), provided that such application
has been approved; a manufacturer's third party logistics provider; a
private label distributor (including colicensed partners) for whom
the private label distributor's prescription drugs are originally
manufactured and labeled for the distributor and have not been
repackaged; or the distributor agent for the manufacturer, contract
manufacturer, or private label distributor, whether the establishment
is a member of the manufacturer's affiliated group (regardless of
whether the member takes title to the drug) or is a contract
distributor site.
4034. (a) "Pedigree" means a record, in electronic form, containing
information regarding each transaction resulting in a change of
ownership of a given dangerous drug, from sale by a manufacturer,
through acquisition and sale by one or more wholesalers,
manufacturers, repackagers, or pharmacies, until final sale to a
pharmacy or other person furnishing, administering, or dispensing the
dangerous drug. The pedigree shall be created and maintained in an
interoperable electronic system, ensuring compatibility throughout
all stages of distribution.
(b) A pedigree shall include all of the following information:
(1) The source of the dangerous drug, including the name, the
federal manufacturer's registration number or a state license number
as determined by the board, and principal address of the source.
(2) The trade or generic name of the dangerous drug, the quantity
of the dangerous drug, its dosage form and strength, the date of the
transaction, the sales invoice number or, if not immediately
available, a customer-specific shipping reference number linked to
the sales invoice number, the container size, the number of
containers, the expiration dates, and the lot numbers.
(3) The business name, address, and the federal manufacturer's
registration number or a state license number as determined by the
board, of each owner of the dangerous drug, and the dangerous drug
shipping information, including the name and address of each person
certifying delivery or receipt of the dangerous drug.
(4) A certification under penalty of perjury from a responsible
party of the source of the dangerous drug that the information
contained in the pedigree is true and accurate.
(5) The unique identification number described in subdivision (i).
(c) A single pedigree shall include every change of ownership of a
given dangerous drug from its initial manufacture through to its
final transaction to a pharmacy or other person for furnishing,
administering, or dispensing the drug, regardless of repackaging or
assignment of another National Drug Code (NDC) Directory number.
Dangerous drugs that are repackaged shall be serialized by the
repackager and a pedigree shall be provided that references the
pedigree of the original package or packages provided by the
manufacturer.
(d) A pedigree shall track each dangerous drug at the smallest
package or immediate container distributed by the manufacturer,
received and distributed by the wholesaler or repackager, and
received by the pharmacy or another person furnishing, administering,
or dispensing the dangerous drug. For purposes of this section, the
"smallest package or immediate container" of a dangerous drug shall
include any dangerous drug package or container made available to a
repackager, wholesaler, pharmacy, or other entity for repackaging or
redistribution, as well as the smallest unit made by the manufacturer
for sale to the pharmacy or other person furnishing, administering,
or dispensing the drug.
(e) Any return of a dangerous drug to a wholesaler or manufacturer
shall be documented on the same pedigree as the transaction that
resulted in the receipt of the drug by the party returning it.
(f) If a licensed health care service plan, hospital organization,
and one or more physician organizations have exclusive contractual
relationships to provide health care services, drugs distributed
between these persons shall be deemed not to have changed ownership.
(g) The following transactions are exempt from the pedigree
requirement created by this section:
(1) An intracompany sale or transfer of a dangerous drug. For
purposes of this section, "intracompany sale or transfer" means any
transaction for any valid business purpose between a division,
subsidiary, parent, or affiliated or related company under the common
ownership and control of the same corporate or legal entity.
(2) Dangerous drugs received by the state or a local government
entity from a department or agency of the federal government or an
agent of the federal government specifically authorized to deliver
dangerous drugs to the state or local government entity.
(3) The provision of samples of dangerous drugs by a manufacturer'
s employee to an authorized prescriber, provided the samples are
dispensed to a patient of the prescriber without charge.
(4) (A) A sale, trade, or transfer of a radioactive drug, as
defined in Section 1708.3 of Title 16 of the California Code of
Regulations, between any two entities licensed by the Radiologic
Health Branch of the State Department of Public Health, the federal
Nuclear Regulatory Commission, or an Agreement state.
(B) The exemption in this paragraph shall remain in effect unless
the board, no earlier than the date that is two years after the
compliance date for manufacturers set forth in subdivision (k) of
Section 4034 or Section 4163.5, determines after consultation with
the Radiologic Health Branch of the State Department of Public Health
that the risk of counterfeiting or diversion of a radioactive drug
is sufficient to require a pedigree. Two years following the date of
any such determination, this paragraph shall become inoperative.
(5) The sale, trade, or transfer of a dangerous drug that is
labeled by the manufacturer as "for veterinary use only."
(6) The sale, trade, or transfer of compressed medical gas. For
purposes of this section, "compressed medical gas" means any
substance in its gaseous or cryogenic liquid form that meets medical
purity standards and has application in a medical or homecare
environment, including, but not limited to, oxygen and nitrous oxide.
(7) The sale, trade, or transfer of solutions. For purposes of
this section, "solutions" means any of the following:
(A) Those intravenous products that, by their formulation, are
intended for the replenishment of fluids and electrolytes, such as
sodium, chloride, and potassium, calories, such as dextrose and amino
acids, or both.
(B) Those intravenous products used to maintain the equilibrium of
water and minerals in the body, such as dialysis solutions.
(C) Products that are intended for irrigation or reconstitution,
as well as sterile water, whether intended for those purposes or for
injection.
