Ophthaimic Practice Rules

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FEDERAL TRADE COMMISSION 16 CFR Part 456

Ophthaimic Practice Rules

AGENCY: Federal Trade Commission. ACTION: Final Trade regulation rule.

SUMMARY: The Federal Trade Commission has decided to remove portions of 16 CFR part 456, Ophthalmic Practice Rules, from the Code of Federal Regulations and to renumber the remaining portions of part 456. The portions to be removed prohibit state bans on the commercial practice of optometry and have been overturned by the U.S. Court of Appeals, D.C. Circuit. The remaining portions, to be renumbered, require optometrists and ophthalmologists to release eyeglass prescriptions. These portions were not overturned by the court and remain in effect.

EFFECTIVE DATE: May 1, 1992.

FOR FURTHER INFORMATION CONTACT:- Renee Kinscheck, Division of Service

Industry Practices, Federal Trade Commission, 6th Street and Pennsylvania Avenue NW., Washington DC (202) 326-3283.

SUPPLEMENTARY INFORMATION: On March 13, 1989, the Federal Trade Commission issued a Trade Regulation Rule on Ophthalmic Practice Rules. 54 FR 10285. In large part, this rule would have removed state prohibitions on the commercial practice of optometry (the “Eyeglasses II’ Rule). The Commission also promulgated several amendments to the previously existing Ophthalmic Practice Rules (the “Eyeglasses I” rule), which requires optometrists and ophthalmologists to release eyeglass prescriptions to their patients. On August 28, 1990, the Court of Appeals for the D.C. Circuit vacated the Eyeglasses II rule, which would have removed state bans on commercial practice. California State Board of Optometry v. FTC, 910 F.2d 976 (D.C. Cir. 1990), reh’g denied, January 8, 1991. The court did not overturn the Commission's amendments to the Eyeglasses I prescription release rule, a rule which had previously been upheld by the court. American Optometric Association v. FTC, 626 F.2d 897 (D.C. Cir. 1980).

The Commission has amended the rule by removing the following sections of 16 CFR part 456: § 456.1(g) & (i),

§ 456.4, § 456.5(a), (b) and (d); and by redesignating § 456.1(h) and § 456.5(c) and 456.1(g) and 456.4 respectively.

Accordingly, 16 CFR part 456 is revised to read as follows:

PART 456—OPHTHALMIC PRACTICE RULES

Sec.

456.1 Definitions.

456.2. Separation of examination and dispensing.

456.3 Federal or State employees.

456.4 Declaration of Commission Intent.

Authority: 15 U.S.C. 57a; 5 U.S.C. 552.

§ 456.1 Definitions.

(a) A patient is any person who has" had an eye examination.

(b) An eye examination is the process of determining the refractive condition of a person's eyes or the presence of any visual anomaly by the use of objective or subjective tests.

(c) Ophthalmic goods are eyeglasses, or any component of eyeglasses, and contact lenses.

(d) Ophthalmic services are the measuring, fitting, and adjusting of ophthalmic goods subsequent to an eye examination.

(e). An ophthalmologist is any Doctor of Medicine or Osteopathy who performs eye examinations.

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(f) An optometrist is any Doctor of Optometry.

(g) A prescription is the written specifications for lenses for eyeglasses which are derived from an eye examination, including all of the information specified by state law, if any, necessary to obtain lenses for eyeglasses.

§ 456.2 Separation of examination and dispensing.

It is an unfair act or practice for an ophthalmologist or optometrist to:

(a} Fail to provide to the patient one copy of the patient's prescription immediately after the eye examination is completed. Provided: An ophthalmologist or optometrist may refuse to give the patient a copy of the patient's prescription until the patient has paid for the eye examination, but only if that ophthalmologist or optometrist would have required immediate payment from that patient had the examination revealed that no ophthalmic goods were required;

(b) Condition the availability of an eye examination to any person on a requirement that the patient agree to purchase any ophthalmic goods from the ophthalmologist or optometrist;

(c) Charge the patient any fee in addition to the ophthalmologist’s or optometrist’s examination fee as a condition to releasing the prescription to the patient. Provided: An ophthalmologist or optometrist may charge an additional fee for verifying ophthalmic goods dispensed by another seller when the additional fee is imposed at the time the verification is performed; or

(d) Place on the prescription, or require the patient to sign, or deliver to the patient a form or notice waiving or disclaiming the liability or responsibility of the ophthalmologist or optometrist for the accuracy of the eye examination or the accuracy of the ophthalmic goods and services dispensed by another seller.

