Subchapter III. Regulation of Manufacture, Distribution and Dispensing of Controlled Substances
§ 4731. Rules; fees.
The Secretary may promulgate rules and charge reasonable fees relating to the registration and control of the manufacture,
distribution and dispensing of controlled substances within this State.
16 Del. C. 1953, § 4731; 58 Del. Laws, c. 424, § 1.;
(a) Any pharmacy, distributor, manufacturer, practitioner, researcher or under the classification of "Other Controlled Substance
Registrants," who has or proposes to engage in activities accordingly within this State must obtain biennially a registration
issued by the Secretary in accordance with the Secretary's rules.
(b) Any pharmacy, distributor, manufacturer, researcher or classified under "Other Controlled Substance Registrants" are limited
to those substances to the extent authorized by their registration and in conformity with the other provisions of this subchapter.
(c) The following persons need not register and may lawfully possess controlled substances under this chapter:
(1) An agent or employee of any registered manufacturer, distributor or dispenser of any controlled substance if the agent
or employee is acting in the usual course of the agent's or employee's business or employment;
(2) A common or contract carrier or warehouseperson, or an employee thereof, whose possession of any controlled substance
is in the usual course of business or employment; and
(3) An ultimate user or a person in possession of any controlled substance pursuant to a lawful order of a practitioner or
in lawful possession of a Schedule V substance.
(d) The Secretary may waive by rule the requirement for registration of certain manufacturers, distributors or dispensers
if the Secretary finds it consistent with the public health and safety.
(e) A separate registration is required at each principal place of business or professional practice where the applicant manufactures,
distributes, dispenses or conducts research with controlled substances. (Includes classification of "Other Controlled Substance
Registrants").
(f) The Secretary or the Secretary's representative may inspect the establishment of a registrant or applicant for registration
in accordance with the Secretary's rule.
(g) Every registrant under this chapter shall be required to report any change of professional or business address in such
a manner as the Secretary may require by regulation.
16 Del. C. 1953, § 4732; 58 Del. Laws, c. 424, § 1; 65 Del. Laws, c. 501, §§ 1, 2; 70 Del. Laws, c. 186, § 1; 71 Del. Laws, c. 288, § 7.;
§ 4733. Registration; rights of registrants.
(a) The Secretary shall register an applicant as a pharmacy, distributor, manufacturer, practitioner, research or under the
classification, "Other Controlled Substance Registrants" controlled substances included in §§ 4714, 4716, 4718, 4720 and 4722
unless the Secretary determines that the issuance of that registration would be inconsistent with the public interest. In
determining the public interest, the Secretary shall consider the following factors:
(1) Maintenance of effective controls against diversion of controlled substances into other than legitimate medical, scientific
or industrial channels;
(2) Compliance with applicable state and local law includes such requirements as having a license to practice as a practitioner
or having documented training and continuing education as a drug detection animal trainer;
(3) Any convictions of the applicant under any federal and state laws relating to any controlled substance;
(4) Past experience in the manufacture or distribution of controlled substances and the existence in the applicant's establishment
of effective controls against diversion;
(5) Furnishing by the applicant of false or fraudulent material in any application filed under this chapter;
(6) Suspension or revocation of the applicant's federal registration to manufacture, distribute, prescribe, dispense or research
controlled substances as authorized by federal law; and
(7) Any other factors relevant to and consistent with the public health and safety.
(b) Registration under subsection (a) does not entitle a registrant to manufacture, research and distribute controlled substances
including the classification of "Other Controlled Substance Registrants" in Schedule I or II other than those specified in
the registration.
(c) Practitioners must be registered to dispense any controlled substances or to conduct research with controlled substances
in Schedules II through V if they are authorized to dispense or conduct research under the law of this State. The Secretary
need not require separate registration under this subchapter for practitioners engaging in research with nonnarcotic controlled
substances in Schedules II through V where the registrant is already registered under this subchapter in another capacity.
Practitioners registered under federal law to conduct research with Schedule I substances may conduct research with Schedule
I substances within this State upon furnishing the Secretary evidence of that federal registration.
(d) Compliance by manufacturers and distributors with the federal law respecting registration (excluding fees) entitles them
to be registered under this chapter.
16 Del. C. 1953, § 4733; 58 Del. Laws, c. 424, § 1; 70 Del. Laws, c. 186, § 1; 71 Del. Laws, c. 288, § 8.;
§ 4734. Revocation and suspension of registration.
(a) A registration under § 4733 of this title as a pharmacy, distributor, manufacturer, practitioner, researcher or under
the classification of "Other Controlled Substance Registrants" may be suspended or revoked by the Secretary upon a finding
that continued registration would be inconsistent with the public interest. In determining the public interest, the Secretary
shall consider the following factors:
(1) Maintenance of effective controls against diversion of controlled substances into other than legitimate medical, scientific
or industrial channels;
(2) Compliance with applicable state and local law including such events as a practitioner losing their license to practice
or a drug detection animal trainer not obtaining or maintaining formal training and continuing education;
(3) Any convictions of the registrant under any federal and state laws relating to any controlled substance;
(4) The existence in the registrant's establishment of effective controls against diversion;
(5) Furnishing by the registrant of false or fraudulent material in any application filed under this chapter;
(6) Suspension or revocation of the registrant's federal registration to manufacture, distribute, prescribe, dispense or research
controlled substances as authorized by federal law; and
(7) Any other factors relevant to and consistent with the public health and safety.
