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1908
LAWS OF MARYLAND
Ch. 240
(1) AS TO ANY FACTORY, WAREHOUSE, CONSULTING
LABORATORY, OR OTHER ESTABLISHMENT IN WHICH ANY PRESCRIPTION
DRUG IS MANUFACTURED, PROCESSED, PACKED, OR HELD, AN
EXTENDED INSPECTION UNDER THIS SECTION SHALL INCLUDE
EVERYTHING IN THE ESTABLISHMENT THAT MAY HAVE A BEARING ON
WHETHER THE ESTABLISHMENT HAS VIOLATED A PROVISION OF THIS
SUBTITLE REGARDING PRESCRIPTION DRUGS, INCLUDING THE
RECORDS, PROCESSES, CONTROLS, AND FACILITIES.
(2) THE AUTHORITY UNDER THIS SUBSECTION TO
CONDUCT EXTENDED INSPECTIONS OF THE RECORDS OF AN
ESTABLISHMENT THAT RELATE TO PRESCRIPTION DRUGS DOES NOT
INCLUDE THE AUTHORITY TO INSPECT RECORDS OF THE
ESTABLISHMENT THAT RELATE TO:
(I) FINANCIAL INFORMATION;
(II) SALE INFORMATION, OTHER THAN SHIPMENT
INFORMATION;
(III) PRICING INFORMATION;
(IV) PERSONNEL INFORMATION, OTHER THAN
INFORMATION AS TO THE QUALIFICATIONS OF TECHNICAL AND
PROFESSIONAL PERSONNEL WHO PERFORM FUNCTIONS SUBJECT TO THIS
SUBTITLE; OR
(V) RESEARCH INFORMATION, OTHER THAN
INFORMATION THAT:.
1. RELATES TO A NEW DRUG OR AN
ANTIBIOTIC DRUG AND IS SUBJECT TO REQUIREMENTS FOR REPORTING
AND INSPECTION THAT ARE IMPOSED BY RULES AND REGULATIONS
ADOPTED UNDER § 355(I) OR (J) OR § 357 (D) OR (G) OF THE
FEDERAL ACT; OR
2. RELATES TO ANY OTHER DRUG AND
WOULD BE SUBJECT TO REPORTING OR INSPECTION UNDER RULES AND
REGULATIONS ADOPTED UNDER § 355 (J) OF THE FEDERAL ACT.
(3) AUTHORITY TO CONDUCT EXTENDED INSPECTIONS
UNDER THIS SUBSECTION DOES NOT APPLY TO:
(I) ANY PHARMACY THAT COMPLIES WITH THE
LAWS OF THIS STATE THAT REGULATE PRACTICING PHARMACY OR
MEDICINE AND THAT DOES NOT, THROUGH A SUBSIDIARY OR
OTHERWISE, MANUFACTURE, PREPARE, PROPAGATE, COMPOUND, OR
PROCESS ANY DRUG FOR SALE, OTHER THAN IN THE REGULAR COURSE
OF ITS BUSINESS OF DISPENSING OR SELLING DRUGS AT RETAIL;
(II) ANY HEALTH PRACTITIONER WHO IS
AUTHORIZED BY LAW TO PRESCRIBE OR ADMINISTER DRUGS AND WHO
MANUFACTURES, PREPARES, PROPAGATES, COMPOUNDS, OR PROCESSES
A DRUG SOLELY FOR USE IN THE COURSE OF THE PRACTITIONER'S
PROFESSIONAL PRACTICE;
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