233 



which prescription drugs or restricted devices are 

 manufactured, processed, packed, or held, the 

 Inspection shall extend to all things therein 

 (Including records, flies, papers, processes, controls, 

 and facilities) bearing on whether prescription 

 drugs or restricted devices which are adulterated 

 or misbranded within the meaning of this chapter, 

 or which may not be manufactured, introduced into 

 interstate commerce, or sold, or offered for sale by 

 reason of any provision of this chapter, have been c 

 are being manufactured, processed, packed, trans- 

 ported, or held in any such place, or otherwise bear- 

 ing on violation of this chapter No inspection 

 authorized by the preceding sentence shall extend 

 to financial data, sales data other than shipment 

 data, pricing data, personnel data (other than data 

 as to qualifications of technical and professional 

 persormel performing functions subject to this 

 Act), and research data (other than data relating 

 to new drugs, antibiotic drugs, and devices and 

 subject to reporting and inspection under regula- 

 tions lawfully issued pursuant to section 355 (i) or 

 (j), section 357 (d) or (g), section 3601, or 360j(g), 

 and data relating to other drugs or devices which in 

 the case of a new drug would be subject to reporting 

 or inspection under lawful regulations issued 

 pursuant to section 355(j) ) . A separate notice shall 

 be given for each such inspection, but a notice shall 

 not be required for each entry mettle during the 

 period covered by the inspection. Each such inspec- 

 tion shall be commenced and completed with 

 reasonable promptness. The provisions of the 

 second sentence of this subsection shall not apply 

 to- 

 Each such inspection shall be commenced and com- 

 pleted with reasonable promptness. The provisions 

 of the second sentence of this subsection shall not 

 apply to— 



(1) pharmacies which maintain establishments 

 in conformance with any applicable local laws 

 regulating the practice of pharmacy and medicine 

 and which are regularly engaged in dispensing 

 prescription drugs or devices upon prescriptions 

 of practitioners licensed to administer such drugs 

 or devices 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 or devices 

 for sale other than in the regular course of their 

 business of dispensing or selling drugs or devices 

 at retail; 



(2) practitioners licensed by law to prescribe 

 or administer drugs, or prescribe or use devices, 

 as the case may be, and who manufacture, pre- 

 pare, propagate, compoimd, or process drugs, or 

 manufacture or process devices, solely for use in 

 the course of their professional practice; 



(3) persons who manufacture, prepare, propa- 

 gate, compound, or process drugs or manufacture 

 or process devices solely for use in research, 

 teaching, or chemical analysis and not for sale; 



(4) such other classes of persons as the Sec- 

 retary may by regulation exempt from the 



application of this section upon a finding that 

 inspection as applied to such classes of persons in 

 accordance with this section is not necessary for 

 the protection of the public health. 



(b) Written report to owner; copy to Secretary. 

 Upon completion of any such inspection of a fac- 

 tory, warehouse, consulting laboratory, or other es- 

 tablishment, and prior to leaving the premises, the 

 officer or employee making the inspection shall give 

 to the owner, operator, or agent in charge a report 

 in writing setting forth any conditions or practices 

 observed by him which, in his judgment, indicate 

 that any food, drug, device, or cosmetic in such es- 

 tablishment (1) consists in whole or in part of any 

 filthy, putrid, or decomposed substance, or (2) has 

 been prepared, packed, or held under insanitary con- 

 ditions whereby it may have become contaminated 

 with filth, or whereby it may have been rendered 

 injurious to health. A copy of such report shall be 

 sent promptly to the Secretary. 



(c) Receipt for samples taken. 



If the officer or employee making any such inspec- 

 tion of a factory, warehouse, or other establishment 

 has obtained any sample in the cours; of the inspec- 

 tion, upon completion of the inspection and prior to 

 having the premises he shall give to the owner, 

 operator, or agent in charge a receipt describing the 

 samples obtained. 



(d) Analysis of samples furnished owner. 

 Whenever in the courte of any such inspection of 



a factory or other establishment where food is man- 

 ufactured, processed, or packed, the officer or em- 

 ployee making the inspection obtains a sample of 

 any such food, and an analysis is made of such 

 rample for the purpose of as:ertaining whether such 

 food consists in whole or in part of any filthy, putrid, 

 or decomposed substance, or is otherwise unfit for 

 food, a copy of the results of such analysis shall be 

 furnished promptly to the owner, operator, or agent 

 in charge. 



(e) Every person required under section 3601 or 

 360j(g) to maintain records and every person who 

 is in charge or custody of such records shall, upon 

 request of an officer or employee designated by the 

 Secretary, permit such officer or employee at all 

 reasonable times to have access to, and to copy and 

 verify, such records. (June 25, 1938, ch. 675, § 704, 

 52 Stat. 1057; 1940 Reorg, Plan No. IV, § 12, efif. 

 June 30, 1940, 5 F. R. 2422, 54 Stat. 1237; 1953 Reorg. 

 Plan No. 1, § 5, efif. Apr. 11, 1953, 18 F. R. 2053, 67 

 Stat. 631; Aug. 7, 1953, ch. 350, § i, 67 Stat. 476; 

 Oct. 10, 1962, Pub. L. 87-781, title II, § 201 (a), (b), 

 76 Stat. 792; Pub. L. 94-295, § 6, May 28. 1976, 90 

 Stat. 581.) 



Amendments 



1962— .Subsec. (a). Pub. L. 87-781. 1201(a), extended 

 tlie Inspection, where prescription drugs are manvfac- 

 tured, processed, packed, or held, to ail things bearing on 

 whether adulterated or misbranded drugs, or any which 

 may not be manufactured. Introduced In Interstate com- 

 merce, or sold or offered for sale under any provision of 

 this chapter, have twen or are being manufactured, proc- 

 essed, packed, transported or held In any such place, or 

 otherwise bearing on violation of this chapter, but ex- 