(b) The Secretary may limit revocation or suspension of a registration to the particular controlled substance with respect
to which grounds for revocation or suspension exist.
(c) If the Secretary suspends or revokes a registration, all controlled substances owned or possessed by the registrant at
the time of suspension or the effective date of the revocation order may be placed under seal. No disposition may be made
of substances under seal until the time for taking an appeal has elapsed or until all appeals have been concluded unless a
court upon application therefor orders the sale of perishable substances and the deposit of the proceeds of the sale with
the court. Upon a revocation order becoming final, all controlled substances may be forfeited to the State.
(d) The Secretary shall promptly notify the Administration of all orders suspending or revoking registration and all forfeitures
of controlled substances.
16 Del. C. 1953, § 4734; 58 Del. Laws, c. 424, § 1; 60 Del. Laws, c. 583, § 4; 71 Del. Laws, c. 288, § 9.;
§ 4735. Order to show cause and subpoena; judicial review.
(a) Before denying, suspending or revoking a registration or refusing a renewal of registration, the Secretary shall serve
upon the applicant or registrant an order to show cause why registration should not be denied, revoked or suspended or why
the renewal should not be refused. The order to show cause shall contain a statement of the basis therefor and shall call
upon the applicant or registrant to appear before the Secretary at a time and place not less than 30 days after the date of
service of the order, but in the case of a denial or renewal of registration the show cause order shall be served not later
than 30 days before the expiration of the registration. These proceedings shall be conducted in accordance with the procedures
established by the Secretary without regard to any criminal prosecution or other proceeding. Proceedings to refuse renewal
of registration shall not abate the existing registration which shall remain in effect pending the outcome of the administrative
hearing.
(b) The Secretary may suspend, without an order to show cause, any registration simultaneously with the institution of proceedings
under § 4734 or where renewal of registration is refused, if the Secretary finds that there is an imminent danger to the public
health or safety which warrants this action. The suspension shall continue in effect until the conclusion of the proceedings,
including judicial review thereof, unless sooner withdrawn by the Secretary or dissolved by a court of competent jurisdiction.
(c) Any person complained against under this subchapter may appear personally or by counsel at the hearing and produce any
competent evidence in the person's behalf in answer to the alleged violation. The Secretary shall be authorized to administer
oaths, examine witnesses and issue, in the name of the Department of Health and Social Services, notices of hearings or subpoenas
requiring the testimony of witnesses and the production of books, records or other documents relevant to any matter involved
in such hearing, and subpoenas shall also be issued at the request of the applicant or person complained against. In case
of contumacy or refusal to obey a notice of hearing or subpoena under this section, the Superior Court in the county in which
the hearing is held shall have jurisdiction, upon application of the Secretary to issue an order requiring such person to
appear and testify or produce evidence as the case may require.
(d) Any party in interest aggrieved by a decision of the Secretary to deny, suspend, revoke or refuse to renew registration
under this subchapter may appeal such decision to Superior Court. Such appeal shall be on the record and the only question
before said Court shall be whether the Secretary abused the Secretary's discretion. When notified of an appeal under this
section, the Secretary shall forward to Superior Court a certified and complete copy of the written transcripts or taped voice
records of evidence adduced at the hearing before the Secretary together with a written copy of the Secretary's findings and
rulings and the Secretary's reasons therefor.
16 Del. C. 1953, § 4735; 58 Del. Laws, c. 424, § 1; 70 Del. Laws, c. 186, § 1.;
§ 4736. Authority of Secretary to impose fines.
(a) Whenever the Secretary has found a registrant to be guilty of a violation of this chapter or of rules adopted pursuant
to this chapter, the Secretary shall, in addition to the power and authority granted the Secretary in this chapter, have the
power to impose a fine on the registrant for such violation and require that such fine be paid, with the sanction that the
person's registration may be suspended until the fine is paid. No fine imposed by the Secretary may exceed $500.
(b) Prior to the imposition of any fine, the Secretary shall hold an investigation and hearing after notice to the registrant
or the registrant's attorney. A fine shall be imposed by the Secretary only upon finding that:
(1) The public welfare and morals would not be impaired by the imposition of such fine; and
(2) Payment of the sum of money will achieve the desired disciplinary purposes.
(c) The Secretary shall not impose a fine on a registrant whose registration has been revoked by the Secretary for such violation.
