Section R4-23-604. Resident Drug Manufacturer

A.      Permit. A person shall not manufacture, package, repackage, label, or relabel any narcotic or other controlled substance, prescription-only drug or device, nonprescription drug, precur- sor chemical, or regulated chemical without a current Board- issued drug manufacturer permit.

B.       Application. To obtain a permit to operate a drug manufactur- ing firm in Arizona, a person shall submit a completed appli- cation, on a form furnished by the Board, that includes:

1.        Business name, address, mailing address, if different, telephone number, and facsimile number;

2.        Owner's name, if corporation or partnership, officers or partners, including address and title, and any other trade or business names used;

3.        Whether the owner, corporation, or partnership has con- ducted a similar business in any other jurisdiction and if so, indicate under what name and location;

4.        Whether the owner, any officer, or active partner has ever been convicted of an offense involving moral turpitude, a felony offense, or any drug-related offense or has any currently pending felony or drug-related charges, and if so, indicate charge, conviction date, jurisdiction, and location;

5.        Whether the owner, any officer, or active partner has ever been denied a drug manufacturer permit in this state or any other jurisdiction, and if so, indicate where and when;

6.        A copy of the drug list required by the FDA;

7.        Plans or construction drawings showing facility size and security for the proposed business;

8.        Applicant's and manager's name, address, emergency telephone number, and resumé indicating educational or experiential qualifications related to drug manufacturer operation;

9.        The applicant's current FDA drug manufacturer or repackager registration number and expiration date;

10.     Documentation of compliance with local zoning laws;

11.     For an application submitted because of ownership change, the former owner's name and business name, if different;

12.     Date signed, and applicant's, corporate officer's, partner's, or manager's verified signature and title; and

13.     Fee specified in R4-23-205.

C.      Before issuing a drug manufacturer permit, the Board shall:

1.        Receive and approve a completed permit application;

2.        Interview the applicant and manager, if different from the applicant, at a Board meeting; and

3.        Receive a satisfactory compliance inspection report on the facility from a Board compliance officer.

D.      Notification. A resident drug manufacturer permittee shall notify the Board of changes involving the drug list, ownership, address, telephone number, name of business, or manager, including manager's telephone number. The resident drug manufacturer permittee shall submit a written notice via mail, fax, or e-mail to the Executive Director within 24 hours of the change, except any change of ownership requires that the resi- dent drug manufacturer permittee comply with subsection (E).

E.       Change of ownership. Before a change of ownership occurs that involves changes of stock ownership of more than 30% of the voting stock of a corporation or an existing and continuing corporation that is not actively traded on any securities market or over-the-counter market, the prospective owner shall submit the application packet described under subsection R4-23- 604(B).

F.       Before an existing resident drug manufacturer permittee relo- cates, the drug manufacturer permittee shall submit the appli- cation packet described in subsection  R4-23-604(B), excluding the fee. The facility at the new location shall pass a final inspection by a Board compliance officer before opera- tions begin.

G.      A resident drug manufacturer permittee shall submit the appli- cation packet described under subsection R4-23-604(B) for any change of officers in a corporation, excluding the fee and final inspection.

H.      Manufacturing and distribution.

1.        A drug manufacturer permittee shall manufacture and distribute a drug only:

a.         To a pharmacy, drug manufacturer, or full-service or nonprescription drug wholesaler currently permitted by the Board;

b.        To a  medical practitioner  currently  licensed  as a medical practitioner as defined in A.R.S. § 32-1901; or

c.         To a properly permitted, registered, licensed, or cer- tified person or firm of another jurisdiction.

2.        Before manufacturing and distributing a drug that is not listed on a drug manufacturer's permit application, the drug manufacturer permittee shall send to the Board office a written request to amend the permit application, including documentation of FDA approval to manufac- ture the drug not listed on the original permit application. If a request to amend a permit application includes the documentation required in this subsection, the Board or

its designee shall approve the request to amend within 30 days of receipt.

I.        A drug manufacturer permit is subject to denial, suspension, probation, or revocation under A.R.S. § 32-1927.02.

J.        Current Good Manufacturing Practice. A drug manufacturer permittee shall comply with the current good manufacturing practice requirements of 21 CFR 210 through 211, (Revised April 1, 2011, incorporated by reference and on file with the Board and available at www.gpo.gov. This incorporated mate- rial includes no future editions or amendments.)

K.        Records. A drug manufacturer permittee shall:

1.        Establish and implement written procedures for maintain- ing records pertaining to production, process control, labeling, packaging, quality control, distribution, com- plaints, and any information required by federal or state law;

2.        Retain the records required by this Article and 21 CFR 210 through 211 as incorporated in subsection (J) for at least two years after distribution of a drug or one year after the expiration date of a drug, whichever is longer; and

3.        Make the records required by this Article and 21 CFR 210 through 211 as incorporated in subsection (J) avail- able within 48 hours for review by a Board compliance officer or other authorized officer of the law as defined in A.R.S. § 32-1901(5).

L.       Inspections. A drug manufacturer permittee shall make the drug manufacturer's facility available for inspection by the Board or its compliance officer under A.R.S. § 32-1904.

M.     Nonresident drug manufacturer. A nonresident drug manufac- turer shall comply with the requirements of R4-23-607.

N.      Manufacturing radiopharmaceuticals. Before manufacturing a radiopharmaceutical, a drug manufacturer permittee shall:

1.        Comply with the regulatory requirements of the Arizona Radiation Regulatory Agency, the U.S. Nuclear Regula- tory Commission, the FDA, and this Section; and

2.        Hold a current Arizona  Radiation Regulatory Agency Radioactive Materials License. If a drug manufacturer permittee who manufactures radiopharmaceuticals fails to maintain a current Arizona Radiation Regulatory Agency Radioactive Materials License, the permittee's drug manufacturer permit shall be immediately sus- pended pending a hearing by the Board.

Historical Note

Former Rules 6.4001, 6.4002, 6.4003, 6.4004, 6.4005,

6.4006, 6.4007, 6.4008, 6.4009, 6.4100, 6.4110, 6.4111,

6.4115, 6.4116, 6.4120, 6.4122, 6.4190, 6.4191, 6.4200,

6.4250, 6.4300, 6.4350, 6.4355, 6.4360, 6.4400, 6.4401,

6.4403, 6.4410, 6.4430, 6.4450, 6.4500, 6.4510, 6.4530,

6.4533, 6.4600, 6.4610, 6.4640, 6.4660, 6.4700, 6.4710,

and 6.4750. Adopted effective December 3, 1974 (Supp.

75-1). Amended effective August 10, 1978 (Supp. 78-4). Amended subsection (B) paragraph (2) effective April 20, 1982 (Supp. 82-2). Amended subsections (B), (G), (K) and (L) effective August 12, 1988 (Supp. 88-3).

Amended effective August 24, 1992 (Supp. 92-3).

Amended effective November 1, 1993 (Supp. 93-4). Amended by final rulemaking at 7 A.A.R. 3815, effective August 9, 2001 (Supp. 01-3). Amended by final rulemak-

ing at 11 A.A.R. 1105, effective April 30, 2005 (Supp.

05-1). Amended by final rulemaking at 19 A.A.R. 702,

effective June 1, 2013 (Supp. 13-2).