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ADMINISTRATION, DEPARTMENT OF HEALTH
AND HUMAN SERVICES—(Continued)
Medical devices: reports of corrections and remov-
manufacturers and initial importers of devices
Part 890 892 8S5 898
Physical medicine devices ........
Page 476 493 506
1000 1002 1003 1004
545 554 563
ting products .......
ultrasonic radiation-emitting products ........
SUBCHAPTER K (RESERVED]
SUBCHAPTER 1-REGULATIONS UNDER CERTAIN OTHER ACTS
1210 Regulations under the Federal Import Milk Act .... 1230 Regulations under the Federal Caustic Poison Act 1240 Control of communicable diseases
....... 1250 Interstate conveyance sanitation 1251-1269 [Reserved] 1270 Human tissue intended for transplantation ........ 1271 Human cells, tissues, and cellular and tissue-based
products .... 1272–1299 (Reserved]
Subpart A [Reserved] Subpart B-Requirements for Specific
Sec. 800.10 Contact lens solutions; sterility. 800.12 Contact lens solutions and tablets;
tamper-resistant packaging. 800.20 Patient examination gloves and sur
geons' gloves; sample plans and test method for leakage defects; adulteration.
Subpart C-Administrative Practices and
Procedures 800.55 Administrative detention.
AUTHORITY: 21 U.S.C. 321, 334, 351, 352, 355, 360e, 360i, 360k, 361, 362, 371.
Subpart A [Reserved)
this chapter, this ruling is applicable to ophthalmic preparations that are regulated as drugs.
(3) The containers shall be sterile at the time of filling and closing, and the container or individual carton shall be so sealed that the contents cannot be used without destroying the seal. The packaging and labeling of these solutions shall also comply with $ 800.12 on tamper-resistant packaging requirements.
(b) Liquid ophthalmic preparations packed in multiple-dose containers should:
(1) Contain one or more suitable and harmless substances that will inhibit the growth of microorganisms; or
(2) Be so packaged as to volume and type of container and so labeled as to duration of use and with such necessary warnings as to afford adequate protection and minimize the hazard of injury resulting from contamination during use.
(c) Eye cups, eye droppers, and other dispensers intended for ophthalmic use should be sterile, and may be regarded as falling below their professed standard of purity or quality if they are not sterile. These articles, which are regulated as medical devices unless packaged with the drugs with which they are to be used, should be packaged so as to maintain sterility until the package is opened and be labeled, on or within the retail package, so as to afford adequate directions and necessary warnings to minimize the hazard of injury resulting from contamination during use.
Subpart B-Requirements for
Specific Medical Devices $ 800.10 Contact lens solutions; ste
rility. (a)(1) Informed medical opinion is in agreement that all preparations offered or intended for ophthalmic use, including contact lens solutions, should be sterile. It is further evident that such preparations purport to be of such purity and quality as to be suitable for safe use in the eye.
(2) The Food and Drug Administration concludes that all such preparations, if they are not sterile, fall below their professed standard of purity or quality and may be unsafe. In a statement of policy issued on September 1, 1964, the Food and Drug Administration ruled that liquid preparations offered or intended for ophthalmic use that are not sterile may be regarded as adulterated within the meaning of section 501(c) of the Federal Food, Drug, and Cosmetic Act (the act), and, further, may be deemed misbranded within the meaning of section 502(j) of the act. By this regulation, this ruling is applicable to all preparations for ophthalmic use that are regulated as medical devices, i.e., contact lens solutions. By the regulation in $200.50 of
[47 FR 50455, Nov. 5, 1982]
8 800.12 Contact lens solutions and
tablets; tamper-resistant packaging. (a) General. Unless contact lens solutions used, for example, to clean, disinfect, wet, lubricate, rinse, soak, or store contact lenses and salt tablets or other dosage forms to be used to make any such solutions are packaged in tamper-resistant retail packages, there is the opportunity for the malicious adulteration of these products with
risks both to individuals who unknow- a visual indication of package integingly 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, distribuucts. 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 reand 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 feaproducts vulnerable to malicious adul ture of the package. The labeling stateteration 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 tampersafety and effectiveness of the products resistant feature of the package is contained therein. A contact lens solu- breached or missing. If the tamper-retion or tablet or other dosage form to sistant feature chosen to meet the rebe used to make such a solution for re- quirement in paragraph (b) of this sectail 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 labelated under section 501 of the act or ing statement. For example, the labelmisbranded 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 packuct regulated as a medical device that aging and labeling requirements. A manis a solution intended for use with con- ufacturer or packer may request an extact lenses, e.g., for cleaning, dis- emption from the packaging and labelinfecting, wetting, lubricating, rinsing, ing requirements of this section. A resoaking, 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 petiA tamper-resistant package is one hav tion for an exemption from a requireing an indicator or barrier to entryment of this section is required to conwhich, 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 chaphas occurred. To reduce the likelihood ter. This information collection reof substitution of a tamper-resistant quirement has been approved by the Offeature after tampering, the indicator fice of Management and Budget under or barrier to entry is required to be dis- number 0910-0150. tinctive by design or by the use of an (e) Products subject to approved preidentifying characteristic (e.g., a pat- market approval applications. Holders of tern, name, registered trademark, logo, approved premarket approval applicaor picture). For purposes of this sec- tions for products subject to this section, the term “distinctive by design”. tion are required to submit supplemeans the package cannot be dupli- ments to provide for changes in packcated with commonly available mate aging to comply with the requirement rial or through commonly available of paragraph (b) of this section unless processes. A tamper-resistant package these changes do not affect the commay involve an immediate-container position of the container, the torque and closure system or secondary-con- (tightness) of the container, or the tainer or carton system or any com- composition of the closure component bination of systems intended to provide in contact with the contents (cap liner