The power and authority of the Secretary to impose such fines is not to be affected by any other proceeding, civil or criminal,
concerning the same violation, nor shall the imposition of such fine preclude the Secretary from imposing other sanctions
short of revocation.
(d) Any person so fined may appeal to the Superior Court for a trial de novo, provided the appeal is taken within 15 days
of the time of the decision of the Secretary.
60 Del. Laws, c. 583, § 5; 70 Del. Laws, c. 186, § 1.;
§ 4737. Records of registrants.
Persons registered to manufacture, distribute or dispense controlled substances under this chapter shall keep records and
maintain inventories in conformance with the record-keeping and inventory requirements of federal law and with any additional
rules the Secretary issues.
16 Del. C. 1953, § 4736; 58 Del. Laws, c. 424, § 1; 60 Del. Laws, c. 583, § 5.;
§ 4738. Order forms.
Controlled substances in Schedules I and II shall be distributed by a registrant to another registrant only pursuant to an
order form. Compliance with federal law respecting order forms shall be deemed compliance with this section.
16 Del. C. 1953, § 4737; 58 Del. Laws, c. 424, § 1; 60 Del. Laws, c. 583, § 5.;
§ 4739. Prescriptions.
(a) Except when dispensed directly by a practitioner other than a pharmacy to an ultimate user, no controlled substance in
Schedule II may be dispensed without the written prescription of a practitioner.
(b) In emergency situations, as defined by rule of the Secretary, Schedule II drugs may be dispensed upon oral prescription
of a practitioner, reduced promptly to writing and filed by the pharmacy. Prescriptions shall be retained in conformity with
the requirements of § 4737. No prescription for a Schedule II substance may be refilled.
(c) Except when dispensed directly by a practitioner other than a pharmacy to an ultimate user, a controlled substance included
in Schedule III or IV which is a prescription drug shall not be dispensed without a written or oral prescription of a practitioner.
The prescription shall not be filled or refilled more than 6 months after the date thereof or be refilled more than 5 times,
unless renewed by the practitioner.
(d) A controlled substance included in Schedule V shall not be distributed or dispensed other than for a medical purpose.
16 Del. C. 1953, § 4738; 58 Del. Laws, c. 424, § 1; 60 Del. Laws, c. 583, § 5.;
§ 4740. Sale of pseudoephedrine or ephedrine.
(a) If any material, compound, mixture, or preparation containing any detectable quantity of pseudoephedrine or ephedrine,
its salts or optical isomers, or salts of optical isomers is dispensed, offered for sale, sold or distributed:
(1) It shall be dispensed, offered for sale, sold, or distributed only from behind a checkout counter, pharmacy counter, or
in a locked storage container where the public is not permitted.
(2) A licensed pharmacist, sales clerk, or pharmacy technician shall require that any person purchasing, receiving, or otherwise
acquiring any such substance shall be age 18 or older, produce a photo identification showing the date of birth of the person,
and sign a written log or receipt showing the date of the transaction, name of the person, and the amount of such substance.
The written log or receipt shall be retained for at least 12 months.
(3) No person, other than a pharmacy or retail establishment, shall purchase, receive, or otherwise acquire more than 9 grams
of any such substance within any 30-day period.
(b) A violation of this section is a class A misdemeanor.
75 Del. Laws, c. 52, § 1; 75 Del. Laws, c. 217, § 1; 77 Del. Laws, c. 334, § 1.;
Subchapter III. Regulation of Manufacture, Distribution and Dispensing of Controlled Substances
§ 4731. Rules; fees.
The Secretary may promulgate rules and charge reasonable fees relating to the registration and control of the manufacture,
distribution and dispensing of controlled substances within this State.
16 Del. C. 1953, § 4731; 58 Del. Laws, c. 424, § 1.;
(a) Any pharmacy, distributor, manufacturer, practitioner, researcher or under the classification of "Other Controlled Substance
Registrants," who has or proposes to engage in activities accordingly within this State must obtain biennially a registration
issued by the Secretary in accordance with the Secretary's rules.
(b) Any pharmacy, distributor, manufacturer, researcher or classified under "Other Controlled Substance Registrants" are limited
to those substances to the extent authorized by their registration and in conformity with the other provisions of this subchapter.
(c) The following persons need not register and may lawfully possess controlled substances under this chapter:
(1) An agent or employee of any registered manufacturer, distributor or dispenser of any controlled substance if the agent
or employee is acting in the usual course of the agent's or employee's business or employment;
(2) A common or contract carrier or warehouseperson, or an employee thereof, whose possession of any controlled substance
is in the usual course of business or employment; and
(3) An ultimate user or a person in possession of any controlled substance pursuant to a lawful order of a practitioner or
in lawful possession of a Schedule V substance.
(d) The Secretary may waive by rule the requirement for registration of certain manufacturers, distributors or dispensers
if the Secretary finds it consistent with the public health and safety.
(e) A separate registration is required at each principal place of business or professional practice where the applicant manufactures,
distributes, dispenses or conducts research with controlled substances. (Includes classification of "Other Controlled Substance
Registrants").
