South Carolina General Assembly
120th
Session, 2013-2014
H. 3444
STATUS INFORMATION
General
Bill
Sponsors:
Reps. Sandifer and Spires
Document
Path: l:\council\bills\agm\19858ab13.docx
Introduced
in the House on January 29, 2013
Last
Amended on April 10, 2013
Currently
residing in the Senate
Summary:
Out-of-state pharmacies
HISTORY OF LEGISLATIVE ACTIONS
Date Body Action Description with journal page number
1/29/2013 House Referred to Committee on Medical, Military, Public and Municipal Affairs (House Journal‑page 32)
3/21/2013 House Committee report: Favorable with amendment Medical, Military, Public and Municipal
Affairs (House Journal‑page 2)
3/22/2013 Scrivener's
error corrected
4/11/2013 House Read third time and sent to Senate
View
the latest legislative
information at the LPITS web site
VERSIONS OF THIS BILL
Indicates New Matter
AMENDED
April 10, 2013
H. 3444
Introduced by Reps.
Sandifer and Spires
S. Printed 4/10/13--H.
Read the first time January 29, 2013.
TO AMEND SECTION 40‑43‑83, CODE OF LAWS OF SOUTH CAROLINA,
1976, RELATING TO IN‑STATE FACILITIES DEALING WITH PRESCRIPTION DRUGS IN A
CERTAIN CAPACITY, SO AS TO APPLY NOTICE PROVISIONS TO OUT‑OF‑STATE FACILITIES
THAT SIMILARLY DEAL WITH PRESCRIPTION DRUGS, TO PROVIDE ALL SUCH FACILITIES
PERMITTED IN THIS STATE MUST PROVIDE NOTICE OF DISCIPLINARY ACTION TO THE
PHARMACY BOARD, TO PROVIDE AN OUT‑OF‑STATE FACILITY MUST PAY SPECIFIC EXPENSES
CONCERNING AN INSPECTION OF ITS FACILITIES BY THE BOARD, AND TO PROVIDE THE
BOARD MAY CONTRACT WITH A THIRD‑PARTY TO INSPECT FACILITIES OF A LICENSEE; AND
TO AMEND SECTION 40‑43‑89, RELATING TO WHOLESALE DISTRIBUTOR PERMITS, SO AS TO
REQUIRE A SURETY BOND OR LETTER OF CREDIT, TO REQUIRE A CRIMINAL BACKGROUND
CHECK OF THE APPLICANT, TO PROVIDE REQUIREMENTS FOR THE CERTIFICATION AND
CONDUCT OF A DESIGNATED REPRESENTATIVE OF A WHOLESALE DISTRIBUTOR.
Be
it enacted by the General Assembly of the State of South Carolina:
SECTION 1. Section
40‑43‑83 of the 1976 Code is amended to read:
“Section 40‑43‑83. (A) All facilities, whether
located within in this State or outside of this State,
engaging in the manufacture, production, sale, distribution, possession, or
dispensing of prescription drugs or devices and all facilities located outside
of this State whose primary business is mail order pharmacy service engaging in
the sale, distribution, or dispensing of prescription drugs or devices in this
State must be permitted by the Board of Pharmacy, and annually shall renew the
permit by June first. Where operations
are conducted at more than one location, each location must be permitted by the
Board of Pharmacy.
This subsection does not apply to a college
or university athletic department that dispenses prescription drugs or devices.
(B) Each
permittee located outside of this State who ships, mails, distributes, or
delivers prescription drugs or devices in this State and every pharmacy located
outside of this State who ships, mails, distributes, or delivers prescription
drugs or devices in this State shall designate a registered agent in this State
for service of process. Any such permittee
or pharmacy who does not so designate a registered agent is deemed to have
designated the Secretary of State of this State to be its true and lawful
attorney, upon whom may be served all legal process in any action or proceeding
against such permittee growing out of or arising from such delivery. A copy of any such service of process shall
be mailed to such permittee or pharmacy by the board by certified mail, return
receipt requested, postage prepaid, at the address such permittee has
designated on its application for licensure in this State. If any such person is not permitted in this
State, service on the Secretary of State only is sufficient service.
(C) The board shall determine and promulgate the
permit classifications of all
permits by regulation under this
chapter and establish minimum
standards for such permits.
(D) Each
pharmacy shall have a pharmacist‑in‑charge;
however, a college or university athletic department pharmacy is not
required to have a pharmacist‑in‑charge.
Whenever an applicable rule requires or prohibits action by a pharmacy,
responsibility is that of the permit holder and the pharmacist‑in‑charge of the
pharmacy, whether the ownership is a sole proprietor, partnership, association,
corporation, or otherwise.
