Reference is to the bill as introduced.
Amend the bill, as and if amended, by deleting all after the enacting words and inserting:
/ 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. /
Renumber sections to conform.
Amend title to conform.