(f) The Secretary or the Secretary's representative may inspect the establishment of a registrant or applicant for registration
in accordance with the Secretary's rule.
(g) Every registrant under this chapter shall be required to report any change of professional or business address in such
a manner as the Secretary may require by regulation.
16 Del. C. 1953, § 4732; 58 Del. Laws, c. 424, § 1; 65 Del. Laws, c. 501, §§ 1, 2; 70 Del. Laws, c. 186, § 1; 71 Del. Laws, c. 288, § 7.;
§ 4733. Registration; rights of registrants.
(a) The Secretary shall register an applicant as a pharmacy, distributor, manufacturer, practitioner, research or under the
classification, "Other Controlled Substance Registrants" controlled substances included in §§ 4714, 4716, 4718, 4720 and 4722
unless the Secretary determines that the issuance of that registration would be inconsistent with the public interest. In
determining the public interest, the Secretary shall consider the following factors:
(1) Maintenance of effective controls against diversion of controlled substances into other than legitimate medical, scientific
or industrial channels;
(2) Compliance with applicable state and local law includes such requirements as having a license to practice as a practitioner
or having documented training and continuing education as a drug detection animal trainer;
(3) Any convictions of the applicant under any federal and state laws relating to any controlled substance;
(4) Past experience in the manufacture or distribution of controlled substances and the existence in the applicant's establishment
of effective controls against diversion;
(5) Furnishing by the applicant of false or fraudulent material in any application filed under this chapter;
(6) Suspension or revocation of the applicant's federal registration to manufacture, distribute, prescribe, dispense or research
controlled substances as authorized by federal law; and
(7) Any other factors relevant to and consistent with the public health and safety.
(b) Registration under subsection (a) does not entitle a registrant to manufacture, research and distribute controlled substances
including the classification of "Other Controlled Substance Registrants" in Schedule I or II other than those specified in
the registration.
(c) Practitioners must be registered to dispense any controlled substances or to conduct research with controlled substances
in Schedules II through V if they are authorized to dispense or conduct research under the law of this State. The Secretary
need not require separate registration under this subchapter for practitioners engaging in research with nonnarcotic controlled
substances in Schedules II through V where the registrant is already registered under this subchapter in another capacity.
Practitioners registered under federal law to conduct research with Schedule I substances may conduct research with Schedule
I substances within this State upon furnishing the Secretary evidence of that federal registration.
(d) Compliance by manufacturers and distributors with the federal law respecting registration (excluding fees) entitles them
to be registered under this chapter.
16 Del. C. 1953, § 4733; 58 Del. Laws, c. 424, § 1; 70 Del. Laws, c. 186, § 1; 71 Del. Laws, c. 288, § 8.;
§ 4734. Revocation and suspension of registration.
(a) A registration under § 4733 of this title as a pharmacy, distributor, manufacturer, practitioner, researcher or under
the classification of "Other Controlled Substance Registrants" may be suspended or revoked by the Secretary upon a finding
that continued registration would be inconsistent with the public interest. In determining the public interest, the Secretary
shall consider the following factors:
(1) Maintenance of effective controls against diversion of controlled substances into other than legitimate medical, scientific
or industrial channels;
(2) Compliance with applicable state and local law including such events as a practitioner losing their license to practice
or a drug detection animal trainer not obtaining or maintaining formal training and continuing education;
(3) Any convictions of the registrant under any federal and state laws relating to any controlled substance;
(4) The existence in the registrant's establishment of effective controls against diversion;
(5) Furnishing by the registrant of false or fraudulent material in any application filed under this chapter;
(6) Suspension or revocation of the registrant's federal registration to manufacture, distribute, prescribe, dispense or research
controlled substances as authorized by federal law; and
(7) Any other factors relevant to and consistent with the public health and safety.
(b) The Secretary may limit revocation or suspension of a registration to the particular controlled substance with respect
to which grounds for revocation or suspension exist.
(c) If the Secretary suspends or revokes a registration, all controlled substances owned or possessed by the registrant at
the time of suspension or the effective date of the revocation order may be placed under seal. No disposition may be made
of substances under seal until the time for taking an appeal has elapsed or until all appeals have been concluded unless a
court upon application therefor orders the sale of perishable substances and the deposit of the proceeds of the sale with
the court. Upon a revocation order becoming final, all controlled substances may be forfeited to the State.
(d) The Secretary shall promptly notify the Administration of all orders suspending or revoking registration and all forfeitures
of controlled substances.
16 Del. C. 1953, § 4734; 58 Del. Laws, c. 424, § 1; 60 Del. Laws, c. 583, § 4; 71 Del. Laws, c. 288, § 9.;
§ 4735. Order to show cause and subpoena; judicial review.