§ 456.3 Federal or State employees.

This rule does not apply to ophthalmologists or optometrists employed by any Federal, State or local government entity.

§ 456.4 Deciaration of Commission intent.

In prohibiting the use of waivers and disclaimers of liability in § 456.2(d}, it is not the Commission’s intent to impose liability on av, ophthalmologist-or optometrist for the ophthalmic goods and services dispensed by another seller

pursuant to the ophthalmologist's or optometrist’s prescription.

Donald S. Clark,

Secretary.

[FR Doc. 92-9947 Filed 4-30-92; 8:45 am} BILLING CODE 6750-01-M

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration 21 CFR Part 5

Delegations of Authority and Organization; Issuance of Written Notices

AGENCY: Food and Drug Administration, HHS.

-ACTION: Final rule.

SUMMARY: The Food and Drug Administration (FDA) is amending the regulations for delegations of authority relating to the issuance of written notices concerning failure to file patent information and to comply with requirements pertaining to current good manufacturing practices and labeling for new drugs, new animal drugs, and feeds bearing or containing new animal drugs from the Commissioner of Food and | Drugs to certain FDA officials. This action is being taken to make the process of issuing written notices more efficient.

EFFECTIVE DATE: May 1, 1992.

FOR FURTHER INFORMATION CONTACT: Ellen Rawlings, Division of Management Systems and Policy (HFA-340), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443- 4976.

SUPPLEMENTARY INFORMATION: FDA is amending the delegations of authority by adding new § 5.38 issuance of written notices concerning patent information, current good manufacturing practices and false or misleading labeling of new drugs, new animal drugs, and feeds bearing or containing new animal drugs. Under section 505(e) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(e)), § 5.38 redelegates the Commissioner’s authority regarding the issuance of written notices to the Director, Deputy Director, and other officials of the Center for Drug Evaluation and Research. Under sections 512(e) and 512 (m)(4)(B)(ii) and (m)(4)(B){iii) of the act (21 U.S.C. 360b(e) and 360b (m){4)(B)(ii) and (m)(4)(B)(iii)), the Commissioner's authority regarding the issuance of written notices is redelegated to the Director, Deputy Director, and other officials of the Center for Veterinary Medicine. These

redelegations will make the process of issuing written notices more efficient.

Further redelegation of the authority is not authorized. Authority delegated to a position by title may be exercised by a person officially designated to serve'in such position in an acting capacity or on a temporary basis.

List of Subjects in 21 CFR Part 5

Authority delegations (Government agencies), Imports, Organization and functions (Government agencies).

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 5 is amended as follows:

PART 5—DELEGATIONS OF AUTHORITY AND ORGANIZATION

1. The authority citation for 21 CFR part 5 is revised to read as follows:

Authority: 5 U.S.C. 504, 552, App. 2; 7 U.S.C, 138a, 2271; 15 U.S.C. 638, 1261-1282, 3701- 3711a; secs. 2-12 of the Fair Packaging and Labeling Act (15 U.S.C. 1451-1461); 21 U.S.C. 41-50, 61-63, 141-149, 467f, 679(b), 801-886, 1031-1309; secs. 201-903 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321-394); 35 U.S.C. 156; secs. 301, 302, 303, 307, 310, 311, 351, 352, 361, 362, 1701-1706; 2101 of the Public Health Service Act (42 U.S.C. 241, 242, 242a, 2421, 242n, 243, 262, 263, 264, 265, 300u- 300u-5, 300aa—1); 42 U.S.C. 1395y, 3246b, 4332, 4831(a), 10007-10008; E.O. 11490, 11921, and 12591.

2. New § 5.38 is added to subpart B to read as follows:

§ 5.38 Issuance of written notices concerning patent information, current good manufacturing practices and false or misleading labeling of new drugs, new animal drugs, and feeds bearing or containing new animal drugs.

(a) The following officials are authorized to perform all the functions of the Commissioner of Food and Drugs under section 505(e) of the Federal Food, Drug, and Cosmetic Act (the act) regarding the issuance of written notices.

(1) The Director and Deputy Director, Center for Drug Evaluation and Research (CDER).

(2) The Director and Deputy Director, Office of Compliance, CDER.

(3) The Director and Deputy Director, Division of Drug Labeling Compliance, Office of Compliance, CDER.

(4) The Director and Deputy Director, Division of Manufacturing and Product Quality, Office of Compliance, CDER.