(8) Dangerous drugs that are placed in a sealed package with a
medical device or medical supplies at the point of first shipment
into commerce by the manufacturer and the package remains sealed
until the drug and device are used, provided that the package is only
used for surgical purposes.
(9) A product that meets either of the following criteria:
(A) A product comprised of two or more regulated components, such
as a drug/device, biologic/device, or drug/device/biologic, that are
physically, chemically, or otherwise combined or mixed and produced
as a single entity.
(B) Two or more separate products packaged together in a single
package or as a unit and comprised of drug and device products or
device and biological products.
(h) If a manufacturer, wholesaler, or pharmacy has reasonable
cause to believe that a dangerous drug in, or having been in, its
possession is counterfeit or the subject of a fraudulent transaction,
the manufacturer, wholesaler, or pharmacy shall notify the board
within 72 hours of obtaining that knowledge. This subdivision shall
apply to any dangerous drug that has been sold or distributed in or
through this state.
(i) "Interoperable electronic system" as used in this chapter
means an electronic track and trace system for dangerous drugs that
uses a unique identification number, established at the point of
manufacture and supplemented by a linked unique identification number
in the event that drug is repackaged, contained within a
standardized nonproprietary data format and architecture, that is
uniformly used by manufacturers, wholesalers, repackagers, and
pharmacies for the pedigree of a dangerous drug. No particular data
carrier or other technology is mandated to accomplish the attachment
of the unique identification number described in this subdivision.
(j) The application of the pedigree requirement shall be subject
to review during the board's evaluation pursuant to Section 473.4.
(k) This section shall become operative on January 1, 2015.
4034.1. (a) (1) Upon the effective date of federal legislation or
adoption of a federal regulation addressing pedigree or serialization
measures for dangerous drugs, Sections 4034, 4163, 4163.1, 4163.2,
4163.4, and 4163.5 shall become inoperative.
(2) Within 90 days of the enactment of federal legislation or
adoption of a regulation addressing pedigree or serialization
measures for dangerous drugs, the board shall publish a notice that
Sections 4034, 4163, 4163.1, 4163.2, 4163.4, and 4163.5 are
inoperative.
(3) Within 90 days of the enactment of federal legislation or
adoption of a regulation that is inconsistent with any provision of
California law governing the application of any pedigree or
serialization requirement or standard, the board shall adopt
emergency regulations necessary to reflect the inoperation of state
law.
(b) (1) If the Food and Drug Administration (FDA) enacts any rule,
standard, or takes any other action that is inconsistent with any
provision of California law governing application of a pedigree to a
dangerous drug, that provision of California law shall be
inoperative.
(2) Within 90 days of the FDA enacting any rule, standard, or
taking any other action that is inconsistent with any provision of
California law governing application of a pedigree to a dangerous
drug, the board shall publish a notice that the provision is
inoperative.
(3) Within 90 days of the FDA enacting any rule, standard, or
taking any other action that is inconsistent with any provision of
California law governing application of a pedigree to a dangerous
drug, the board shall adopt emergency regulations necessary to
reflect the inoperation of state law.
(c) If the board fails to recognize the inoperation within 90 days
pursuant to this section, nothing in this section shall preclude a
party from filing an action in state or federal court for declaratory
or injunctive relief as an alternative to filing a petition with the
board.
4035. "Person" includes firm, association, partnership,
corporation, limited liability company, state governmental agency, or
political subdivision.
4036. "Pharmacist" means a natural person to whom a license has
been issued by the board, under Section 4200, except as specifically
provided otherwise in this chapter. The holder of an unexpired and
active pharmacist license issued by the board is entitled to practice
pharmacy as defined by this chapter, within or outside of a licensed
pharmacy as authorized by this chapter.
4036.5. "Pharmacist-in-charge" means a pharmacist proposed by a
pharmacy and approved by the board as the supervisor or manager
responsible for ensuring the pharmacy's compliance with all state and
federal laws and regulations pertaining to the practice of pharmacy.
4037. (a) "Pharmacy" means an area, place, or premises licensed by
the board in which the profession of pharmacy is practiced and where
prescriptions are compounded. "Pharmacy" includes, but is not limited
to, any area, place, or premises described in a license issued by
the board wherein controlled substances, dangerous drugs, or
dangerous devices are stored, possessed, prepared, manufactured,
derived, compounded, or repackaged, and from which the controlled
substances, dangerous drugs, or dangerous devices are furnished,
sold, or dispensed at retail.
(b) "Pharmacy" shall not include any area in a facility licensed
by the State Department of Public Health where floor supplies, ward
supplies, operating room supplies, or emergency room supplies of
dangerous drugs or dangerous devices are stored or possessed solely
for treatment of patients registered for treatment in the facility or
for treatment of patients receiving emergency care in the facility.
4038. (a) "Pharmacy technician" means an individual who assists a
pharmacist in a pharmacy in the performance of his or her pharmacy
related duties, as specified in Section 4115.
(b) A "pharmacy technician trainee" is a person who is enrolled in
a pharmacy technician training program operated by a California
public postsecondary education institution or by a private
postsecondary vocational institution approved by the Bureau for
Private Postsecondary and Vocational Education.