(a) Before denying, suspending or revoking a registration or refusing a renewal of registration, the Secretary shall serve
upon the applicant or registrant an order to show cause why registration should not be denied, revoked or suspended or why
the renewal should not be refused. The order to show cause shall contain a statement of the basis therefor and shall call
upon the applicant or registrant to appear before the Secretary at a time and place not less than 30 days after the date of
service of the order, but in the case of a denial or renewal of registration the show cause order shall be served not later
than 30 days before the expiration of the registration. These proceedings shall be conducted in accordance with the procedures
established by the Secretary without regard to any criminal prosecution or other proceeding. Proceedings to refuse renewal
of registration shall not abate the existing registration which shall remain in effect pending the outcome of the administrative
hearing.
(b) The Secretary may suspend, without an order to show cause, any registration simultaneously with the institution of proceedings
under § 4734 or where renewal of registration is refused, if the Secretary finds that there is an imminent danger to the public
health or safety which warrants this action. The suspension shall continue in effect until the conclusion of the proceedings,
including judicial review thereof, unless sooner withdrawn by the Secretary or dissolved by a court of competent jurisdiction.
(c) Any person complained against under this subchapter may appear personally or by counsel at the hearing and produce any
competent evidence in the person's behalf in answer to the alleged violation. The Secretary shall be authorized to administer
oaths, examine witnesses and issue, in the name of the Department of Health and Social Services, notices of hearings or subpoenas
requiring the testimony of witnesses and the production of books, records or other documents relevant to any matter involved
in such hearing, and subpoenas shall also be issued at the request of the applicant or person complained against. In case
of contumacy or refusal to obey a notice of hearing or subpoena under this section, the Superior Court in the county in which
the hearing is held shall have jurisdiction, upon application of the Secretary to issue an order requiring such person to
appear and testify or produce evidence as the case may require.
(d) Any party in interest aggrieved by a decision of the Secretary to deny, suspend, revoke or refuse to renew registration
under this subchapter may appeal such decision to Superior Court. Such appeal shall be on the record and the only question
before said Court shall be whether the Secretary abused the Secretary's discretion. When notified of an appeal under this
section, the Secretary shall forward to Superior Court a certified and complete copy of the written transcripts or taped voice
records of evidence adduced at the hearing before the Secretary together with a written copy of the Secretary's findings and
rulings and the Secretary's reasons therefor.
16 Del. C. 1953, § 4735; 58 Del. Laws, c. 424, § 1; 70 Del. Laws, c. 186, § 1.;
§ 4736. Authority of Secretary to impose fines.
(a) Whenever the Secretary has found a registrant to be guilty of a violation of this chapter or of rules adopted pursuant
to this chapter, the Secretary shall, in addition to the power and authority granted the Secretary in this chapter, have the
power to impose a fine on the registrant for such violation and require that such fine be paid, with the sanction that the
person's registration may be suspended until the fine is paid. No fine imposed by the Secretary may exceed $500.
(b) Prior to the imposition of any fine, the Secretary shall hold an investigation and hearing after notice to the registrant
or the registrant's attorney. A fine shall be imposed by the Secretary only upon finding that:
(1) The public welfare and morals would not be impaired by the imposition of such fine; and
(2) Payment of the sum of money will achieve the desired disciplinary purposes.
(c) The Secretary shall not impose a fine on a registrant whose registration has been revoked by the Secretary for such violation.
The power and authority of the Secretary to impose such fines is not to be affected by any other proceeding, civil or criminal,
concerning the same violation, nor shall the imposition of such fine preclude the Secretary from imposing other sanctions
short of revocation.
(d) Any person so fined may appeal to the Superior Court for a trial de novo, provided the appeal is taken within 15 days
of the time of the decision of the Secretary.
60 Del. Laws, c. 583, § 5; 70 Del. Laws, c. 186, § 1.;
§ 4737. Records of registrants.
Persons registered to manufacture, distribute or dispense controlled substances under this chapter shall keep records and
maintain inventories in conformance with the record-keeping and inventory requirements of federal law and with any additional
rules the Secretary issues.
16 Del. C. 1953, § 4736; 58 Del. Laws, c. 424, § 1; 60 Del. Laws, c. 583, § 5.;
§ 4738. Order forms.
Controlled substances in Schedules I and II shall be distributed by a registrant to another registrant only pursuant to an
order form. Compliance with federal law respecting order forms shall be deemed compliance with this section.
16 Del. C. 1953, § 4737; 58 Del. Laws, c. 424, § 1; 60 Del. Laws, c. 583, § 5.;
§ 4739. Prescriptions.
(a) Except when dispensed directly by a practitioner other than a pharmacy to an ultimate user, no controlled substance in
Schedule II may be dispensed without the written prescription of a practitioner.
(b) In emergency situations, as defined by rule of the Secretary, Schedule II drugs may be dispensed upon oral prescription
of a practitioner, reduced promptly to writing and filed by the pharmacy. Prescriptions shall be retained in conformity with
the requirements of § 4737. No prescription for a Schedule II substance may be refilled.
