Sec. 21a-70. (Formerly Sec. 19-210). Registration of manufacturers and wholesalers of drugs. Sale of drugs limited.
Sec. 21a-70. (Formerly Sec. 19-210). Registration of manufacturers and
wholesalers of drugs. Sale of drugs limited. (a) Definitions. As used in this section:
(1) "Wholesaler" or "distributor" means a person, whether within or without the boundaries of the state of Connecticut, who supplies drugs, medical devices or cosmetics
prepared, produced or packaged by manufacturers, to other wholesalers, manufacturers,
distributors, hospitals, prescribing practitioners, as defined in subdivision (22) of section
20-571, pharmacies, federal, state or municipal agencies, clinics or any other person as
permitted under subsection (h) of this section, except that a retail pharmacy or a pharmacy within a licensed hospital which supplies to another such pharmacy a quantity of
a noncontrolled drug or a schedule III, IV or V controlled substance normally stocked
by such pharmacies to provide for the immediate needs of a patient pursuant to a prescription or medication order of an authorized practitioner, a pharmacy within a licensed
hospital which supplies drugs to another hospital or an authorized practitioner for research purposes, and a retail pharmacy which supplies a limited quantity of a noncontrolled drug or of a schedule II, III, IV or V controlled substance for emergency stock
to a practitioner who is a medical director of a chronic and convalescent nursing home,
of a rest home with nursing supervision or of a state correctional institution shall not
be deemed a wholesaler under this section; (2) "manufacturer" means a person whether
within or without the boundaries of the state of Connecticut who produces, prepares,
cultivates, grows, propagates, compounds, converts or processes, directly or indirectly,
by extraction from substances of natural origin or by means of chemical synthesis or
by a combination of extraction and chemical synthesis, or who packages, repackages,
labels or relabels a container under such manufacturer's own or any other trademark or
label any drug, device or cosmetic for the purpose of selling such items. The words
"drugs", "devices" and "cosmetics" shall have the meaning ascribed to them in section
21a-92; and (3) "commissioner" means the Commissioner of Consumer Protection.
(b) Registration of wholesalers and manufacturers of drugs required. Exception. Fees. Expenses. No wholesaler or manufacturer shall operate as such until he has
received a certificate of registration issued by the commissioner, which certificate shall
be renewed annually, provided no such certificate shall be required of a manufacturer
whose principal place of business is located outside the state, who is registered with the
federal Food and Drug Administration or any successor agency and who files a copy
of such registration with the commissioner. A fee of one hundred fifty dollars shall be
charged for each wholesaler's certificate and renewal thereof and the fee for a manufacturer's certificate and renewal thereof shall be two hundred twenty-five dollars for manufacturers employing not more than five licensed pharmacists or qualified chemists or
both; three hundred dollars for manufacturers employing not more than ten licensed
pharmacists or qualified chemists or both; and seven hundred fifty dollars for manufacturers employing more than ten licensed pharmacists or qualified chemists or both. No
such certificate shall be issued to a manufacturer unless such drugs, medical devices or
cosmetics are manufactured or compounded under the direct supervision of a licensed
pharmacist or a qualified chemist. No certificate of registration shall be issued under
this section until the applicant has furnished proof satisfactory to the commissioner that
the applicant is equipped as to facilities and apparatus to properly carry on the business
described in his application and that the applicant conforms to chapter 418 and regulations adopted thereunder.
(c) Commissioner's right to deny certificate. The commissioner shall have the
right to deny a certificate of registration if he determines that the issuance of such registration is inconsistent with the public interest. In determining the public interest, the
commissioner shall consider, at a minimum, the following factors:
(1) Any convictions or regulatory actions involving the applicant under any federal,
state or local law relating to drug samples, wholesale or retail drug distribution, or
distribution or possession of drugs including controlled substances;
(2) Any felony convictions of the applicant under federal, state or local laws;
(3) The applicant's past experience in the manufacture or distribution of drugs;
(4) The furnishing by the applicant of false or fraudulent material in any application
made in connection with drug manufacturing or distribution;
(5) Suspension, revocation or other sanction by federal, state or local government
of any license or registration currently or previously held by the applicant for the manufacture or distribution of any drugs;
(6) Compliance with licensing or registration requirements under previously
granted licenses or registrations;
(7) Compliance with requirements to maintain or make available to the commissioner or to federal, state or local law enforcement officials those records required by
any federal or state statute or regulation;
(8) Failure to provide adequate control against the diversion, theft and loss of drugs;
(9) Provision of required security for legend drugs and, in the case of controlled
substances, compliance with security requirements for wholesalers set forth in regulations adopted under chapter 420b; and
(10) Compliance with all regulations adopted to enforce the provisions of this
section.