4039. "Physicians," "dentists," "optometrists," "pharmacists,"
"podiatrists," "veterinarians," "veterinary surgeons," "registered
nurses," "naturopathic doctors," and "physician's assistants" are
persons authorized by a currently valid and unrevoked license to
practice their respective professions in this state. "Physician"
means and includes any person holding a valid and unrevoked physician'
s and surgeon's certificate or certificate to practice medicine and
surgery, issued by the Medical Board of California or the Osteopathic
Medical Board of California, and includes an unlicensed person
lawfully practicing medicine pursuant to Section 2065, when acting
within the scope of that section.
4040. (a) "Prescription" means an oral, written, or electronic
transmission order that is both of the following:
(1) Given individually for the person or persons for whom ordered
that includes all of the following:
(A) The name or names and address of the patient or patients.
(B) The name and quantity of the drug or device prescribed and the
directions for use.
(C) The date of issue.
(D) Either rubber stamped, typed, or printed by hand or typeset,
the name, address, and telephone number of the prescriber, his or her
license classification, and his or her federal registry number, if a
controlled substance is prescribed.
(E) A legible, clear notice of the condition or purpose for which
the drug is being prescribed, if requested by the patient or
patients.
(F) If in writing, signed by the prescriber issuing the order, or
the certified nurse-midwife, nurse practitioner, physician assistant,
or naturopathic doctor who issues a drug order pursuant to Section
2746.51, 2836.1, 3502.1, or 3640.5, respectively, or the pharmacist
who issues a drug order pursuant to either Section 4052.1 or 4052.2.
(2) Issued by a physician, dentist, optometrist, podiatrist,
veterinarian, or naturopathic doctor pursuant to Section 3640.7 or,
if a drug order is issued pursuant to Section 2746.51, 2836.1,
3502.1, or 3460.5, by a certified nurse-midwife, nurse practitioner,
physician assistant, or naturopathic doctor licensed in this state,
or pursuant to either Section 4052.1 or 4052.2 by a pharmacist
licensed in this state.
(b) Notwithstanding subdivision (a), a written order of the
prescriber for a dangerous drug, except for any Schedule II
controlled substance, that contains at least the name and signature
of the prescriber, the name and address of the patient in a manner
consistent with paragraph (2) of subdivision (a) of Section 11164 of
the Health and Safety Code, the name and quantity of the drug
prescribed, directions for use, and the date of issue may be treated
as a prescription by the dispensing pharmacist as long as any
additional information required by subdivision (a) is readily
retrievable in the pharmacy. In the event of a conflict between this
subdivision and Section 11164 of the Health and Safety Code, Section
11164 of the Health and Safety Code shall prevail.
(c) "Electronic transmission prescription" includes both image and
data prescriptions. "Electronic image transmission prescription"
means any prescription order for which a facsimile of the order is
received by a pharmacy from a licensed prescriber. "Electronic data
transmission prescription" means any prescription order, other than
an electronic image transmission prescription, that is electronically
transmitted from a licensed prescriber to a pharmacy.
(d) The use of commonly used abbreviations shall not invalidate an
otherwise valid prescription.
(e) Nothing in the amendments made to this section (formerly
Section 4036) at the 1969 Regular Session of the Legislature shall be
construed as expanding or limiting the right that a chiropractor,
while acting within the scope of his or her license, may have to
prescribe a device.
4040.5. "Reverse distributor" means every person who acts as an
agent for pharmacies, drug wholesalers, manufacturers, and other
entities by receiving, inventorying, and managing the disposition of
outdated or nonsalable dangerous drugs.
4041. "Veterinary food-animal drug retailer" is an area, place, or
premises, other than a pharmacy, that holds a valid license from the
Board of Pharmacy of the State of California as a wholesaler and, in
and from which veterinary drugs for food-producing animals are
dispensed pursuant to a prescription from a licensed veterinarian.
"Veterinary food-animal retailer" includes, but is not limited to,
any area, place, or premises described in a permit issued by the
board wherein veterinary food-animal drugs, as defined in Section
4042, are stored, possessed, or repackaged, and from which veterinary
drugs are furnished, sold, or dispensed at retail pursuant to a
prescription from a licensed veterinarian.
4042. "Veterinary food-animal drugs" as used in this chapter shall
include the following:
(a) Any drug to be used in food-producing animals bearing the
legend, "Caution, federal law restricts this drug to use by or on the
order of a licensed veterinarian" or words of similar import.
(b) Any other drug as defined in Section 14206 of the Food and
Agricultural Code that is used in a manner that would require a
veterinary prescription.
4043. (a) "Wholesaler" means and includes a person who acts as a
wholesale merchant, broker, jobber, customs broker, reverse
distributor, agent, or a nonresident wholesaler, who sells for
resale, or negotiates for distribution, or takes possession of, any
drug or device included in Section 4022. Unless otherwise authorized
by law, a wholesaler may not store, warehouse, or authorize the
storage or warehousing of drugs with any person or at any location
not licensed by the board.
(b) This section shall become operative January 1, 2006.
4044. "Repackager" means a person or entity that is registered with
the federal Food and Drug Administration as a repackager and
operates an establishment that packages finished drugs from bulk or
that repackages dangerous drugs into different containers, excluding
shipping containers.
4045. "Third-party logistics provider" or "reverse third-party
logistic provider" means an entity licensed as a wholesaler that
contracts with a dangerous drug manufacturer to provide or coordinate
warehousing, distribution, or other similar services on behalf of a
manufacturer, but for which there is no change of ownership in the
dangerous drugs. For purposes of Sections 4034, 4163, 4163.1, 4163.2,
4163.3, 4163.4, and 4163.5, a third-party logistics provider shall
not be responsible for generating or updating pedigree documentation,
but shall maintain copies of the pedigree. To be exempt from
documentation for pedigrees, a reverse third-party logistic provider
may only accept decommissioned drugs from pharmacies or wholesalers.