(c) Except when dispensed directly by a practitioner other than a pharmacy to an ultimate user, a controlled substance included
in Schedule III or IV which is a prescription drug shall not be dispensed without a written or oral prescription of a practitioner.
The prescription shall not be filled or refilled more than 6 months after the date thereof or be refilled more than 5 times,
unless renewed by the practitioner.
(d) A controlled substance included in Schedule V shall not be distributed or dispensed other than for a medical purpose.
16 Del. C. 1953, § 4738; 58 Del. Laws, c. 424, § 1; 60 Del. Laws, c. 583, § 5.;
§ 4740. Sale of pseudoephedrine or ephedrine.
(a) If any material, compound, mixture, or preparation containing any detectable quantity of pseudoephedrine or ephedrine,
its salts or optical isomers, or salts of optical isomers is dispensed, offered for sale, sold or distributed:
(1) It shall be dispensed, offered for sale, sold, or distributed only from behind a checkout counter, pharmacy counter, or
in a locked storage container where the public is not permitted.
(2) A licensed pharmacist, sales clerk, or pharmacy technician shall require that any person purchasing, receiving, or otherwise
acquiring any such substance shall be age 18 or older, produce a photo identification showing the date of birth of the person,
and sign a written log or receipt showing the date of the transaction, name of the person, and the amount of such substance.
The written log or receipt shall be retained for at least 12 months.
(3) No person, other than a pharmacy or retail establishment, shall purchase, receive, or otherwise acquire more than 9 grams
of any such substance within any 30-day period.
(b) A violation of this section is a class A misdemeanor.
75 Del. Laws, c. 52, § 1; 75 Del. Laws, c. 217, § 1; 77 Del. Laws, c. 334, § 1.;
Subchapter III. Regulation of Manufacture, Distribution and Dispensing of Controlled Substances
§ 4731. Rules; fees.
The Secretary may promulgate rules and charge reasonable fees relating to the registration and control of the manufacture,
distribution and dispensing of controlled substances within this State.
16 Del. C. 1953, § 4731; 58 Del. Laws, c. 424, § 1.;
(a) Any pharmacy, distributor, manufacturer, practitioner, researcher or under the classification of "Other Controlled Substance
Registrants," who has or proposes to engage in activities accordingly within this State must obtain biennially a registration
issued by the Secretary in accordance with the Secretary's rules.
(b) Any pharmacy, distributor, manufacturer, researcher or classified under "Other Controlled Substance Registrants" are limited
to those substances to the extent authorized by their registration and in conformity with the other provisions of this subchapter.
(c) The following persons need not register and may lawfully possess controlled substances under this chapter:
(1) An agent or employee of any registered manufacturer, distributor or dispenser of any controlled substance if the agent
or employee is acting in the usual course of the agent's or employee's business or employment;
(2) A common or contract carrier or warehouseperson, or an employee thereof, whose possession of any controlled substance
is in the usual course of business or employment; and
(3) An ultimate user or a person in possession of any controlled substance pursuant to a lawful order of a practitioner or
in lawful possession of a Schedule V substance.
(d) The Secretary may waive by rule the requirement for registration of certain manufacturers, distributors or dispensers
if the Secretary finds it consistent with the public health and safety.
(e) A separate registration is required at each principal place of business or professional practice where the applicant manufactures,
distributes, dispenses or conducts research with controlled substances. (Includes classification of "Other Controlled Substance
Registrants").
(f) The Secretary or the Secretary's representative may inspect the establishment of a registrant or applicant for registration
in accordance with the Secretary's rule.
(g) Every registrant under this chapter shall be required to report any change of professional or business address in such
a manner as the Secretary may require by regulation.
16 Del. C. 1953, § 4732; 58 Del. Laws, c. 424, § 1; 65 Del. Laws, c. 501, §§ 1, 2; 70 Del. Laws, c. 186, § 1; 71 Del. Laws, c. 288, § 7.;
§ 4733. Registration; rights of registrants.
(a) The Secretary shall register an applicant as a pharmacy, distributor, manufacturer, practitioner, research or under the
classification, "Other Controlled Substance Registrants" controlled substances included in §§ 4714, 4716, 4718, 4720 and 4722
unless the Secretary determines that the issuance of that registration would be inconsistent with the public interest. In
determining the public interest, the Secretary shall consider the following factors:
(1) Maintenance of effective controls against diversion of controlled substances into other than legitimate medical, scientific
or industrial channels;
(2) Compliance with applicable state and local law includes such requirements as having a license to practice as a practitioner
or having documented training and continuing education as a drug detection animal trainer;
(3) Any convictions of the applicant under any federal and state laws relating to any controlled substance;
(4) Past experience in the manufacture or distribution of controlled substances and the existence in the applicant's establishment
of effective controls against diversion;
(5) Furnishing by the applicant of false or fraudulent material in any application filed under this chapter;
(6) Suspension or revocation of the applicant's federal registration to manufacture, distribute, prescribe, dispense or research
controlled substances as authorized by federal law; and
(7) Any other factors relevant to and consistent with the public health and safety.