(E) The
board may enter into agreements with other states or with third parties for the
purpose of exchanging information concerning the permitting and inspection of
entities located in this jurisdiction and those located outside this State.
(F) Permits
issued under this section must be displayed in a conspicuous place in the
permitted facility for which it was issued in such a manner that will enable an
interested person to determine the name of the permittee, permit number, and
permit expiration date. The permits are
not transferable.
(G) This
section must not be construed as precluding any person from owning or being a
permit holder if all of the dispensing, compounding, and retailing of
prescription drugs in it are under the supervision and direction of a licensed
pharmacist.
(H) The
Board of Pharmacy may deny or refuse to renew a permit if it determines that
the granting or renewing of such permit would not be in the public
interest. If an application is refused,
the board shall notify the applicant in writing of its decision and the reasons
for its decision.
(I) A
permit is required for the sale, distribution, possession, or dispensing of
drugs bearing the legend ‘Caution:
Federal law prohibits dispensing without a prescription’ including, but
not limited to, pharmacies (institutional or community, public or private),
nursing homes, hospitals, convalescent homes, extended care facilities, family
planning clinics, public or private health clinics, infirmaries, wholesalers,
correctional institutions, industrial health clinics, mail order vendors, and
manufacturers within or outside this State.
(J) The
board shall assess a civil penalty in the amount of fifty dollars for failure
to display a permit as required by this section.
(K) The
Department of Health and Environmental Control is exempt from the provisions of
this section that require facilities distributing or dispensing prescription
drugs to be permitted by the Board of Pharmacy and from the provisions of this
section that require each pharmacy to have a pharmacist‑in‑charge; however, each health district in this State
must have a permit to distribute or dispense prescription drugs.
(L) All
facilities permitted by this State shall notify the board within ten days of
receipt of any order or decision by a regulatory agency imposing disciplinary
action on the facility. If the permit or registration in the state where the
facility is located is suspended or revoked, then the facility’s registration
in South Carolina must be immediately suspended or revoked for the same period
of time. Failure to notify the board within ten days will result in suspension
pending board action.
(M) The
board shall require initial inspections and periodic inspections biennially
thereafter for permitting or permit renewal.
(N)(1) A facility located outside of the State but permitted in this
State shall pay the following fees for new and renewed permits, licenses,
registrations, and certifications:
(a) nonresident pharmacy initial permit ‑ five hundred and fifty
dollars, permit renewal ‑ four hundred and fifty dollars;
(b) nonresident wholesale distributor initial permit ‑ seven
hundred and fifty dollars, permit renewal ‑ seven hundred and fifty dollars;
(c) nonresident medical gases or legend devices drug outlet initial
permit ‑ four hundred dollars, permit renewal ‑ three hundred dollars.
(2) Fees collected pursuant to this subsection from nonresident
permit holders must be used exclusively to offset costs incurred by the board
for nonresident facility permitting and inspection activities.
(3) Nothing in this section may preclude the board from relying on
an inspection of the facility conducted by the regulatory authority of the
state within which the facility is located if the board has entered into a
Memorandum of Understanding (MOU) with that state.
(O) The
board may contract with a third party to undertake the inspection of the
facilities of a person who seeks an initial permit or permit renewal if the
third party maintains a program that has standards that are acceptable to the
board that the facility must meet for accreditation or certification by the
third party. The board may rely on this accreditation or certification in
determining eligibility for an initial permit or permit renewal.”
SECTION 2. Section
40‑43‑89(A) of the 1976 Code is amended to read:
“(A)(1) The
following information must be provided to the board with an application for a
wholesale distributor permit, and for any subsequent permit renewals:
(a) name,
full business address, and telephone number of the applicant;
(b) all
trade or business names used by the applicant;
(c) addresses,
telephone numbers, and the names of contact persons for the facility used by
the applicant for storage, handling, and distribution of drugs;
(d) the
type of ownership or operation, i.e., partnership, corporation, or sole
proprietorship; and
(e) evidence of a minimum one hundred thousand dollars surety bond
or certified letter of credit; and
(ef) name of the owner and/or,
operator, and designated representative of the applicant, including:
(i) if a person, the name, address, and
social security number or date of birth, or both, of the person;
(ii) if a partnership, the name, address, and social security number or
date of birth, or both, of each partner, and the name of the partnership;
(iii) if a corporation, the name, address, social security number or date
of birth, or both, and title of each corporate officer and director, the corporate
names, the name of the state of incorporation, and the name of the parent
company, if any; the name, address, and
social security number of each shareholder owning ten percent or more of the
voting stock of the corporation, including over‑the‑counter stock, unless the
stock is traded on a major stock exchange and not over‑the‑counter;
(iv) if a sole proprietorship, the full name, address, and social
security number or date of birth, or both, of the sole proprietor and the name
of the business entity.