4015. For purposes of this chapter, the definitions of the terms in
this article shall govern the construction of this chapter, unless
otherwise indicated.
4016. "Administer" means the direct application of a drug or device
to the body of a patient or research subject by injection,
inhalation, ingestion, or other means.
4017. "Authorized officers of the law" means inspectors of the
California State Board of Pharmacy, inspectors of the Food and Drug
Branch of the State Department of Public Health, and investigators of
the department's Division of Investigation or peace officers engaged
in official investigations.
4018. "Board" means the California State Board of Pharmacy.
4019. An "order," entered on the chart or medical record of a
patient registered in a hospital or a patient under emergency
treatment in the hospital, by or on the order of a practitioner
authorized by law to prescribe drugs, shall be authorization for the
administration of the drug from hospital floor or ward stocks
furnished by the hospital pharmacy or under licensure granted under
Section 4056, and shall be considered to be a prescription if the
medication is to be furnished directly to the patient by the hospital
pharmacy or another pharmacy furnishing prescribed drugs for
hospital patients; provided that the chart or medical record of the
patient contains all of the information required by Sections 4040 and
4070 and the order is signed by the practitioner authorized by law
to prescribe drugs, if he or she is present when the drugs are given.
If he or she is not present when the drugs are given, the order
shall be signed either by the attending physician responsible for the
patient's care at the time the drugs are given to the patient or by
the practitioner who ordered the drugs for the patient on the
practitioner's next visit to the hospital.
4021. "Controlled substance" means any substance listed in Chapter
2 (commencing with Section 11053) of Division 10 of the Health and
Safety Code.
4022. "Dangerous drug" or "dangerous device" means any drug or
device unsafe for self-use in humans or animals, and includes the
following:
(a) Any drug that bears the legend: "Caution: federal law
prohibits dispensing without prescription," "Rx only," or words of
similar import.
(b) Any device that bears the statement: "Caution: federal law
restricts this device to sale by or on the order of a ____," "Rx
only," or words of similar import, the blank to be filled in with the
designation of the practitioner licensed to use or order use of the
device.
(c) Any other drug or device that by federal or state law can be
lawfully dispensed only on prescription or furnished pursuant to
Section 4006.
4022.5. (a) "Designated representative" means an individual to whom
a license has been granted pursuant to Section 4053. A pharmacist
fulfilling the duties of Section 4053 shall not be required to obtain
a license as a designated representative.
(b) "Designated representative-in-charge" means a designated
representative or a pharmacist proposed by a wholesaler or veterinary
food-animal drug retailer and approved by the board as the
supervisor or manager responsible for ensuring the wholesaler's or
veterinary food-animal drug retailer's compliance with all state and
federal laws and regulations pertaining to practice in the applicable
license category.
4023. "Device" means any instrument, apparatus, machine, implant,
in vitro reagent, or contrivance, including its components, parts,
products, or the byproducts of a device, and accessories that are
used or intended for either of the following:
(a) Use in the diagnosis, cure, mitigation, treatment, or
prevention of disease in a human or any other animal.
(b) To affect the structure or any function of the body of a human
or any other animal.
For purposes of this chapter, "device" does not include contact
lenses, or any prosthetic or orthopedic device that does not require
a prescription.
4023.5. For the purposes of this chapter, "direct supervision and
control" means that a pharmacist is on the premises at all times and
is fully aware of all activities performed by either a pharmacy
technician or intern pharmacist.
4024. (a) Except as provided in subdivision (b), "dispense" means
the furnishing of drugs or devices upon a prescription from a
physician, dentist, optometrist, podiatrist, veterinarian, or
naturopathic doctor pursuant to Section 3640.7, or upon an order to
furnish drugs or transmit a prescription from a certified
nurse-midwife, nurse practitioner, physician assistant, naturopathic
doctor pursuant to Section 3640.5, or pharmacist acting within the
scope of his or her practice.
(b) "Dispense" also means and refers to the furnishing of drugs or
devices directly to a patient by a physician, dentist, optometrist,
podiatrist, or veterinarian, or by a certified nurse-midwife, nurse
practitioner, naturopathic doctor, or physician assistant acting
within the scope of his or her practice.
4025. "Drug" means any of the following:
(a) Articles recognized in the official United States
Pharmacopoeia, official National Formulary or official Homeopathic
Pharmacopoeia of the United States, or any supplement of any of them.
(b) Articles intended for use in the diagnosis, cure, mitigation,
treatment, or prevention of disease in humans or other animals.
(c) Articles (other than food) intended to affect the structure or
any function of the body of humans or other animals.
(d) Articles intended for use as a component of any article
specified in subdivision (a), (b), or (c).
4025.1. "Nonprescription drug" means a drug which may be sold
without a prescription and which is labeled for use by the consumer
in accordance with the requirements of the laws and rules of this
state and the federal government.
4026. "Furnish" means to supply by any means, by sale or otherwise.
4026.5. "Good standing" means a license issued by the board that is
unrestricted by disciplinary action taken pursuant to Chapter 5
(commencing with Section 11500) of Part 1 of Division 3 of Title 2 of
the Government Code.