(d) Suspension, revocation or refusal to renew registration. The commissioner
may suspend, revoke or refuse to renew a registration, or may issue a letter of reprimand
or place a registrant on probationary status, for sufficient cause. Any of the following
shall be sufficient cause for such action:
(1) The furnishing of false or fraudulent information in any application or other
document filed with the commissioner;
(2) Any criminal conviction of the registrant under any federal or state statute concerning drugs;
(3) The suspension, revocation or other restriction or penalty issued against a license
or registration related to drugs;
(4) Failure to provide adequate control against the diversion, theft and loss of
drugs; or
(5) A violation of any provision of any federal or state statute or regulation concerning drugs.
(e) Compliance with applicable laws. Wholesalers shall operate in compliance
with applicable federal, state and local statutes, regulations and ordinances, including
any applicable laws concerning controlled substances, drug product salvaging or reprocessing.
(f) Inspections and audits. Wholesalers and manufacturers shall permit the commissioner, or his authorized representatives, to enter and inspect their premises and
delivery vehicles, and to audit their records and written operating procedures, at reasonable times and in a reasonable manner.
(g) Hearings. Before denying, suspending, revoking or refusing to renew a registration, or before issuing a letter of reprimand or placing a registrant on probationary status,
the commissioner shall afford the applicant or registrant an opportunity for a hearing
in accordance with the provisions of chapter 54. Notice of such hearing may be given
by certified mail. The commissioner may subpoena witnesses and require the production
of records, papers and documents pertinent to such hearing.
(h) Sale of drugs limited. Regulations. No manufacturer or wholesaler shall sell
any drugs except to the state or any political subdivision thereof, to another manufacturer
or wholesaler, to any hospital recognized by the state as a general or specialty hospital,
to any institution having a full-time pharmacist who is actively engaged in the practice
of pharmacy in such institution not less than thirty-five hours a week, to a chronic and
convalescent nursing home having a pharmacist actively engaged in the practice of
pharmacy based upon the ratio of one-tenth of one hour per patient per week but not
less than twelve hours per week, to a practicing physician, podiatrist, dentist, optometrist
or veterinarian or to a licensed pharmacy or a store to which a permit to sell nonlegend
drugs has been issued as provided in section 20-624. The commissioner may adopt such
regulations as are necessary to administer and enforce the provisions of this section.
(i) Penalty. Any person who violates any provision of this section shall be fined
not more than five hundred dollars or imprisoned not more than six months or both.
(1949 Rev., S. 3925-3928; 1951, S. 2089d; 1959, P.A. 412, S. 38, 42; 593, S. 1; February, 1965, P.A. 519; 1971, P.A.
115; P.A. 74-298, S. 1, 2; P.A. 75-279, S. 1, 2; P.A. 76-228, S. 1, 2; P.A. 77-73; 77-170; P.A. 78-53, S. 2; 78-310, S. 1, 4;
P.A. 79-13; P.A. 84-194, S. 1; P.A. 86-13, S. 1, 4; P.A. 89-251, S. 152, 203; P.A. 92-181, S. 2, 3; P.A. 93-55, S. 8; P.A.
95-264, S. 54; June Sp. Sess. P.A. 00-2, S. 14, 53; June Sp. Sess. P.A. 01-9, S. 25, 131; June 30 Sp. Sess. P.A. 03-6, S.
146(c); P.A. 04-189, S. 1.)
