SUBCHAPTER H—MEDICAL DEVICES PART 800—GENERAL this chapter, this ruling is applicable to ophthalmic preparations that are Subpart A [Reserved] regulated as drugs. (3) The containers shall be sterile at Subpart B—Requirements for Specific the time of filling and closing, and the Medical Devices container or individual carton shall be Sec. so sealed that the contents cannot be 800.10 Contact lens solutions; sterility. used without destroying the seal. The 800.12 Contact lens solutions and tablets; packaging and labeling of these solu- tamper-resistant packaging. tions shall also comply with § 800.12 on 800.20 Patient examination gloves and sur- tamper-resistant packaging require- geons’ gloves; sample plans and test ments. method for leakage defects; adulteration. (b) Liquid ophthalmic preparations Subpart C—Administrative Practices and packed in multiple-dose containers Procedures should: (1) Contain one or more suitable and 800.55 Administrative detention. harmless substances that will inhibit AUTHORITY: 21 U.S.C. 321, 334, 351, 352, 355, the growth of microorganisms; or 360e, 360i, 360k, 361, 362, 371. (2) Be so packaged as to volume and type of container and so labeled as to Subpart A [Reserved] duration of use and with such nec- essary warnings as to afford adequate Subpart B—Requirements for protection and minimize the hazard of Specific Medical Devices injury resulting from contamination during use. § 800.10 Contact lens solutions; ste- (c) Eye cups, eye droppers, and other rility. dispensers intended for ophthalmic use (a)(1) Informed medical opinion is in should be sterile, and may be regarded agreement that all preparations offered as falling below their professed stand- or intended for ophthalmic use, includ- ard of purity or quality if they are not ing contact lens solutions, should be sterile. These articles, which are regu- sterile. It is further evident that such lated as medical devices unless pack- preparations purport to be of such pu- aged with the drugs with which they rity and quality as to be suitable for are to be used, should be packaged so safe use in the eye. as to maintain sterility until the pack- (2) The Food and Drug Administra- age is opened and be labeled, on or tion concludes that all such prepara- within the retail package, so as to af- tions, if they are not sterile, fall below ford adequate directions and necessary their professed standard of purity or warnings to minimize the hazard of in- quality and may be unsafe. In a state- jury resulting from contamination dur- ment of policy issued on September 1, ing use. 1964, the Food and Drug Administra- tion ruled that liquid preparations of- [47 FR 50455, Nov. 5, 1982] fered or intended for ophthalmic use that are not sterile may be regarded as § 800.12 Contact lens solutions and tablets; tamper-resistant packaging. adulterated within the meaning of sec- tion 501(c) of the Federal Food, Drug, (a) General. Unless contact lens solu- and Cosmetic Act (the act), and, fur- tions used, for example, to clean, dis- ther, may be deemed misbranded with- infect, wet, lubricate, rinse, soak, or in the meaning of section 502(j) of the store contact lenses and salt tablets or act. By this regulation, this ruling is other dosage forms to be used to make applicable to all preparations for oph- any such solutions are packaged in thalmic use that are regulated as med- tamper-resistant retail packages, there ical devices, i.e., contact lens solu- is the opportunity for the malicious tions. By the regulation in § 200.50 of adulteration of these products with 7 VerDate Sep<11>2014 16:44 May 08, 2017 Jkt 241077 PO 00000 Frm 00015 Fmt 8010 Sfmt 8010 Q:\21\21V8.TXT 31 lpowell on DSK54DXVN1OFR with $$_JOB § 800.12 21 CFR Ch. I (4–1–17 Edition) risks both to individuals who unknow- a visual indication of package integ- ingly purchase adulterated products rity. The tamper-resistant feature and with loss of consumer confidence shall be designed to and shall remain in the security of the packages of over- intact when handled in a reasonable the-counter (OTC) health care prod- manner during manufacture, distribu- ucts. The Food and Drug Administra- tion, and retail display. tion has the authority and responsi- (c) Labeling. Each retail package of a bility under the Federal Food, Drug, product covered by this section is re- and Cosmetic Act (the act) to establish quired to bear a statement that is a uniform national standard for tam- prominently placed so that consumers per-resistant packaging of those OTC are alerted to the tamper-resistant fea- products vulnerable to malicious adul- ture of the package. The labeling state- teration that will improve the security ment is also required to be so placed