4027. (a) As used in this chapter, the terms "skilled nursing
facility," "intermediate care facility," and other references to
health facilities shall be construed with respect to the definitions
contained in Article 1 (commencing with Section 1250) of Chapter 2 of
Division 2 of the Health and Safety Code.
(b) As used in Section 4052.1, "licensed health care facility"
means a facility licensed pursuant to Article 1 (commencing with
Section 1250) of Chapter 2 of Division 2 of the Health and Safety
Code or a facility, as defined in Section 1250 of the Health and
Safety Code, operated by a health care service plan licensed pursuant
to Chapter 2.2 (commencing with Section 1340) of Division 2 of the
Health and Safety Code.
(c) As used in Section 4052.2, "health care facility" means a
facility, other than a facility licensed under Division 2 (commencing
with Section 1200) of the Health and Safety Code, that is owned or
operated by a health care service plan licensed pursuant to Chapter
2.2 (commencing with Section 1340) of the Health and Safety Code, or
by an organization under common ownership or control of the health
care service plan; "licensed home health agency" means a private or
public organization licensed by the State Department of Public Health
pursuant to Chapter 8 (commencing with Section 1725) of Division 2
of the Health and Safety Code, as further defined in Section 1727 of
the Health and Safety Code; and "licensed clinic" means a clinic
licensed pursuant to Article 1 (commencing with Section 1200) of
Chapter 1 of Division 2 of the Health and Safety Code.
(d) "Licensed health care facility" or "facility," as used in
Section 4065, means a health facility licensed pursuant to Article 1
(commencing with Section 1250) of Chapter 2 of Division 2 of the
Health and Safety Code or a facility that is owned or operated by a
health care service plan licensed pursuant to Chapter 2.2 (commencing
with Section 1340) of Division 2 of the Health and Safety Code or by
an organization under common ownership or control with the health
care service plan.
4028. "Licensed hospital" means an institution, place, building, or
agency that maintains and operates organized facilities for one or
more persons for the diagnosis, care, and treatment of human
illnesses to which persons may be admitted for overnight stay, and
includes any institution classified under regulations issued by the
State Department of Public Health as a general or specialized
hospital, as a maternity hospital, or as a tuberculosis hospital, but
does not include a sanitarium, rest home, a nursing or convalescent
home, a maternity home, or an institution for treating alcoholics.
4029. (a) "Hospital pharmacy" means and includes a pharmacy,
licensed by the board, located within any licensed hospital,
institution, or establishment that maintains and operates organized
facilities for the diagnosis, care, and treatment of human illnesses
to which persons may be admitted for overnight stay and that meets
all of the requirements of this chapter and the rules and regulations
of the board.
(b) A hospital pharmacy also includes a pharmacy that may be
located outside of the hospital, in another physical plant that is
regulated under a hospital's consolidated license issued pursuant to
Section 1250.8 of the Health and Safety Code. As a condition of
licensure by the board, the pharmacy in another physical plant shall
provide pharmaceutical services only to registered hospital patients
who are on the premises of the same physical plant in which the
pharmacy is located. The pharmacy services provided shall be directly
related to the services or treatment plan administered in the
physical plant. Nothing in this paragraph shall be construed to
restrict or expand the services that a hospital pharmacy may provide.
4030. "Intern pharmacist" means a person issued a license pursuant
to Section 4208.
4031. "Laboratory" means a research, teaching, or testing
laboratory not engaged in the dispensing or furnishing of drugs or
devices but using dangerous drugs or dangerous devices for scientific
or teaching purposes. Every laboratory shall maintain an established
place of business and keep purchase records. Every laboratory shall
be subject to the jurisdiction of the board.
4032. "License" means and includes any license, permit,
registration, certificate, or exemption issued by the board and
includes the process of applying for and renewing the same.
4033. (a) (1) "Manufacturer" means and includes every person who
prepares, derives, produces, compounds, or repackages any drug or
device except a pharmacy that manufactures on the immediate premises
where the drug or device is sold to the ultimate consumer.
(2) Notwithstanding paragraph (1), "manufacturer" shall not mean a
pharmacy compounding a drug for parenteral therapy, pursuant to a
prescription, for delivery to another pharmacy for the purpose of
delivering or administering the drug to the patient or patients named
in the prescription, provided that neither the components for the
drug nor the drug are compounded, fabricated, packaged, or otherwise
prepared prior to receipt of the prescription.
(3) Notwithstanding paragraph (1), "manufacturer" shall not mean a
pharmacy that, at a patient's request, repackages a drug previously
dispensed to the patient, or to the patient's agent, pursuant to a
prescription.
(b) Notwithstanding subdivision (a), as used in Sections 4034,
4163, 4163.1, 4163.2, 4163.3, 4163.4, and 4163.5, "manufacturer"
means a person who prepares, derives, manufactures, produces, or
repackages a dangerous drug, as defined in Section 4022, device, or
cosmetic. Manufacturer also means the holder or holders of a New Drug
Application (NDA), an Abbreviated New Drug Application (ANDA), or a
Biologics License Application (BLA), provided that such application
has been approved; a manufacturer's third party logistics provider; a
private label distributor (including colicensed partners) for whom
the private label distributor's prescription drugs are originally
manufactured and labeled for the distributor and have not been
repackaged; or the distributor agent for the manufacturer, contract
manufacturer, or private label distributor, whether the establishment
is a member of the manufacturer's affiliated group (regardless of
whether the member takes title to the drug) or is a contract
distributor site.
