Kan. Admin. Regs. § 28-21-267 - Registration and renewal of registration
(a) Any
pharmaceutical firm desiring to manufacture amygdalin (laetrile) in the state
of Kansas shall file an application for a permit with the secretary of health
and environment. Such application shall be accompanied by a fee of $2,500 (two
thousand five hundred dollars) for the purpose of paying for the costs involved
in administering this program. The permit shall be effective for one (1) year
after the date of its issuance and may be renewed annually by the permit holder
for a fee of $1,000 (one thousand dollars). No permits or renewal of permits
shall be issued unless such fees have been collected. In addition to the permit
fee the manufacturer shall be responsible for all costs incurred by the state
department of health and environment for laboratory analysis and testing of
each lot number of amygdalin (laetrile) submitted to the department for its
approval and certification by the secretary of health and environment.
(b) The secretary of health and
environment, after giving notice and holding a hearing, may revoke, suspend, or
refuse to renew the permit of any person who violates any rule or regulation
adopted by the secretary of health and environment or who is subject to
applicable civil or criminal sanctions under the federal food, drug, and
cosmetic act.
(c) No person, other
than a physician, may sell, offer for sale, distribute, or dispense to the
public within this state amygdalin (laetrile) unless said person is currently
licensed to dispense by the Kansas board of pharmacy and first obtains a permit
from the secretary of health and environment authorizing the permit holder to
sell, offer for sale, distribute, or dispense amygdalin (laetrile) to the
public. Selling, offering for sale, or distributing amygdalin (laetrile) to the
public without a valid prescription of a physician to do so shall constitute a
class B misdemeanor.
(d)
Application for a permit to sell, offer for sale, or dispense amygdalin
(laetrile) to the public must be filed with the secretary of health and
environment and shall be accompanied by a fee of $10 (ten dollars) for the
purpose of paying for the costs in administering this program. The permit shall
be effective for one (1) year after the date of its issuance and may be renewed
annually by the permit holder for a fee of $10 (ten dollars). No permits or
renewal of permits shall be issued unless such fees have been collected.
(e) Any person who sells,
dispenses, or administers amygdalin (laetrile) to the public shall maintain
complete records of same on forms provided by the secretary of health and
environment.
Notes
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