Marvin Mandel, Governor                         867

191C.

(a) For purposes of enforcement of this subheading, the Secre-
tary or any of his authorized agents, are authorized upon presenting
appropriate credentials to the owner, operator or agent in charge
to enter at reasonable times any factory, warehouse or establishment
in which food, drugs, devices or cosmetics are manufactured, proc-
essed, packed or held for introduction into commerce or after such in-
troduction or to enter any vehicle being used to transport or hold
the food, drugs, devices or cosmetics in commerce; and to inspect
at reasonable times and within reasonable limits and in a reasonable
manner the factory, warehouse, establishment or vehicle and all
pertinent equipment, finished and unfinished materials, containers
and labeling therein, and to obtain samples necessary to the enforce-
ment of this subheading. In the case of any factory, warehouse,
establishment or consulting laboratory in which prescription drugs
are manufactured, processed, packed or held, the inspection shall
extend to all things therein (including records, files, papers, proc-
esses, controls, and facilities) bearing on whether prescription drugs
which are adulterated or misbranded within the meaning of this
subheading or which are prohibited from being manufactured, in-
troduced into commerce or sold or offered for sale by reason of any
provision of this subheading, have been or are being manufactured,
processed, packed, transported or held in any such place or otherwise
bearing on violation of this subheading. No inspection authorized
for prescription drugs by the preceding sentence shall extend to (i)
financial data, (ii) sales data other than shipment data, (iii) pricing
data, (iv) personnel data (other than data as to the qualifications
of technical and professional personnel performing functions subject
to this subheading, and (v) research data (other than data, relating
to new drugs and antibiotic drugs, subject to reporting and inspection
under regulations lawfully issued pursuant to Section 501 (i) 505 or
(j) or 355 (I) OR (J) OR Section 507 357 (d) or (g) of the Federal
Act, and data, relating to other drugs, which in the case of a new
drug would be subject to reporting or inspection under lawful regula-
tions issued pursuant to Section 505 (j) of the Federal Act). The
inspection shall be commenced and completed with reasonable prompt-
ness. The provision of the second sentence of this subsection shall not
apply to:

(1)    pharmacies which maintain establishments in conformance
with Maryland laws regulating the practice of pharmacy and medi-
cine and which are regularly engaged in dispensing prescription
drugs, upon prescriptions of practitioners licensed to administer such
drugs to patients under the care of such practitioners in the course
of their professional practice and which do not, either through a
subsidiary or otherwise, manufacture, prepare, propagate, compound
or process drugs for sale other than in the regular course of their
business of dispensing or selling drugs at retail;

(2)    practitioners licensed by law to prescribe or administer drugs
and who manufacture, prepare, propagate, compound or process
drugs solely for use in the course of their professional practice;

(3)    persons who manufacture, prepare, propagate, compound or
process drugs solely for use in research, teaching or chemical analysis
and not for sale;