4034. (a) "Pedigree" means a record, in electronic form, containing
information regarding each transaction resulting in a change of
ownership of a given dangerous drug, from sale by a manufacturer,
through acquisition and sale by one or more wholesalers,
manufacturers, repackagers, or pharmacies, until final sale to a
pharmacy or other person furnishing, administering, or dispensing the
dangerous drug. The pedigree shall be created and maintained in an
interoperable electronic system, ensuring compatibility throughout
all stages of distribution.
(b) A pedigree shall include all of the following information:
(1) The source of the dangerous drug, including the name, the
federal manufacturer's registration number or a state license number
as determined by the board, and principal address of the source.
(2) The trade or generic name of the dangerous drug, the quantity
of the dangerous drug, its dosage form and strength, the date of the
transaction, the sales invoice number or, if not immediately
available, a customer-specific shipping reference number linked to
the sales invoice number, the container size, the number of
containers, the expiration dates, and the lot numbers.
(3) The business name, address, and the federal manufacturer's
registration number or a state license number as determined by the
board, of each owner of the dangerous drug, and the dangerous drug
shipping information, including the name and address of each person
certifying delivery or receipt of the dangerous drug.
(4) A certification under penalty of perjury from a responsible
party of the source of the dangerous drug that the information
contained in the pedigree is true and accurate.
(5) The unique identification number described in subdivision (i).
(c) A single pedigree shall include every change of ownership of a
given dangerous drug from its initial manufacture through to its
final transaction to a pharmacy or other person for furnishing,
administering, or dispensing the drug, regardless of repackaging or
assignment of another National Drug Code (NDC) Directory number.
Dangerous drugs that are repackaged shall be serialized by the
repackager and a pedigree shall be provided that references the
pedigree of the original package or packages provided by the
manufacturer.
(d) A pedigree shall track each dangerous drug at the smallest
package or immediate container distributed by the manufacturer,
received and distributed by the wholesaler or repackager, and
received by the pharmacy or another person furnishing, administering,
or dispensing the dangerous drug. For purposes of this section, the
"smallest package or immediate container" of a dangerous drug shall
include any dangerous drug package or container made available to a
repackager, wholesaler, pharmacy, or other entity for repackaging or
redistribution, as well as the smallest unit made by the manufacturer
for sale to the pharmacy or other person furnishing, administering,
or dispensing the drug.
(e) Any return of a dangerous drug to a wholesaler or manufacturer
shall be documented on the same pedigree as the transaction that
resulted in the receipt of the drug by the party returning it.
(f) If a licensed health care service plan, hospital organization,
and one or more physician organizations have exclusive contractual
relationships to provide health care services, drugs distributed
between these persons shall be deemed not to have changed ownership.
(g) The following transactions are exempt from the pedigree
requirement created by this section:
(1) An intracompany sale or transfer of a dangerous drug. For
purposes of this section, "intracompany sale or transfer" means any
transaction for any valid business purpose between a division,
subsidiary, parent, or affiliated or related company under the common
ownership and control of the same corporate or legal entity.
(2) Dangerous drugs received by the state or a local government
entity from a department or agency of the federal government or an
agent of the federal government specifically authorized to deliver
dangerous drugs to the state or local government entity.
(3) The provision of samples of dangerous drugs by a manufacturer'
s employee to an authorized prescriber, provided the samples are
dispensed to a patient of the prescriber without charge.
(4) (A) A sale, trade, or transfer of a radioactive drug, as
defined in Section 1708.3 of Title 16 of the California Code of
Regulations, between any two entities licensed by the Radiologic
Health Branch of the State Department of Public Health, the federal
Nuclear Regulatory Commission, or an Agreement state.
(B) The exemption in this paragraph shall remain in effect unless
the board, no earlier than the date that is two years after the
compliance date for manufacturers set forth in subdivision (k) of
Section 4034 or Section 4163.5, determines after consultation with
the Radiologic Health Branch of the State Department of Public Health
that the risk of counterfeiting or diversion of a radioactive drug
is sufficient to require a pedigree. Two years following the date of
any such determination, this paragraph shall become inoperative.
(5) The sale, trade, or transfer of a dangerous drug that is
labeled by the manufacturer as "for veterinary use only."
(6) The sale, trade, or transfer of compressed medical gas. For
purposes of this section, "compressed medical gas" means any
substance in its gaseous or cryogenic liquid form that meets medical
purity standards and has application in a medical or homecare
environment, including, but not limited to, oxygen and nitrous oxide.
(7) The sale, trade, or transfer of solutions. For purposes of
this section, "solutions" means any of the following:
(A) Those intravenous products that, by their formulation, are
intended for the replenishment of fluids and electrolytes, such as
sodium, chloride, and potassium, calories, such as dextrose and amino
acids, or both.
(B) Those intravenous products used to maintain the equilibrium of
water and minerals in the body, such as dialysis solutions.
(C) Products that are intended for irrigation or reconstitution,
as well as sterile water, whether intended for those purposes or for
injection.
(8) Dangerous drugs that are placed in a sealed package with a
medical device or medical supplies at the point of first shipment
into commerce by the manufacturer and the package remains sealed
until the drug and device are used, provided that the package is only
used for surgical purposes.