(b) Registration under subsection (a) does not entitle a registrant to manufacture, research and distribute controlled substances
including the classification of "Other Controlled Substance Registrants" in Schedule I or II other than those specified in
the registration.
(c) Practitioners must be registered to dispense any controlled substances or to conduct research with controlled substances
in Schedules II through V if they are authorized to dispense or conduct research under the law of this State. The Secretary
need not require separate registration under this subchapter for practitioners engaging in research with nonnarcotic controlled
substances in Schedules II through V where the registrant is already registered under this subchapter in another capacity.
Practitioners registered under federal law to conduct research with Schedule I substances may conduct research with Schedule
I substances within this State upon furnishing the Secretary evidence of that federal registration.
(d) Compliance by manufacturers and distributors with the federal law respecting registration (excluding fees) entitles them
to be registered under this chapter.
16 Del. C. 1953, § 4733; 58 Del. Laws, c. 424, § 1; 70 Del. Laws, c. 186, § 1; 71 Del. Laws, c. 288, § 8.;
§ 4734. Revocation and suspension of registration.
(a) A registration under § 4733 of this title as a pharmacy, distributor, manufacturer, practitioner, researcher or under
the classification of "Other Controlled Substance Registrants" may be suspended or revoked by the Secretary upon a finding
that continued registration would be inconsistent with the public interest. In determining the public interest, the Secretary
shall consider the following factors:
(1) Maintenance of effective controls against diversion of controlled substances into other than legitimate medical, scientific
or industrial channels;
(2) Compliance with applicable state and local law including such events as a practitioner losing their license to practice
or a drug detection animal trainer not obtaining or maintaining formal training and continuing education;
(3) Any convictions of the registrant under any federal and state laws relating to any controlled substance;
(4) The existence in the registrant's establishment of effective controls against diversion;
(5) Furnishing by the registrant of false or fraudulent material in any application filed under this chapter;
(6) Suspension or revocation of the registrant's federal registration to manufacture, distribute, prescribe, dispense or research
controlled substances as authorized by federal law; and
(7) Any other factors relevant to and consistent with the public health and safety.
(b) The Secretary may limit revocation or suspension of a registration to the particular controlled substance with respect
to which grounds for revocation or suspension exist.
(c) If the Secretary suspends or revokes a registration, all controlled substances owned or possessed by the registrant at
the time of suspension or the effective date of the revocation order may be placed under seal. No disposition may be made
of substances under seal until the time for taking an appeal has elapsed or until all appeals have been concluded unless a
court upon application therefor orders the sale of perishable substances and the deposit of the proceeds of the sale with
the court. Upon a revocation order becoming final, all controlled substances may be forfeited to the State.
(d) The Secretary shall promptly notify the Administration of all orders suspending or revoking registration and all forfeitures
of controlled substances.
16 Del. C. 1953, § 4734; 58 Del. Laws, c. 424, § 1; 60 Del. Laws, c. 583, § 4; 71 Del. Laws, c. 288, § 9.;
§ 4735. Order to show cause and subpoena; judicial review.
(a) Before denying, suspending or revoking a registration or refusing a renewal of registration, the Secretary shall serve
upon the applicant or registrant an order to show cause why registration should not be denied, revoked or suspended or why
the renewal should not be refused. The order to show cause shall contain a statement of the basis therefor and shall call
upon the applicant or registrant to appear before the Secretary at a time and place not less than 30 days after the date of
service of the order, but in the case of a denial or renewal of registration the show cause order shall be served not later
than 30 days before the expiration of the registration. These proceedings shall be conducted in accordance with the procedures
established by the Secretary without regard to any criminal prosecution or other proceeding. Proceedings to refuse renewal
of registration shall not abate the existing registration which shall remain in effect pending the outcome of the administrative
hearing.
(b) The Secretary may suspend, without an order to show cause, any registration simultaneously with the institution of proceedings
under § 4734 or where renewal of registration is refused, if the Secretary finds that there is an imminent danger to the public
health or safety which warrants this action. The suspension shall continue in effect until the conclusion of the proceedings,
including judicial review thereof, unless sooner withdrawn by the Secretary or dissolved by a court of competent jurisdiction.
(c) Any person complained against under this subchapter may appear personally or by counsel at the hearing and produce any
competent evidence in the person's behalf in answer to the alleged violation. The Secretary shall be authorized to administer
oaths, examine witnesses and issue, in the name of the Department of Health and Social Services, notices of hearings or subpoenas
requiring the testimony of witnesses and the production of books, records or other documents relevant to any matter involved
in such hearing, and subpoenas shall also be issued at the request of the applicant or person complained against. In case
of contumacy or refusal to obey a notice of hearing or subpoena under this section, the Superior Court in the county in which
the hearing is held shall have jurisdiction, upon application of the Secretary to issue an order requiring such person to
appear and testify or produce evidence as the case may require.