of OTC packaging and help assure the that it will be unaffected if the tamper- safety and effectiveness of the products resistant feature of the package is contained therein. A contact lens solu- breached or missing. If the tamper-re- tion or tablet or other dosage form to sistant feature chosen to meet the re- be used to make such a solution for re- quirement in paragraph (b) of this sec- tail sale that is not packaged in a tam- tion is one that uses an identifying per-resistant package and labeled in characteristic, that characteristic is accordance with this section is adulter- required to be referred to in the label- ated under section 501 of the act or ing statement. For example, the label- misbranded under section 502 of the ing statement on a bottle with a shrink act, or both. band could say ‘‘For your protection, (b) Requirement for tamper-resistant this bottle has an imprinted seal package. Each manufacturer and pack- around the neck.’’ er who packages for retail sale a prod- (d) Requests for exemptions from pack- uct regulated as a medical device that aging and labeling requirements. A man- is a solution intended for use with con- ufacturer or packer may request an ex- tact lenses, e.g., for cleaning, dis- emption from the packaging and label- infecting, wetting, lubricating, rinsing, ing requirements of this section. A re- soaking, or storing contact lenses or quest for an exemption is required to tablets or other dosage forms to be be submitted in the form of a citizen used to make any such solution shall petition under § 10.30 of this chapter package the product in a tamper-resist- and should be clearly identified on the ant package, if this product is acces- envelope as a ‘‘Request for Exemption sible to the public while held for sale. from Tamper-resistant Rule.’’ A peti- A tamper-resistant package is one hav- tion for an exemption from a require- ing an indicator or barrier to entry ment of this section is required to con- which, if breached or missing, can rea- tain the same kind of information sonably be expected to provide visible about the product as is specified for evidence to consumers that tampering OTC drugs in § 211.132(d) of this chap- has occurred. To reduce the likelihood ter. of substitution of a tamper-resistant (e) Products subject to approved pre- feature after tampering, the indicator market approval applications. Holders of or barrier to entry is required to be dis- approved premarket approval applica- tinctive by design or by the use of an tions for products subject to this sec- identifying characteristic (e.g., a pat- tion are required to submit supple- tern, name, registered trademark, logo, ments to provide for changes in pack- or picture). For purposes of this sec- aging to comply with the requirement tion, the term ‘‘distinctive by design’’ of paragraph (b) of this section unless means the package cannot be dupli- these changes do not affect the com- cated with commonly available mate- position of the container, the torque rial or through commonly available (tightness) of the container, or the processes. A tamper-resistant package composition of the closure component may involve an immediate-container in contact with the contents (cap liner and closure system or secondary-con- or innerseal) as these features are de- tainer or carton system or any com- scribed in the approved premarket ap- bination of systems intended to provide proval application. Any supplemental 8 VerDate Sep<11>2014 16:44 May 08, 2017 Jkt 241077 PO 00000 Frm 00016 Fmt 8010 Sfmt 8010 Q:\21\21V8.TXT 31 lpowell on DSK54DXVN1OFR with $$_JOB Food and Drug Administration, HHS § 800.20 premarket approval application under ulations without regard to the retail this paragraph is required to include level effective date. data sufficient to show that these changes do not adversely affect the [47 FR 50455, Nov. 5, 1982; 48 FR 1706, Jan. 14, 1983, as amended at 48 FR 16666, Apr. 19, 1983; product. 48 FR 37625, Aug. 19, 1983; 53 FR 11252, Apr. 6, (f) Effective date. Each product sub- 1988; 73 FR 34859, June 19, 2008] ject to this section is required to com- ply with the requirements of this sec- EFFECTIVE DATE NOTE: A document pub- lished at 48 FR 41579, Sept. 16, 1983, stayed tion on the dates listed below except to the effective date of § 800.12(f)(3) until further the extent that a product’s manufac- notice. turer or packer has obtained an exemp- tion from a packaging or labeling re- § 800.20 Patient examination gloves quirement: and surgeons’ gloves; sample plans (1) Initial effective date for packaging and test method for leakage defects; requirements. (i) The packaging require- adulteration. ment in paragraph (b) of this section is (a) Purpose.