(5) The Director and Deputy Director, Division of Drug Quality Evaluation, Office of Compliance, CDER.

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(6) The Director and Deputy Director, Division of Scientific Investigations, Office of Compliance, CDER.

(7) Regional Food and Drug Directors.

(8} District Directors.

(b) The following officials are authorized to perform all the functions of the Commissioner of Food and Drugs under sections 512(e) and 512 (m)(4)(B)(ii) and (m)(4)(B)(iii) of the act regarding the issuance of written notices.

(1) The Director and Deputy Director, Center for Veterinary Medicine {(CVM).

(2) The Director and Deputy Director, Office of Surveillance and Compliance, CVM.

(3) The Director, Division of Compliance, Office of Surveillance and Compliance, CVM.

(4) Regional Food and Drug Directors.

(5), District Directors.

Dated: April 24, 1992.

David A. Kessler,

Commissioner of Food and Drugs.

{FR Doc. 92-10191 Filed 4-30-92; 8:45 am] BILLING CODE 4160-01-M

DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1308

Schedules of Controlled Substances Temporary Placement of Methcathinone Into Schedule |

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Final rule.

SUMMARY: This final rule is issued by the Administrator of the Drug Enforcement Administration (DEA) to temporarily place methcathinone into Schedule I of the Controlled Substances Act (CSA) pursuant to the emergency scheduling provisions of the CSA. This action is based on a finding by the DEA Administrator that the scheduling of methcathinone, at least on a temporary basis, is necessary to avoid an imminent hazard to the public safety. As a result of this rule, the regulatory controls and criminal sanctions imposed on Schedule I substances under the CSA will be applicable to the manufacture, distribution and possession of methcathinone.

EFFECTIVE DATE: May 1, 1992.

FOR FURTHER INFORMATION CONTACT: Howard McClain, Jr., Chief, Drug and Chemical Evaluation Section, Drug Enforcement Administration, Washington, DC 20537, Telephone: (202) 307-7183,

SUPPLEMENTARY INFORMATION: The Comprehensive Crime Control Act 1984 amended section 201 of the CSA (21 U.S.C. 811 et seq.) to give the Attorney General the authority to temporarily place a substance into Schedule I of the CSA if it is found that such action is necessary to avoid an imminent hazard to the public safety. The Attorney General has delegated this authority under 21 U.S.C. 811 to the Administrator of the DEA (28 CFR 0.100). A substance may be temporarily scheduled pursuant to the emergency scheduling provisions of the CSA if that substance is not listed in any schedule under section 202 of the CSA (21 U.S.C. 812) or if there is no approval or exemption in effect under 21 U.S.C. 355 of the Food, Drug and Cosmetic Act for the substance.

A notice of intent to temporarily place methcathinone into Schedule I of the CSA was published in the Federal Register on March 16, 1992 (57 FR 9080). The Administrator transmitted notice of his intention to temporarily place methcathinone into Schedule I of the CSA to the Assistant Secretary for Health of the Department of Health and Human Services. In response to this notification, the Food and Drug Administration, by letter, has advised DEA that there are no exemptions or approvals in effect under 21 U.S.C. 355 of the Food, Drug and Cosmetic Act for methcathinone. The letter further stated that the Department of Health and Human Services has no objections to DEA's intention to temporarily place methcathinone into Schedule I of the CSA. No other comments were received regarding this matter.

Methcathinone, also called ephedrone or 2-methylamino-1-phenylpropan-1-one, isan N-monomethylated phenylisopropylamine that has a chemical structure similar to that of methamphetamine. Limited pharmacological data indicate that methcathinone produces amphetaminelike, psychomotor stimulant activity in laboratory animals.

Five clandestine laboratories producing methcathinone have been encountered. Methcathinone is sold on the street as a “legal” stimulant under the street name, “cat.” It is distributed as a powdered material and is administered via nasal inhalation.

In accordance with 21 U.S.C. 811(h)(3), the Administrator has considered the following factors regarding methcathinone: (1) Its history and current pattern of abuse; (2) the scope, duration and significance of abuse; and (3) what, if any, risk there is to the public health.

Based on methcathinone’s structural similarity to amphetamine and

methamphetamine, its amphetamine-like central nervous system stimulant properties in animals, its clandestine production, distribution and abuse, the Administrator, pursuant to 21 U.S.C. 811{h) of the CSA and 28 CFR 0.100, finds that temporary placement of methcathinone into Schedule I of the CSA is necessary to avoid an imminent hazard to the public safety.