(9) A product that meets either of the following criteria:
(A) A product comprised of two or more regulated components, such
as a drug/device, biologic/device, or drug/device/biologic, that are
physically, chemically, or otherwise combined or mixed and produced
as a single entity.
(B) Two or more separate products packaged together in a single
package or as a unit and comprised of drug and device products or
device and biological products.
(h) If a manufacturer, wholesaler, or pharmacy has reasonable
cause to believe that a dangerous drug in, or having been in, its
possession is counterfeit or the subject of a fraudulent transaction,
the manufacturer, wholesaler, or pharmacy shall notify the board
within 72 hours of obtaining that knowledge. This subdivision shall
apply to any dangerous drug that has been sold or distributed in or
through this state.
(i) "Interoperable electronic system" as used in this chapter
means an electronic track and trace system for dangerous drugs that
uses a unique identification number, established at the point of
manufacture and supplemented by a linked unique identification number
in the event that drug is repackaged, contained within a
standardized nonproprietary data format and architecture, that is
uniformly used by manufacturers, wholesalers, repackagers, and
pharmacies for the pedigree of a dangerous drug. No particular data
carrier or other technology is mandated to accomplish the attachment
of the unique identification number described in this subdivision.
(j) The application of the pedigree requirement shall be subject
to review during the board's evaluation pursuant to Section 473.4.
(k) This section shall become operative on January 1, 2015.
4034.1. (a) (1) Upon the effective date of federal legislation or
adoption of a federal regulation addressing pedigree or serialization
measures for dangerous drugs, Sections 4034, 4163, 4163.1, 4163.2,
4163.4, and 4163.5 shall become inoperative.
(2) Within 90 days of the enactment of federal legislation or
adoption of a regulation addressing pedigree or serialization
measures for dangerous drugs, the board shall publish a notice that
Sections 4034, 4163, 4163.1, 4163.2, 4163.4, and 4163.5 are
inoperative.
(3) Within 90 days of the enactment of federal legislation or
adoption of a regulation that is inconsistent with any provision of
California law governing the application of any pedigree or
serialization requirement or standard, the board shall adopt
emergency regulations necessary to reflect the inoperation of state
law.
(b) (1) If the Food and Drug Administration (FDA) enacts any rule,
standard, or takes any other action that is inconsistent with any
provision of California law governing application of a pedigree to a
dangerous drug, that provision of California law shall be
inoperative.
(2) Within 90 days of the FDA enacting any rule, standard, or
taking any other action that is inconsistent with any provision of
California law governing application of a pedigree to a dangerous
drug, the board shall publish a notice that the provision is
inoperative.
(3) Within 90 days of the FDA enacting any rule, standard, or
taking any other action that is inconsistent with any provision of
California law governing application of a pedigree to a dangerous
drug, the board shall adopt emergency regulations necessary to
reflect the inoperation of state law.
(c) If the board fails to recognize the inoperation within 90 days
pursuant to this section, nothing in this section shall preclude a
party from filing an action in state or federal court for declaratory
or injunctive relief as an alternative to filing a petition with the
board.
4035. "Person" includes firm, association, partnership,
corporation, limited liability company, state governmental agency, or
political subdivision.
4036. "Pharmacist" means a natural person to whom a license has
been issued by the board, under Section 4200, except as specifically
provided otherwise in this chapter. The holder of an unexpired and
active pharmacist license issued by the board is entitled to practice
pharmacy as defined by this chapter, within or outside of a licensed
pharmacy as authorized by this chapter.
4036.5. "Pharmacist-in-charge" means a pharmacist proposed by a
pharmacy and approved by the board as the supervisor or manager
responsible for ensuring the pharmacy's compliance with all state and
federal laws and regulations pertaining to the practice of pharmacy.
4037. (a) "Pharmacy" means an area, place, or premises licensed by
the board in which the profession of pharmacy is practiced and where
prescriptions are compounded. "Pharmacy" includes, but is not limited
to, any area, place, or premises described in a license issued by
the board wherein controlled substances, dangerous drugs, or
dangerous devices are stored, possessed, prepared, manufactured,
derived, compounded, or repackaged, and from which the controlled
substances, dangerous drugs, or dangerous devices are furnished,
sold, or dispensed at retail.
(b) "Pharmacy" shall not include any area in a facility licensed
by the State Department of Public Health where floor supplies, ward
supplies, operating room supplies, or emergency room supplies of
dangerous drugs or dangerous devices are stored or possessed solely
for treatment of patients registered for treatment in the facility or
for treatment of patients receiving emergency care in the facility.
4038. (a) "Pharmacy technician" means an individual who assists a
pharmacist in a pharmacy in the performance of his or her pharmacy
related duties, as specified in Section 4115.
(b) A "pharmacy technician trainee" is a person who is enrolled in
a pharmacy technician training program operated by a California
public postsecondary education institution or by a private
postsecondary vocational institution approved by the Bureau for
Private Postsecondary and Vocational Education.
4039. "Physicians," "dentists," "optometrists," "pharmacists,"
"podiatrists," "veterinarians," "veterinary surgeons," "registered
nurses," "naturopathic doctors," and "physician's assistants" are
persons authorized by a currently valid and unrevoked license to
practice their respective professions in this state. "Physician"
means and includes any person holding a valid and unrevoked physician'
s and surgeon's certificate or certificate to practice medicine and
surgery, issued by the Medical Board of California or the Osteopathic
Medical Board of California, and includes an unlicensed person
lawfully practicing medicine pursuant to Section 2065, when acting
within the scope of that section.