(2) To be certified as a designated representative a person must:
(a) submit an application on a form furnished by the board and
provide information that includes, but is not limited to:
(i) information required to complete the criminal background
checks;
(ii) date and place of birth;
(iii) occupations, positions of employment, and
offices held during the past seven years;
(iv) principal business and address of any business corporation, or
other organization in which the applicant held an occupation, position of
employment, or office during the past seven years;
(v) whether the applicant, during the past seven years, has been
enjoined, either temporarily or permanently, by a court of competent
jurisdiction from violating any federal or state law regulating the possession,
control, or wholesale distribution of prescription drugs or devices, together
with details of the event;
(vi) description of any involvement by the applicant during the past
seven years with any business, including any investments, other than the
ownership of stock in a publicly traded company or mutual fund that
manufactured, administered, prescribed, wholesale distributed, or stored
prescription drugs and devices in which the business was named as a party in a
lawsuit;
(vii) description of any criminal offense,
excluding minor traffic violations, of which the applicant as an adult was
found guilty, regardless of whether adjudication of guilt was withheld or
whether he pled guilty or nolo contendere. If the applicant indicates that a
criminal conviction is under appeal and submits a copy of the notice of appeal
of the criminal offense, he must submit to the board a copy of the final
written order of disposition within fifteen days after the disposition of the
appeal;
(viii) photograph of the applicant taken within
the previous thirty days under procedures as specified by the board; and
(ix) any other information the board considers relevant.
(b) The designated representative certification must be renewed
every five years.
(3) A designated representative must have a minimum of two years of
verifiable full‑time managerial or supervisory experience in a pharmacy or
wholesale distributor permitted or registered in this State or another state,
where his responsibilities included but were not limited to record keeping,
storage, and shipment of prescription drugs or devices.
(4) A person may serve as the designated representative for only
one wholesale distributor at a time, except where more than one permitted or
registered wholesale distributor is colocated in the same facility and the
wholesale distributors are members of an affiliated group, as defined in
Section 1504 of the Internal Revenue Code.
(5) A designated representative must be actively involved in and
aware of the actual daily operations of the wholesale distributor and must meet
the following requirements:
(a) be employed full‑time in a managerial
position by the wholesale distributor;
(b) be physically present at the wholesale distributor during
normal business hours, except for time periods when absent due to illness,
family illness or death, scheduled vacation, or other authorized absence; and
(c) be aware of, and knowledgeable about, all policies and
procedures pertaining to the operations of a wholesale distributor.
(6) A designated representative must complete:
(a) continuing education programs specified by the board regarding
federal and state laws in regard to the wholesale distribution, handling, and
storage of prescription drugs or devices; or
(b) if no formal continuing education is specified by the board,
then board‑approved training programs that address applicable federal and state
laws and are provided by qualified in‑house specialists, outside counsel, or
consulting specialists with capabilities to help ensure compliance.
(7) The information collected pursuant to this section shall be
made available only to the board or its designee and to state and federal law
enforcement officials, if requested as part of an investigation. The board or
its designee shall ensure confidentiality of the information collected under
this section.
(8) A permitted or registered wholesale distributor located outside
of this State that conducts business in this State shall designate a registered
agent in this State for service of process or must be considered to have
designated the Secretary of State to be its true and lawful attorney, upon whom
may be served all legal processes in any action or proceeding against such permitted
or registered wholesale distributor growing out of or arising from such
wholesale distribution. The board must send by certified mail, return receipt
requested, postage prepaid, a copy of a service of process received by the
board to the wholesale distributor at the address the permitted or registered
wholesale distributor has designated on its application for a permit under this
chapter.
(29) Changes in any information in this subsection must be submitted to
the Board of Pharmacy within thirty days of the change.
(310) Pursuant to Section 40‑43‑83(E) and Section
40‑43‑90, the information required for initial permitting or renewal of a
permit of a wholesale distributor must be submitted on forms prepared by the
Board of Pharmacy or by the National Association of Boards of Pharmacy which
shall act as a clearinghouse of applications for the board and must be
submitted to the board or NABP accompanied by the applicable fee.
(411) The board may suspend, revoke, deny, or
refuse to renew the permit of wholesale drug distributors other than pharmacies
dispensing or distributing drugs or devices directly to patients.”
SECTION 3. This
act takes effect upon approval by the Governor.
‑‑‑‑XX‑‑‑‑
This Bill
www.scstatehouse.gov/sess120_2013-2014/bills/3444.docx
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