History: 1959 acts created distinction between fees for wholesalers' and manufacturers' certificates in Subsec. (b),
adding provisions re manufacturers' certificates; 1965 act deleted "manufacturers" from wholesaler's activities, changed
"medical devices" to "proprietary medicines," extended wholesaler to mean person within or without the state, limited
reselling to "within the state", confined the meaning of "manufacturer" to a person "within the state" and replaced commissioner of food and drugs with commissioner of consumer protection; 1971 act deleted provision prohibiting issuance of
certificate to wholesaler unless drugs, etc. dispensed under direct supervision of licensed pharmacist or qualified chemist;
P.A. 74-298 redefined "wholesaler" and "manufacturer" to replace references to bottling, packing and purchase or manufacture of drugs, medicine, cosmetics, etc.; P.A. 75-279 revised sale prohibition in Subsec. (c) to except other manufacturers
and wholesalers and podiatrists and to delete dispensary reference and to add provision re adoption of necessary regulations;
P.A. 76-228 increased fees in Subsec. (b): For wholesalers, from $50 to $75, for manufacturers, from $75 to $112.50 for
those employing not more than five licensed pharmacists or chemists or both, from $100 to $150 for those employing not
more than ten and from $250 to $375 for those employing more than ten; P.A. 77-73 included manufacturers outside
Connecticut as well as those within in Subsec. (a), added proviso re exemption from certificate requirements for those
whose principal place of business is outside the state and required proof of proper facilities and equipment and of conformity
with chapter 342 in Subsec. (b) and qualified sales to institutions with full-time pharmacists in Subsec. (c) by requiring
that pharmacist practice at least 35 hours per week; P.A. 77-170 excepted retail pharmacies and pharmacies within licensed
hospitals from definition of "wholesaler" in certain specified circumstances; P.A. 78-53 included schedule III, IV or V
controlled substances in exception for retail pharmacies and pharmacies within licensed hospitals added in 1977 act; P.A.
78-310 referred to "manufacturer's certificate" rather than "drug manufacturer's certificate" in Subsec. (b); P.A. 79-13
applied definition of "wholesaler" to "distributor" as well; Sec. 19-210 transferred to Sec. 21a-70 in 1983; P.A. 84-194
amended Subsec. (a) to specifically exclude from the definition of "wholesaler" or "distributor" a retail pharmacy which
supplies certain controlled and noncontrolled drugs to medical directors of convalescent nursing homes or rest homes;
P.A. 86-13 amended Subsec. (c) to authorize sales to optometrists; P.A. 89-251 amended Subsec. (b) to increase fee for a
wholesaler's certificate from $75 to $150, for a manufacturer employing not more than five pharmacists or chemists from
$112.50 to $225, for a manufacturer employing not more than ten pharmacists or chemists, from $150 to $300, and for a
manufacturer employing more than ten pharmacists or chemists from $375 to $750; P.A. 92-181 amended Subsec. (a) to
define "commissioner", inserted a new Subsec. (c) re commissioner's right to deny a certificate and grounds for denying
certificate, new Subsec. (d) re commissioner's other powers and what would constitute "sufficient cause" for the commissioner to exercise those powers and new Subsecs. (e), (f) and (g) re duties of wholesalers and the right of the commissioner
to enter and inspect premises and delivery vehicles and to audit records and the commissioner's duties with regard to
affording the applicant with proper notice and hearing, relettering former Subsecs. (c) and (d) accordingly; P.A. 93-55
made technical change in Subsec. (a); P.A. 95-264 changed "licensed" practitioner to "prescribing" practitioner in Subsec.
(a) and changed "proprietary and patent medicines" to "nonlegend drugs" in Subsec. (i) (Revisor's note: The reference in
Subsec. (a) to "prescribing practitioner, as defined in subdivision (21) of ..." was changed editorially by the Revisors to
"prescribing practitioner, as defined in subdivision (22) of ..."); June Sp. Sess. P.A. 00-2 amended Subsec. (h) to authorize
sales of drugs to certain chronic and convalescent nursing homes, effective July 1, 2000; June Sp. Sess. P.A. 01-9 amended
Subsec. (a) to add provision re state correctional institution to the definition of "wholesaler" and to make a technical change
for purposes of gender neutrality, effective July 1, 2001; June 30 Sp. Sess. P.A. 03-6 replaced Commissioner of Consumer
Protection with Commissioner of Agriculture and Consumer Protection, effective July 1, 2004; P.A. 04-189 repealed Sec.
146 of June 30 Sp. Sess. P.A. 03-6, thereby reversing the merger of the Departments of Agriculture and Consumer Protection,
effective June 1, 2004.