4040. (a) "Prescription" means an oral, written, or electronic
transmission order that is both of the following:
(1) Given individually for the person or persons for whom ordered
that includes all of the following:
(A) The name or names and address of the patient or patients.
(B) The name and quantity of the drug or device prescribed and the
directions for use.
(C) The date of issue.
(D) Either rubber stamped, typed, or printed by hand or typeset,
the name, address, and telephone number of the prescriber, his or her
license classification, and his or her federal registry number, if a
controlled substance is prescribed.
(E) A legible, clear notice of the condition or purpose for which
the drug is being prescribed, if requested by the patient or
patients.
(F) If in writing, signed by the prescriber issuing the order, or
the certified nurse-midwife, nurse practitioner, physician assistant,
or naturopathic doctor who issues a drug order pursuant to Section
2746.51, 2836.1, 3502.1, or 3640.5, respectively, or the pharmacist
who issues a drug order pursuant to either Section 4052.1 or 4052.2.
(2) Issued by a physician, dentist, optometrist, podiatrist,
veterinarian, or naturopathic doctor pursuant to Section 3640.7 or,
if a drug order is issued pursuant to Section 2746.51, 2836.1,
3502.1, or 3460.5, by a certified nurse-midwife, nurse practitioner,
physician assistant, or naturopathic doctor licensed in this state,
or pursuant to either Section 4052.1 or 4052.2 by a pharmacist
licensed in this state.
(b) Notwithstanding subdivision (a), a written order of the
prescriber for a dangerous drug, except for any Schedule II
controlled substance, that contains at least the name and signature
of the prescriber, the name and address of the patient in a manner
consistent with paragraph (2) of subdivision (a) of Section 11164 of
the Health and Safety Code, the name and quantity of the drug
prescribed, directions for use, and the date of issue may be treated
as a prescription by the dispensing pharmacist as long as any
additional information required by subdivision (a) is readily
retrievable in the pharmacy. In the event of a conflict between this
subdivision and Section 11164 of the Health and Safety Code, Section
11164 of the Health and Safety Code shall prevail.
(c) "Electronic transmission prescription" includes both image and
data prescriptions. "Electronic image transmission prescription"
means any prescription order for which a facsimile of the order is
received by a pharmacy from a licensed prescriber. "Electronic data
transmission prescription" means any prescription order, other than
an electronic image transmission prescription, that is electronically
transmitted from a licensed prescriber to a pharmacy.
(d) The use of commonly used abbreviations shall not invalidate an
otherwise valid prescription.
(e) Nothing in the amendments made to this section (formerly
Section 4036) at the 1969 Regular Session of the Legislature shall be
construed as expanding or limiting the right that a chiropractor,
while acting within the scope of his or her license, may have to
prescribe a device.
4040.5. "Reverse distributor" means every person who acts as an
agent for pharmacies, drug wholesalers, manufacturers, and other
entities by receiving, inventorying, and managing the disposition of
outdated or nonsalable dangerous drugs.
4041. "Veterinary food-animal drug retailer" is an area, place, or
premises, other than a pharmacy, that holds a valid license from the
Board of Pharmacy of the State of California as a wholesaler and, in
and from which veterinary drugs for food-producing animals are
dispensed pursuant to a prescription from a licensed veterinarian.
"Veterinary food-animal retailer" includes, but is not limited to,
any area, place, or premises described in a permit issued by the
board wherein veterinary food-animal drugs, as defined in Section
4042, are stored, possessed, or repackaged, and from which veterinary
drugs are furnished, sold, or dispensed at retail pursuant to a
prescription from a licensed veterinarian.
4042. "Veterinary food-animal drugs" as used in this chapter shall
include the following:
(a) Any drug to be used in food-producing animals bearing the
legend, "Caution, federal law restricts this drug to use by or on the
order of a licensed veterinarian" or words of similar import.
(b) Any other drug as defined in Section 14206 of the Food and
Agricultural Code that is used in a manner that would require a
veterinary prescription.
4043. (a) "Wholesaler" means and includes a person who acts as a
wholesale merchant, broker, jobber, customs broker, reverse
distributor, agent, or a nonresident wholesaler, who sells for
resale, or negotiates for distribution, or takes possession of, any
drug or device included in Section 4022. Unless otherwise authorized
by law, a wholesaler may not store, warehouse, or authorize the
storage or warehousing of drugs with any person or at any location
not licensed by the board.
(b) This section shall become operative January 1, 2006.
4044. "Repackager" means a person or entity that is registered with
the federal Food and Drug Administration as a repackager and
operates an establishment that packages finished drugs from bulk or
that repackages dangerous drugs into different containers, excluding
shipping containers.
4045. "Third-party logistics provider" or "reverse third-party
logistic provider" means an entity licensed as a wholesaler that
contracts with a dangerous drug manufacturer to provide or coordinate
warehousing, distribution, or other similar services on behalf of a
manufacturer, but for which there is no change of ownership in the
dangerous drugs. For purposes of Sections 4034, 4163, 4163.1, 4163.2,
4163.3, 4163.4, and 4163.5, a third-party logistics provider shall
not be responsible for generating or updating pedigree documentation,
but shall maintain copies of the pedigree. To be exempt from
documentation for pedigrees, a reverse third-party logistic provider
may only accept decommissioned drugs from pharmacies or wholesalers.