(d) Any party in interest aggrieved by a decision of the Secretary to deny, suspend, revoke or refuse to renew registration
under this subchapter may appeal such decision to Superior Court. Such appeal shall be on the record and the only question
before said Court shall be whether the Secretary abused the Secretary's discretion. When notified of an appeal under this
section, the Secretary shall forward to Superior Court a certified and complete copy of the written transcripts or taped voice
records of evidence adduced at the hearing before the Secretary together with a written copy of the Secretary's findings and
rulings and the Secretary's reasons therefor.
16 Del. C. 1953, § 4735; 58 Del. Laws, c. 424, § 1; 70 Del. Laws, c. 186, § 1.;
§ 4736. Authority of Secretary to impose fines.
(a) Whenever the Secretary has found a registrant to be guilty of a violation of this chapter or of rules adopted pursuant
to this chapter, the Secretary shall, in addition to the power and authority granted the Secretary in this chapter, have the
power to impose a fine on the registrant for such violation and require that such fine be paid, with the sanction that the
person's registration may be suspended until the fine is paid. No fine imposed by the Secretary may exceed $500.
(b) Prior to the imposition of any fine, the Secretary shall hold an investigation and hearing after notice to the registrant
or the registrant's attorney. A fine shall be imposed by the Secretary only upon finding that:
(1) The public welfare and morals would not be impaired by the imposition of such fine; and
(2) Payment of the sum of money will achieve the desired disciplinary purposes.
(c) The Secretary shall not impose a fine on a registrant whose registration has been revoked by the Secretary for such violation.
The power and authority of the Secretary to impose such fines is not to be affected by any other proceeding, civil or criminal,
concerning the same violation, nor shall the imposition of such fine preclude the Secretary from imposing other sanctions
short of revocation.
(d) Any person so fined may appeal to the Superior Court for a trial de novo, provided the appeal is taken within 15 days
of the time of the decision of the Secretary.
60 Del. Laws, c. 583, § 5; 70 Del. Laws, c. 186, § 1.;
§ 4737. Records of registrants.
Persons registered to manufacture, distribute or dispense controlled substances under this chapter shall keep records and
maintain inventories in conformance with the record-keeping and inventory requirements of federal law and with any additional
rules the Secretary issues.
16 Del. C. 1953, § 4736; 58 Del. Laws, c. 424, § 1; 60 Del. Laws, c. 583, § 5.;
§ 4738. Order forms.
Controlled substances in Schedules I and II shall be distributed by a registrant to another registrant only pursuant to an
order form. Compliance with federal law respecting order forms shall be deemed compliance with this section.
16 Del. C. 1953, § 4737; 58 Del. Laws, c. 424, § 1; 60 Del. Laws, c. 583, § 5.;
§ 4739. Prescriptions.
(a) Except when dispensed directly by a practitioner other than a pharmacy to an ultimate user, no controlled substance in
Schedule II may be dispensed without the written prescription of a practitioner.
(b) In emergency situations, as defined by rule of the Secretary, Schedule II drugs may be dispensed upon oral prescription
of a practitioner, reduced promptly to writing and filed by the pharmacy. Prescriptions shall be retained in conformity with
the requirements of § 4737. No prescription for a Schedule II substance may be refilled.
(c) Except when dispensed directly by a practitioner other than a pharmacy to an ultimate user, a controlled substance included
in Schedule III or IV which is a prescription drug shall not be dispensed without a written or oral prescription of a practitioner.
The prescription shall not be filled or refilled more than 6 months after the date thereof or be refilled more than 5 times,
unless renewed by the practitioner.
(d) A controlled substance included in Schedule V shall not be distributed or dispensed other than for a medical purpose.
16 Del. C. 1953, § 4738; 58 Del. Laws, c. 424, § 1; 60 Del. Laws, c. 583, § 5.;
§ 4740. Sale of pseudoephedrine or ephedrine.
(a) If any material, compound, mixture, or preparation containing any detectable quantity of pseudoephedrine or ephedrine,
its salts or optical isomers, or salts of optical isomers is dispensed, offered for sale, sold or distributed:
(1) It shall be dispensed, offered for sale, sold, or distributed only from behind a checkout counter, pharmacy counter, or
in a locked storage container where the public is not permitted.
(2) A licensed pharmacist, sales clerk, or pharmacy technician shall require that any person purchasing, receiving, or otherwise
acquiring any such substance shall be age 18 or older, produce a photo identification showing the date of birth of the person,
and sign a written log or receipt showing the date of the transaction, name of the person, and the amount of such substance.
The written log or receipt shall be retained for at least 12 months.
(3) No person, other than a pharmacy or retail establishment, shall purchase, receive, or otherwise acquire more than 9 grams
of any such substance within any 30-day period.
(b) A violation of this section is a class A misdemeanor.
75 Del. Laws, c. 52, § 1; 75 Del. Laws, c. 217, § 1; 77 Del. Laws, c. 334, § 1.;
