Section 08.80.157. Licensing of facilities.

   (a) A facility engaged in the practice of pharmacy or in the manufacture, production, or wholesale distribution of drugs or devices, and a pharmacy where drugs or devices are dispensed, shall be licensed by the board, and shall renew the license at intervals determined by the board. If operations are conducted at more than one location, each location shall be licensed by the board.
   (b) The board may by regulation determine the licensure classifications of facilities and establish minimum standards for the facilities.
   (c) The board shall establish by regulation the criteria that a facility must meet to qualify for licensure in each classification. The board may issue licenses with varying restrictions to facilities when the board considers it necessary to protect the public interest.
   (d) The board may deny or refuse to renew a license if it determines that the granting or renewing of the license would not be in the public interest.
   (e) Licenses issued by the board are not transferable or assignable.
   (f) The board shall specify by regulation the minimum standards for responsibility of a facility or pharmacy that has employees or personnel engaged in the practice of pharmacy or engaged in the manufacture, wholesale distribution, production, or use of drugs or devices in the conduct of its business.
   (g) A licensed facility shall report to the board
        (1) permanent closing;
        (2) change of ownership; management, location, or pharmacist-in-charge of a pharmacy;
        (3) theft or loss of drugs or devices as defined by regulations of the board;
        (4) conviction of an employee of violation of a state or federal drug law;
        (5) disasters, accidents, theft, destruction, or loss relating to records required to be maintained by state or federal law;
        (6) occurrences of significant adverse drug reactions as defined by regulations of the board;
        (7) other matters and occurrences the board may require by regulation.
   (h) The board may suspend, revoke, deny, or refuse to renew the license of a facility or pharmacy on the following grounds:
        (1) the finding by the board of violations of a federal, state, or local law relating to the practice of pharmacy, drug samples, wholesale or retail drug or device distribution, or distribution of controlled substances;
        (2) a felony conviction under federal, state, or local law of an owner of the facility or pharmacy or of an employee of the facility or pharmacy;
        (3) the furnishing of false or fraudulent material in an application made in connection with drug or device manufacturing or distribution;
        (4) suspension or revocation by federal, state, or local government of a license currently or previously held by the applicant for the manufacture or distribution of drugs or devices, including controlled substances;
        (5) obtaining remuneration by fraud, misrepresentation, or deception;
        (6) dealing with drugs or devices that are known or should have been known to be stolen drugs or devices;
        (7) dispensing or distributing drugs or devices directly to patients by a wholesale drug distributor other than a pharmacy;
        (8) violation of this chapter or a regulation adopted under this chapter.
   (i) The board's regulations under (b) - (d) and (f) of this section may not establish more stringent licensing requirements for the facilities governed by AS 08.80.390 than are set out in AS 08.80.390.
   (j) This section does not apply to the offices of physicians, osteopaths, podiatrists, physician assistants, advanced nurse practitioners, dentists, veterinarians, dispensing opticians, or optometrists.

Authorities

8.80.160; 8.80.480

Notes

Recent Bills that will modify this

HB 9 PHARMA BD & EMPLOYEES;DRUG DIST/MANUFAC
HB 297 PHARMA BD & EMPLOYEES;DRUG DIST/MANUFAC
SB 201 PHARMA BD & EMPLOYEES;DRUG DIST/MANUFAC

Implemented As

12 AAC 52.010
12 AAC 52.020
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12 AAC 52.060
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12 AAC 52.645
12 AAC 52.650
12 AAC 52.660
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12 AAC 52.685
12 AAC 52.690
12 AAC 52.695
12 AAC 52.710
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12 AAC 52.800
12 AAC 52.810
12 AAC 52.820
12 AAC 52.830
12 AAC 52.840
12 AAC 52.850
12 AAC 52.995

References

12 AAC 52.443
12 AAC 52.445
AS 8.80.160 .160">Sec. 08.80.160. Fees.
AS 8.80.480 .480">Sec. 08.80.480. Definitions.

History

(Sec. 15 ch 166 SLA 1980; am Sec. 13 ch 45 SLA 1996)