The following regulations are effective with respect to methcathinone on May 1, 1992, except that individuals registered with DEA in accordance with part 1301 or part 1311 of title 21 of the Code of Federal Regulations, who currently possess methcathinone may continue to do so pending DEA’s receipt of an application for amended registration no later than June 1, 1992:

1. Registration. Any person who manufactures, distributes, engages in research, imports or exports methcathinone or who proposes to engage in the manufacture, distribution, importation or exportation of methcathinone or conduct research with methcathinone must be registered to conduct such activities in accordance with parts 1301 and 1311 of title 21 of the Code of Federal Regulations.

2. Security. Methcathinone must be manufactured, distributed and stored in accordance with §§ 1301.71-1301.76 of title 21 of the Code of Federal Regulations.

3. Labeling and Packaging. All labels and labeling for commercial containers of methcathinone must comply with the requirements of §§ 1302.03-1302.05, 1302.07 and 1302.08 of title 21 of the Code of Federal Regulations.

4. Quotas. All persons required to obtain quotas for methcathinone must submit applications pursuant to §§ 1303.12 and 1303.22 of title 21 of the Code of Federal Regulations.

5. Inventory. Registrants in possession of methcathinone are required to take inventories of all stocks of this substance on hand pursuant to §§ 1304.11-1304.19 of title 21 of the Code of Federal Regulations.

6. Records. All registrants required to keep records pursuant to §§ 1304.21- 1304.27 of title 21 of the Code of Federal Regulations must do so regarding methcathinone.

7. Reports. All registrants engaged in the manufacture, packaging, labeling or distribution of methcathinone are required to submit reports in accordance with §§ 1304.35-1304.37 of title 21 of the’ Code of Federal Regulations.

8. Order Forms. Each distribution of methcathinone requires the use of an order form pursuant to §§ 1305.01-

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1305.16 of title 21 of the Code of Federal Regulations.

9. Importation and Exportation. All importation and exportation of methcathinone must be in compliance with part 1312 of title 21 of the Code of Federal Regulations.

10. Criminal Liability. Any activity with methcathinone not authorized by or in violation of the CSA or the Controlled Substances Import and Export Act occurring on or after May 1, 1992 is unlawful.

The Administrator of the DEA hereby certifies that the temporary placement of methcathinone into Schedule I of the CSA will have no significant impact upon entities whose interests must be considered under the Regulatory Flexibility Act, 5 U.S.C. 601 et seg. This action involves the temporary control of a substance with no currently approved medical use or manufacture in the United States.

This final rule is not a major rule for the purposes of Executive Order 12291 (46 FR 13193) of February 17, 1981. It has been determined that drug scheduling matters are not subject to review by the Office of Management and Budget (OMB) pursuant to the provisions of Executive Order 12291. Accordingly, this emergency scheduling action is not subject to the provisions of Executive Order 12778 which are contingent upon review by OMB. This regulation both responds to an emergency situation posing an imminent danger to the public health and safety, and is essential to a criminal law enforcement function of the United States. Accordingly, it is not subject to the 90-day moratorium on regulations ordered by the President of the United States in his memorandum of January 28, 1992.

This action has been analyzed in accordance with the principles and criteria in Executive Order 12612, and it has been determined that this final rule does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment.

List of Subjects in 21 CFR Part 1308

Administrative practice and procedure, Drug traffic control, Narcotics, Prescription drugs.

Under the authority vested in the Attorney General by section 201(h) of the CSA (21 U.S.C. 811(h)), and delegated to the Administrator of DEA by Department of Justice regulations (28 CFR 0.100), the Administrator hereby amends 21 CFR part 1308 as follows:

PART 1308—SCHEDULES OF CONTROLLED SUBSTANCES

1. The authority citation for 21 CFR part 1308 continues to read as follows:

Authority: 21 U.S.C. 811, 812, 871b, unless otherwise noted.

2. Paragraph (g)(3) is added to § 1308.11 to read as follows:

§ 1308.11 Schedule | * * - * +

te *

(3) Methcathinone (Some other names: 2- Methylamino-1-Phenylpropan-1-one; Ephedrone; Monomethylpropion; UR 1491, its salts, optical isomers, and salts of optical isomers—1237.

Dated: April 23, 1992.

Robert C. Bonner,

Administrator, Drug Enforcement Administration.

[FR Doc. 92-10282 Filed 4-30-92; 8:45 am]